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The Proactive Community Case Management (ProCCM) trial in Mali reinforced the health system across both arms with user fee removal, professional Community Health Workers (CHWs), and upgraded primary health centres (PHCs)-and randomized village-clusters to receive proactive home visits by CHWs (intervention) or fixed site-based services by passive CHWs (control). Across both arms, sick children's 24-hour treatment and pregnant women's four or more antenatal visits doubled, and under-five mortality halved, over three years compared to baseline. In the intervention arm, proactive CHW home visits had modest effects on children's curative and women's antenatal care utilization, but no effect on under-five mortality, compared to the control arm. We aimed to explain these results by examining implementation, mechanisms, and context in both arms. We conducted a process evaluation with a mixed method convergent design that included 79 in-depth interviews with providers and participants over two time-points, surveys with 195 providers, and secondary analyses of clinical data. We embedded realist approaches in novel ways to test, refine, and consolidate theories about how ProCCM worked, generating three context-intervention-actor-mechanism-outcome nodes that unfolded in a cascade. First, removing user fees and deploying professional CHWs in every cluster enabled participants to seek health sector care promptly and created a context of facilitated access. Second, health systems support to all CHWs and PHCs enabled equitable, respectful, quality healthcare, which motivated increased, rapid utilization. Third, proactive CHW home visits facilitated CHWs and participants to deliver and seek care, and build relationships, trust, and expectations, but these mechanisms were also activated in both arms. Addressing multiple structural barriers to care, user fee removal, professional CHWs, and upgraded clinics interacted with providers' and patients' agency to achieve rapid care and child survival in both arms. Proactive home visits expedited or compounded mechanisms that were activated and changed the context across arms.

Background: Inpatient rehabilitation therapies can be applied for in Germany by patients of working age to support their return to work. However, there are some problems that impede an easy and uncomplicated application process. An interdisciplinary case management approach for rehabilitation care planning was developed to facilitate the access to rehabilitation. Case conferences (CCs) were held with relevant stakeholders and took place on a digital communication platform. We conducted a qualitative process evaluation to understand the implementation of the intervention and to identify contextual factors as well as mechanisms for a successful implementation in the context of primary care. Methods: The process evaluation included interviews with primary care physicians (PCPs), patients and stakeholders involved in the intervention process. Reflexive thematic analysis was used to analyse the data. Emerging themes were structured according to the Donabedian framework of structure, process and outcomes. Results: A total of 18 interviews were conducted. Important results included the desire for more patient involvement and case management. Patients especially valued the opportunity to receive support from a social worker. Limitations of the platform related to usability and limited opportunities for stakeholder communication. Despite training for PCPs, several problems arose regarding the clarity of the intervention process. Patients were satisfied with their application process and the treatments offered, while PCPs reported an increase in workload. Conclusions: A digitalisation of the application procedure for rehabilitation and further treatment options is acceptable to patients and personal support of a social worker is particularly valued. However, patients should be included in the CC in terms of a shared decision-making process. The digital platform requires sufficient training and adjustments have to be made to enhance usability and to improve the efficiency of the process for PCPs. Overall, the exchange between the various stakeholders in the CC is considered particularly useful in more complex cases. Trial registration: DRKS German Clinical Trials Register, DRKS0 00242 07. Registered on 22 March 2021. [ABSTRACT FROM AUTHOR]

Background: Musculoskeletal disorders are commonly treated in primary healthcare and may, if not treated adequately, entail a risk for long-term disability and sickness absence. A team-based rehabilitation intervention (PREVention of Sickness Absence for Musculoskeletal disorders, PREVSAM) was evaluated in a randomised controlled trial. The purpose of this study was to evaluate the process of implementing the PREVSAM model in primary care rehabilitation. Methods: This process evaluation was conducted alongside the trial, collecting quantitative and qualitative data to evaluate how the PREVSAM model was implemented, mechanisms of impact, and contextual factors. Acceptability, feasibility, appropriateness, adaptations, training and support, resources, recruitment, reach, retention, dose, fidelity, and readiness for change were investigated. Qualitative data were collected from healthcare professionals and patients. Results: Eight of 22 invited rehabilitation clinics (36%) and 28 of 54 healthcare professionals (52%) were included in the PREVSAM trial and this process evaluation. Of 507 eligible patients, 261 (51%) were included. Of those, 134 were randomised to the intervention and 129 (96%) were retained. Twelve healthcare professionals and 15 patients participated in the qualitative evaluations. The model's essential components; individual assessments and structured, team-based rehabilitation with clear division of responsibilities agreed in a joint health plan; were generally delivered according to protocol. The optional components early access to psychological treatment and workplace contact were delivered to a lesser extent. Perceived acceptability, feasibility, and appropriateness of the PREVSAM model were moderate to high. Several contextual barriers, in the form of missing prerequisites, affected the implementation. Qualitative data showed that the model, with its holistic view, was appreciated by both healthcare professionals and patients. Conclusions: This process evaluation suggests that PREVSAM is acceptable, feasible and appropriate for patients with MSDs reporting psychological risk factors associated with increased risk for sickness absence. While essential components were implemented with fidelity for most patients, optional components were not. This variability reflects the complexity of the model, its mandatory and optional components, contextual barriers, and the person-centred approach meeting individual patient needs. As all model components were not delivered to all patients, the intervention may have been too similar to treatment as usual to detect differences on a group level. A limitation of the study is that half of the participating rehabilitation clinics withdrew prematurely. [ABSTRACT FROM AUTHOR]

Background: We previously performed a pragmatic cluster randomized controlled trial (RCT) in general practices and older adult care organizations in Poland, the Netherlands, Norway, and Sweden. We found that a multifaceted antibiotic stewardship intervention (ASI) substantially reduced antibiotic use for suspected urinary tract infections (UTIs) in frail older adults compared with usual care. We aimed to evaluate the implementation process of the ASI to provide recommendations for clinical practice. Methods: We conducted a process evaluation alongside the cluster RCT. The ASI consisted of a decision-tool and a toolbox, which were implemented using a participatory-action-research (PAR) approach with sessions for education and evaluation. We documented the implementation process of the intervention and administered a questionnaire to health care professionals (HCPs) from participating organizations in the intervention and usual care clusters. We evaluated the multiple components of the intervention and its implementation following a structured framework. Results: The questionnaire was completed by 254 HCPs from the 38 participating clusters. All components were largely delivered according to plan and evaluated as useful. The decision-tool and toolbox materials were reported to facilitate decision-making on UTIs. Regarding the PAR approach, educational sessions focusing on the distinction between UTIs and asymptomatic bacteriuria were held in all 19 intervention clusters. In 17 out of these 19 clusters, evaluation sessions took place, which were reported to help remind HCPs to implement the ASI. During both sessions, HCPs valued the reflection that took place and the resulting awareness of their behavior. It allowed them to explore implementation barriers and to tailor their local implementation process to overcome these. For example, HCPs organized extra educational sessions or revised local policies to incorporate the use of the decision-tool. Various HCPs took key roles in implementation. Staff changes and the COVID-19 pandemic were important contextual barriers. Conclusions: We found each component of the multifaceted ASI and its implementation to have added value in the process to improve antibiotic prescribing for suspected UTIs in a heterogeneous older adult care setting. We recommend using a multifaceted, multidisciplinary approach that enables HCPs to reflect on their current practice and accordingly tailor local implementation. Trial registration: ClinicalTrials.gov NCT03970356. Registered on May 31, 2019. [ABSTRACT FROM AUTHOR]

ABSTRACT Aim Design Methods Findings Conclusion Reporting Method Patient or Public Contribution To investigate the experience with and progress of the implementation of a Family Support Intervention (FSI) into adult intensive care units (ICUs) as part of the cluster‐randomised FICUS trial.A mixed‐methods process evaluation using a multiple case study approach guided by the normalisation process theory.This study took place between June 2022 and July 2023 in eight Swiss ICUs randomised to the intervention arm. A tailored implementation strategy was used to introduce the multicomponent FSI, consisting of a new family nursing role and a family care pathway, into interprofessional ICU teams. Participants were 40 ICU key clinical partners. Qualitative data were collected twice, early (3–6 months) and mid‐implementation (9–12 months), using small group interviews. A questionnaire with psychometric measures (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Intervention Appropriateness Measure, Normalisation Measure Development Questionnaire) was administered at mid‐implementation. RITA pragmatic rapid thematic analysis and descriptive statistics were used to analyse the data. Qualitative and quantitative results were then compared across ICUs (cases).Findings indicated the desired progress of the FSI integration overall and across cases, with high acceptability and appropriateness ratings but only moderate to high feasibility scores. Study‐related barriers were noted in all ICUs (i.e., FSI delivery as part of a clinical trial). Implementation barriers included family nurses' limited capacity and clinician's attitudes towards the FSI. Leadership support and interprofessional collaboration were identified as facilitators. Case‐based, integrated findings yielded two implementation pathways, namely early and protracted adopters.Implementation barriers were related to the feasibility of FSI delivery within the study context that required a high degree of standardisation and protocol adherence. Implementation progress was shaped by an interprofessional culture of family care, sufficient staff and time resources, and leadership support. The study's findings will inform future implementation of complex health interventions in ICUs.Good reporting of a Mixed‐Methods Study (GRAMMS).Within the FICUS trial, a patient and family advisory board with a patient expert, three family members and a patient with own lived experience of critical care collaborate with the research team. [ABSTRACT FROM AUTHOR]

Background: Breastfeeding is a powerful public health intervention that produces long-term health benefits. However, in high-income countries such as Denmark, breastfeeding rates are suboptimal and unequally distributed across socio-economic positions. The 'Breastfeeding – a good start together' intervention, to promote longer duration of exclusive breastfeeding and reduce social inequity, was implemented in a cluster-randomised trial during 2022–2023 across 21 municipalities in two Danish regions. A process evaluation was conducted to assess the implementation, mechanisms of impact, and possible contextual factors affecting the intervention. Methods: The study was guided by the Medical Research Council's guidance for conducting process evaluations and employed a mixed-methods approach in a convergence design. Quantitative data: contextual mapping survey (n = 20), health visitor survey (n = 284), health visitor records from 20 clusters and intervention website statistics. Qualitative data: dialogue meetings (n = 7), focus groups (n = 3) and interviews (n = 8). Results: Overall, the intervention was delivered as planned to intended recipients, with few exceptions. Health visitors responded positively to the intervention, noting that it fitted well within their usual practice and enhanced families' chances of breastfeeding. Mothers expressed having received the intervention with few exceptions, and reacted positively to the intervention. Although health visitors were concerned about the potential stigmatisation of mothers receiving the intensified intervention, none of the interviewed mothers felt stigmatised. Contextual factors impacting the intervention implementation and mechanisms included staff and management turnover, project infrastructure and mothers' context, such as resources, social networks and previous experiences. The overall fidelity of the intervention delivery was high. Conclusions: Health visitors and families responded well to the intervention. Interventions aimed at enabling health care providers to deliver simplified and structured breastfeeding support, in alignment with support provided in other sectors of the health care system, may increase breastfeeding rates and reduce social inequity in breastfeeding, even in international contexts. Trial registration: Clinical Trials: NCT05311631. First posted April 5, 2022. [ABSTRACT FROM AUTHOR]

Background: Chronic diseases such as type 2 diabetes mellitus and coronary heart disease cause medical, social, and economic burdens worldwide. Disease management programs in Germany mostly lack components to improve patients' self-management and health-promoting lifestyles despite clear guideline recommendations. Therefore, a Personalized Self-Management Support Program (P-SUP) was developed, which includes: (1) peer support groups; (2) telephone coaching; (3) feedback reports and, (4) a web portal. This study aims to explore patients' and implementing stakeholders' experiences in the implementation of P-SUP to identify barriers and facilitators to the implementation of the intervention. Methods: A qualitative study was conducted using face-to-face focus group interviews with participating patients and telephone-based one-to-one expert interviews with implementing stakeholders, involved in the delivery of the intervention. The transcribed interview reports were analyzed using qualitative content analysis, and the contents were categorized according to Donabedian's Structure-Process-Outcome framework. Results: A total of six themes among patients (N = 35) and five themes among implementing stakeholders (N = 32) represent the experiences. The patient themes were: (1) technical conditions, (2) indoor facilities, (3) group composition, (4) acceptance of digital components, (5) supervision and feedback and (6) impact on lifestyle behavior. The themes among the implementing stakeholders were: (1) multiprofessional approach, (2) human resources, (3) patient acceptance, (4) supervision and feedback and (5) impact on lifestyle behavior. Conclusions: Multiprofessional interventions such as P-SUP appear to be valuable for patients and implementing stakeholders. Although infrastructural barriers made the implementation of peer support and digital patient education difficult, patients rated the exchange with peers and experts on health-related topics positively. The lack of supervision and feedback during the course of the intervention might be compensated by regular telephone coaching. The findings from this study can be used in future studies to guide researchers and implementing stakeholders and to improve the feasibility and effectiveness of complex interventions in different contexts. Trial registration: The P-SUP study was registered in the German Clinical Trials Register (DRKS) on 16/07/2020 under the registration number DRKS00020592. [ABSTRACT FROM AUTHOR]

Background: Intermediate care (IC) services bridge the transition for older patients from the hospital to the home. Despite the goal of involving individuals in their recovery process, these services often become standardised, leading to communication breakdowns. While evidence-based practices, such as the Four Habits Model (4HM), for effective communication are crucial for enhancing high-quality healthcare, research suggests their integration into routine practice remains limited. In this study, we aimed to investigate the implementation process of the 4HM through a two-day course that engaged healthcare professionals and managers in IC. Methods: We conducted a process evaluation employing qualitative and quantitative methods: (i) individual interviews with three managers and two course participants pre-course, (ii) two focus group interviews with course participants (N = 11) and individual interviews with the same three managers post-course, and (iii) the NoMAD questionnaire (Normalisation MeAsure Development) administered four months later to assess the short- and long-term impact on course participants (N = 14). Reflexive thematic analyses were guided by Normalisation Process Theory (NPT), which offers insight into how new interventions become routine practices. The analysis of the NoMAD involved descriptive statistics. Results: We identified four themes in the qualitative data: (i) Decoding Interactions: Making Sense of the 4HM in IC services, (ii) Fostering Change: Legitimising 4HM Through Staff Engagement, (iii) Harmonising Practice: Integrating 4HM into Complex Situations, and (iv) Embedding Value: Normalising the 4HM into Everyday Work. These themes illustrate the normalisation process of the 4HM course within IC, establishing standard practices. Healthcare professionals and managers highlighted the urgent need to integrate communication skills based on the 4HM into daily care. They noted positive changes in their communication habits following the course. The consistent findings from the NoMAD questionnaire underscore the sustainability of implementing the 4HM programme, as participants continue to utilise it in their clinical practice beyond the initial four-month period. Conclusion: The 4HM course programme was deemed feasible for expansion within IC services. Both managers and staff found its focus on addressing communication breakdowns and readiness for change sensible. The study findings may benefit the stakeholders involved in IC service routines, potentially improving services for older patients and relatives. [ABSTRACT FROM AUTHOR]

Adjuvant endocrine therapy (AET) reduces mortality in early-stage breast cancer, but adherence is low. We developed a multicomponent intervention to support AET adherence comprising: text messages, information leaflet, acceptance and commitment therapy (ACT), and side-effect website. Guided by the multiphase optimization strategy, the intervention components were tested in the ROSETA pilot optimization trial. Our mixed-methods process evaluation investigated component acceptability. The pilot optimization trial used a 24–1 fractional factorial design. Fifty-two women prescribed AET were randomized to one of eight experimental conditions, containing unique component combinations. An acceptability questionnaire was administered 4 months post-randomization, and semi-structured interviews with 20 participants further explored acceptability. Assessments were guided by four constructs of the theoretical framework of acceptability: affective attitude, burden, perceived effectiveness, and coherence. Quantitative and qualitative findings were triangulated to identify agreements/disagreements. There were high overall acceptability scores (median = 14–15/20, range = 11–20). There was agreement between the qualitative and quantitative findings when triangulated. Most participants "liked" or "strongly liked" all components and reported they required low effort to engage in. Between 50% (leaflet) and 65% (SMS) "agreed" or "strongly agreed," it was clear how each component would help adherence. Perceived effectiveness was mixed, with 35.0% (text messages) to 55.6% (ACT) of participants "agreeing" or "strongly agreeing" that each component would improve their adherence. Interview data provided suggestions for improvements. The four components were acceptable to women with breast cancer and will be refined. Mixed-methods and triangulation were useful methodological approaches and could be applied in other optimization trial process evaluations. [ABSTRACT FROM AUTHOR]

Background: The ComEx3 community‐based extended maintenance pulmonary rehabilitation (PR) randomised controlled trial (RCT) aimed to determine the optimal strategy for maintaining the benefits of exercise for people with chronic obstructive pulmonary disease (COPD). We conducted a process evaluation of this RCT to determine if the trial was implemented per protocol, and to explore the barriers and facilitators of the trial, and mechanisms of impact. Methods: This was a mixed methods study consisting of analysis of PR class records, study diaries and interviews of those involved in the trial. We developed a reporting framework from available literature and performed a content analysis. Results: Eleven of the 12 participants in the intervention group attended ≥70% of available classes before the trial was terminated due to the COVID‐19 pandemic. Analysis of the study diaries found that adherence to the home exercise program was higher in the intervention than the control group. Analyses of interviews (n = 21) highlighted the complexity of standardising the processes across multiple sites, but revealed behaviour change amongst class physiotherapists who were able to conform with the required processes. Facilitators of participation included the desire to improve function and quality of life, while barriers included illnesses and lack of motivation. Mechanisms of impact included confidence in exercising and benefits from the education sessions. Conclusions: The ComEx3 RCT was implemented as planned largely due to commitment by the research team and the desire by patients to improve their quality of life by attending a PR program that they are familiar with. Successful implementation of PR RCTs requires good organisational skills, clear and consistent trial documentation, broad understanding of participant needs while being conscious of challenges experienced by people with COPD, and dedication by everyone involved in the RCT. So What?: This article shows the importance of running a process evaluation alongside an RCT. Although this RCT did not progress to completion, this process evaluation which was guided by a robust framework, will provide guidance for future interventions in this area. [ABSTRACT FROM AUTHOR]

Aims: The DAFNEplus programme seeks to promote sustained improvements in glycaemic management by incorporating techniques from behavioural science. It includes five sessions of structured individual support delivered over 12 months following group education. As part of a broader evaluation, and to inform decision‐making about roll‐out in routine care, we explored participants' experiences of, and engagement with, that individual support. Methods: We interviewed DAFNEplus participants (n = 28) about their experiences of receiving individual support and the impact they perceived it as having on their self management practices. We analysed data thematically. Results: Participants described several important ways individual support had helped strengthen their self management, including: consolidating and expanding their understandings of flexible intensive insulin therapy; promoting ongoing review and refinement of behaviour; encouraging continued and effective use of data; and facilitating access to help from healthcare professionals to pre‐empt or resolve emergent difficulties. Participants characterised themselves as moving towards independence in self management over the time they received individual support, with their accounts suggesting three key stages in that journey: 'Working with healthcare professionals'; 'Growing sense of responsibility'; and, 'Taking control'. Whilst all portrayed themselves as changed, participants' progress through those stages varied; a few continued to depend heavily on DAFNEplus facilitators for advice and/or direction at 12 months. Conclusions: While all participants benefited from individual support, our findings suggest that some may need, or gain further benefit from, longer‐term, tailored support. This has important implications for decision‐making about roll‐out of DAFNEplus post‐trial and for the development of future programmes seeking to bring about sustainable changes in self management practices. [ABSTRACT FROM AUTHOR]

Although reentry programming has grown, little is known about the process of developing reentry programming that utilizes peer support. Peer support is commonly utilized along side evidence-based practices in other service delivery areas (e.g., mental health), and is increasingly used during reentry, yet little is known about whether this practice is effective at reducing recidivism. This study examines a Smart Reentry program in an urban, Midwestern city. Drawing on 18 interviews with peer guides and family support specialists across two time points, and program participants at one time point, the authors examine the challenges and strengths related to staff training and development, program culture, and participant engagement. Results demonstrate the strengths of a family-centered model of reentry programing, and the challenges of working with the department of correction staff and paraprofessional peer guides within a professional environment. Suggestions are offered for programming utilizing similar models of paraprofessionals. [ABSTRACT FROM AUTHOR]

Background: Unnecessary antibiotic prescriptions in primary care are common and contribute to antimicrobial resistance in the population. Audit and feedback (A&F) on antibiotic prescribing to primary care can improve the appropriateness of antibiotic prescribing, but the optimal approach is uncertain. We performed two pragmatic randomized controlled trials of different approaches to audit and feedback. The trial results showed that A&F was associated with significantly reducing antibiotic prescribing. Still, the effect size was small, and the modifications to the A&F interventions tested in the trials were not associated with any change. Herein, we report a theory-informed qualitative process evaluation to explore potential mechanisms underlying the observed effects. Methods: Ontario family physicians in the intervention arms of both trials who were sent A&F letters were invited for one-on-one interviews. Purposive sampling was used to seek variation across interested participants in personal and practice characteristics. Qualitative analysis utilized inductive and deductive techniques informed by the Clinical Performance Feedback Intervention Theory. Results: Modifications to the intervention design tested in the trial did not alter prescribing patterns beyond the changes made in response to the A&F overall for various reasons. Change in antibiotic prescribing in response to A&F depended on whether it led to the formation of specific intentions and whether those intentions translated to particular behaviours. Those without intentions to change tended to feel that their unique clinical context was not represented in the A&F. Those with intentions but without specific actions taken tended to express a lack of self-efficacy for avoiding a prescription in contexts with time constraints and/or without an ongoing patient relationship. Many participants noted that compared to overall prescribing, A&F on antibiotic prescription duration was perceived as new information and easily actionable. Conclusion: Our findings indicate that contextual factors, including the types of patients and the setting where they are seen, affect how clinicians react to audit and feedback. These results suggest a need to test tailored feedback reports that reflect the context of how, where, and why physicians prescribe antibiotics so that they might be perceived as more personal and more actionable. Trial registration: Clinical Trial registration IDs: NCT04594200, NCT05044052. [ABSTRACT FROM AUTHOR]

Background: Community health workers (CHWs) remain an underutilized resource in social risk diagnostics in the primary care setting. This process evaluation study seeks to assess the role of CHWs in social risk screening, referral, and follow-up through process mapping to identify barriers to the process for future quality improvement efforts. Methods: Researchers at the Arizona Prevention Research Center (AzPRC) engaged with two Federally Qualified Health Centers (FQHCs) in two of Arizona's major urban areas to evaluate their internal processes for social risk screening and intervention. The Consolidated Framework for Implementation Research (CFIR) was used to direct a process mapping exercise to visually describe the workflow, gaps, and barriers to identifying and addressing social risk. Results: The process unveiled key areas for health system improvements in the community setting, the organizational setting, and in the implementation of social risk screening, referral, and follow-up. Further, process maps highlight the potential resources needed for effective CHW integration to address social risk in the primary care setting. Conclusions: Our findings demonstrate the importance of organizational tools, such as process mapping, to assist primary care settings in evaluating internal processes for quality improvement in addressing social risk and in effectively integrating the CHW workforce. Subsequent research will evaluate rates of social risk screening, referral, and follow-up within all of Arizona's FQHCs and propose models for CHW integration to address social risk in primary care and strengthen social risk screening reach and effectiveness. [ABSTRACT FROM AUTHOR]

Introduction: The fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4) is a large-scale, multicenter, prospective, randomized, open-label, blinded endpoint assessment trial, initiated in an ambulance in China, aiming at evaluating the effectiveness and safety of prehospital blood pressure (BP) lowering in patients with suspected acute stroke and elevated BP. A prespecified process evaluation is intended to explore the implementation of the trial intervention, provide support to interpret the trial outcomes and put forward suggestions to scale up the intervention in broader settings in the future. Methods: This process evaluation is a mixed-methods design, and follows the Normalization Process Theory (NPT) and the UK Medical Research Council (UK MRC) guidance. Fidelity, reach, acceptability, appropriateness, adoption, sustainability, and relevant contextual factors and mechanisms affecting the implementation of prehospital early intensive BP-lowering treatment will be analyzed. Semi-structured interviews with ambulance staff, ward and emergency department clinicians, and nurses are undertaken to explore perceptions of the intervention, contextual factors, and potential suggestions for future implementation in practice. Data from observational records, surveys, conventional monitoring data, on-site records, and case report forms will be analyzed to understand background care and context. Conclusion: The process evaluation of INTERACT4 will provide insights for the implementation of prehospital early intensive BP-lowering intervention in different health systems and help better explain the trial results for further scale up. [ABSTRACT FROM AUTHOR]

Background: The positive effects of regular physical activity on children and adolescents' physical and mental health are well-established. Despite these health benefits, most Swiss adolescents do not meet WHO's recommended level of physical activity, which includes a daily minimum of 60 min of moderate-to-vigorous physical activity. Due to their inclusivity, schools are identified as a key setting to promote physical activity. Recently, the comprehensive school physical activity program (CSPAP), in which teachers as physical activity leaders (PALs) play a crucial role to advance comprehensive school-based physical activity promotion, has been discussed. However, such comprehensive approaches are still lacking in Switzerland, and specific PAL trainings do not exist. Therefore, the aim of this study is to implement and evaluate Active School, a comprehensive school-based physical activity program for Swiss secondary schools with integrated PAL training. Methods/design: A cluster randomized controlled trial (RCT) involving 12 secondary schools (6 experimental, 6 waiting control schools) will assess baseline data and effectiveness of Active School at 12 and 24 months. Active School includes five components based on the CSPAP. Each school is encouraged to set individual physical activity goals in this regard. This process is guided by the PALs, who will participate in professional development training before and during Active School implementation. As a primary outcome, students' moderate-to-vigorous physical activity will be assessed via accelerometers. As secondary outcomes, inactivity, light physical activity, step counts, aerobic fitness and coordination will be measured, and students' general wellbeing, learning behavior, and multiple psychosocial measures related to physical activity will be assessed by questionnaires. The effectiveness evaluation is accompanied by a process evaluation that focuses on the implementation outcomes of dose of delivery, reach, feasibility, and sustainability. A mixed methods approach, including ripple effect mapping, will be employed to reconstruct and understand the implementation process. Discussion: This study will be the first to implement and evaluate a CSPAP in the Swiss school system. The specific PAL training and the simultaneous application of effectiveness and process evaluation are considered strengths of the study. Trial registration: German Clinical Trials Register (DRKS00033362). Date of registration: January 25, 2024. Retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: The National Institute for Health and Care Excellence (NICE) recommend that men with prostate cancer on androgen deprivation therapy (ADT) are offered twice weekly supervised aerobic and resistance exercise to address side effects of treatment. However, supervised exercise is not routinely offered in standard clinical practice. The STAMINA programme grant for applied research (PGfAR) has been designed to evaluate whether this recommendation can be delivered within standard NHS care. This paper describes how future implementation of NICE recommendations within the NHS was explored during complex intervention development to enable evaluation of a lifestyle intervention. Methods: Two stakeholder workshops were conducted to explore factors pertinent to future implementation of the STAMINA Lifestyle intervention (SLI). Normalisation Process Theory (NPT) provided the theoretical framework for discussion and analysis. Stakeholder workshop 1 focussed on intervention coherence and buy-in. Stakeholder workshop 2 explored barriers and facilitators for embedding SLI into the context of the NHS, with delivery partner Nuffield Health, in the future. Results: Workshops were attended by healthcare professionals (n = 16), exercise professionals (n = 17), members of public involved in PPI including patients (n = 12), health psychologists (n = 2), clinical commissioners (n = 4), cancer charities (n = 3), a cancer alliance (n = 1) and health economist (n = 1). Stakeholders agreed that professional training packages should emphasise the uniqueness of the SLI and underpinning theory and evidence (Coherence). To further engagement, the use of STAMINA champions and information about the delivery partner were recommended to enhance confidence and knowledge (Cognitive participation). Furthermore, a simple communication (Collective Action) and progress reporting system (Reflexive Monitoring) was suggested to fit into existing infrastructure within the NHS and community partner. Conclusions: Application of NPT within two stakeholder workshops enhanced complex intervention development. Context-specific strategies to support implementation of SLI within the context of a trial were proposed, sensed-checked, and considered acceptable. The organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out were considered (if proven to be effective) and will be explored in the qualitative component of a process evaluation underpinned by NPT. Trial registration: (ISRCTN: 46385239). Registered on July 30, 2020. [ABSTRACT FROM AUTHOR]

Objective: Participatory organizational-level interventions carry a risk of implementation failure. The current study evaluates the implementation of a work stress prevention approach in primary education and reflects on the use of realtime feedback as implementation strategy to prevent this risk. Methods: The process evaluation was conducted at four primary schools in the Netherlands. A framework for evaluating organizational-level interventions was applied using mixed methods. Results: Results show the implementation level varied between schools and was hindered by the intervention context, school size, and planning of the approach. Management commitment and employee involvement seemed important factors for successful implementation. Real-time feedback seemed valuable to further improve implementation, but not to prevent implementation failure. Conclusions: Collecting data on implementation factors before the active phase of the approach, may provide the possibility to anticipate on implementation problems earlier. [ABSTRACT FROM AUTHOR]

Recent technological advancements are transforming the architecture, engineering and construction (AEC) industry, focusing on digitalization and automation opportunities as drivers for improvement. In a realm as complex as building permitting, the drive for automation should be anchored in a comprehensive understanding of the process it seeks to transform. Furthermore, analyzing the process from a global perspective is essential for identifying opportunities for improvement. This article addresses the need for a systematic and robust approach to evaluate and compare building permit processes globally. Traditional approaches for process comparisons fail to capture the intricacies of a building permit process. Hence, in this paper, the authors propose and introduce the Process Analysis and Comparative Evaluation methodology, PACE-BP, which was tailored for building permit processes. The proposed method relies on a previously developed framework for process mapping which provides a comparable data set of building permit process maps in different countries. The comparative evaluation is then performed by assessing the maps based on predefined indicators, which are used to compile a representative vector for each process. The computational method for compiling the vectors and calculating the similarity measures between pairs of processes is described in detail. The application of PACE-BP for analyzing and comparing building permit processes in Germany, the US, Israel, and Italy is demonstrated in this paper. Our findings challenge the pursuit of a universal "best practice," emphasizing the need to balance priorities and stakeholder's objectives. The PACE-BP method is a powerful tool for policymakers and stakeholders, providing meaningful insight into existing processes and pinpointing drawbacks and limitations in current practices, while revealing opportunities for improvement. [ABSTRACT FROM AUTHOR]

Background: Stepping Stones Triple P (SSTP) is a complex parent‐mediated intervention aimed to reduce behaviours that challenge in children with moderate to severe intellectual disabilities, aged 30–59 months. Methods: To formulate a comprehensive understanding of SSTP implementation in the UK, we conducted a process evaluation collecting stakeholder views and considering intervention fidelity, dose, reach, delivery adaptations, and acceptability. Results: Fidelity and quality of delivery ratings were high. Parents perceived SSTP as valuable, reporting increased parental confidence and understanding of the child's behaviours. However, only 30% of families received an adequate dose of the intervention. Parents who only received treatment as usual described feeling abandoned by current services. Service managers emphasised the importance of availability of resources and therapist training for successful intervention delivery. Conclusions: SSTP supports effective management of early‐onset behaviours that challenge. Further work is needed to ensure equitable access to the intervention across health and social care services. Trial Registration: NCT03086876 – https://www.clinicaltrials.gov/ct2/show/NCT03086876?term=Hassiotis+Angela&draw=1&rank=1. [ABSTRACT FROM AUTHOR]

Objective: To conduct a systematic review of process evaluations (PEs) of diabetes self-management programs (DSMPs). Data Source: An electronic search using Medline (Ovid), Embase (Ovid), CINAHL (Ensco), Academic Search (Ebsco), and APA PsycInfo (Ebsco). Study Inclusion and Exclusion Criteria: Peer-reviewed, empirical quantitative, qualitative, or mixed-method studies were included if they (1) were a traditional, group-based DSMP, (2) involved adults at least 18 years with T1DM or T2DM, (3) were a stand-alone or embedded PE, and (4) published in English. Data Extraction: The following process evaluation outcomes were extracted: fidelity, dose delivered, dose received, reach, recruitment, retention, and context. Additional items were extracted, (eg, process evaluation type, data collection methods; theories; frameworks or conceptual models used to guide the process evaluation, and etc). Data Synthesis: Due to heterogeneity across studies, studies were synthesized qualitatively (narratively). Results: Sixty-eight studies (k) in 78 articles (n) (k = 68; n = 78) were included. Most were mixed methods of low quality. Studies were typically integrated into outcome evaluations vs being stand-alone, lacked theoretical approaches to guide them, and incorporated limited outcomes such as dose received, reach, and retention. Conclusion: Future research should 1) implement stand-alone theoretically grounded PE studies and 2) provide a shared understanding of standardized guidelines to conduct PEs. This will allow public health practitioners and researchers to assess and compare the quality of different programs to be implemented. [ABSTRACT FROM AUTHOR]

Rationale: To ensure optimal patient care based on evidence, it is crucial to understand how to implement new methods in practice. However, intervention studies often overlook parts of the implementation process. A comprehensive process evaluation is necessary to understand why interventions succeed or fail in specific contexts and to integrate new knowledge into daily practice. This evaluation examines the full implementation of the Co‐Work‐Care model in Swedish primary healthcare to identify strengths and weaknesses. Aim: This study aimed to evaluate the process of implementing the CO‐WORK‐CARE model that focuses on close collaboration and the use of a person‐centred dialogue meeting in primary healthcare for patients on sick leave due to common mental disorders. Method: The CO‐WORK‐CARE model emphasises collaboration among the GP, rehabilitation coordinator and care manager, along with person‐centred dialogue meetings involving employers. Following UK Medical Research Council guidelines, we conducted a process evaluation. Data from previous studies were reanalysed. We also analysed field notes and meeting notes using Malterud's qualitative method. Results: The evaluation identified key facilitators for model implementation, including regular visits by facilitators and guidance from the research physician. Peer support meetings also bolstered implementation. However, challenges emerged due to conflicts with existing structures and limitations in person‐centred dialogue meetings. Conclusion: Adapting the CO‐WORK‐CARE model to Swedish primary care is feasible and beneficial, with collaboration among the care manager, rehabilitation coordinator and GP and person‐centred dialogue meetings. Thorough preparations, ongoing facilitator and peer support and integrated information enhanced implementation efficiency, despite challenges posed by existing structures. [ABSTRACT FROM AUTHOR]

Purpose: As the effect evaluation of our randomized controlled trial the "Comprehensive Approach of Reintegration for clients with Multiple problems" (CARm) showed no superior effect on re-integration into paid employment of the clients when compared with clients of the care as usual, we conducted this process evaluation to gain insight into whether the intervention was conducted according to protocol. Methods: Using questionnaires on recruitment, reach, dose delivered, dose received, fidelity, context, and satisfaction we collected data from 40 labour experts of the Public Employment Service of the Dutch Social Security Institute, and from 166 disability benefit recipients dealing with multiple problems. Results: Only few of the labour experts provided the key elements of the intervention to their clients. Between the clients of both groups were no significant differences in the dose received. More than half of the labour experts of the intervention group reported organizational changes. Conclusion: The lack of effect of the CARm intervention was almost certainly caused by implementation failure. Once again this study showed the importance of involving all stakeholders in developing and the conduct of the intervention, and of clarifying the consequences for the organization, to ensure that it can be conducted according to protocol. IMPLICATIONS FOR REHABILITATION: A Strength based intervention was developed to improve re-integration into paid employment of disability benefit recipients facing multiple problems and a process evaluation was carried out. Organizations should provide sufficient time to support their professionals by implementing this intervention into practice. Protocol adherence is crucial to value intervention results in practice. [ABSTRACT FROM AUTHOR]

Native Americans (NA) have higher obesity rates compared to other populations. Employed adults spend a significant amount of time at work. OPREVENT2, an obesity prevention trial in 6 NA communities, included a worksite component that incorporated nutrition and physical activity educational media, competitions, tastes tests, and coffee station makeovers. Process evaluation results indicate a well-implemented worksite component based on team standards. Statistically significant improvements of coffee stations healthy offerings (p =.006), but none in health policies and resources, were observed. Partnering with businesses to create healthier working environments was successful and future trials should investigate the effects on an individual level. [ABSTRACT FROM AUTHOR]

Abstract Background Musculoskeletal disorders are commonly treated in primary healthcare and may, if not treated adequately, entail a risk for long-term disability and sickness absence. A team-based rehabilitation intervention (PREVention of Sickness Absence for Musculoskeletal disorders, PREVSAM) was evaluated in a randomised controlled trial. The purpose of this study was to evaluate the process of implementing the PREVSAM model in primary care rehabilitation. Methods This process evaluation was conducted alongside the trial, collecting quantitative and qualitative data to evaluate how the PREVSAM model was implemented, mechanisms of impact, and contextual factors. Acceptability, feasibility, appropriateness, adaptations, training and support, resources, recruitment, reach, retention, dose, fidelity, and readiness for change were investigated. Qualitative data were collected from healthcare professionals and patients. Results Eight of 22 invited rehabilitation clinics (36%) and 28 of 54 healthcare professionals (52%) were included in the PREVSAM trial and this process evaluation. Of 507 eligible patients, 261 (51%) were included. Of those, 134 were randomised to the intervention and 129 (96%) were retained. Twelve healthcare professionals and 15 patients participated in the qualitative evaluations. The model’s essential components; individual assessments and structured, team-based rehabilitation with clear division of responsibilities agreed in a joint health plan; were generally delivered according to protocol. The optional components early access to psychological treatment and workplace contact were delivered to a lesser extent. Perceived acceptability, feasibility, and appropriateness of the PREVSAM model were moderate to high. Several contextual barriers, in the form of missing prerequisites, affected the implementation. Qualitative data showed that the model, with its holistic view, was appreciated by both healthcare professionals and patients. Conclusions This process evaluation suggests that PREVSAM is acceptable, feasible and appropriate for patients with MSDs reporting psychological risk factors associated with increased risk for sickness absence. While essential components were implemented with fidelity for most patients, optional components were not. This variability reflects the complexity of the model, its mandatory and optional components, contextual barriers, and the person-centred approach meeting individual patient needs. As all model components were not delivered to all patients, the intervention may have been too similar to treatment as usual to detect differences on a group level. A limitation of the study is that half of the participating rehabilitation clinics withdrew prematurely.

Abstract Background The transition from pediatric to adult care is a vulnerable time for young people living with type 1 diabetes (T1D). Bridging the Gap (BTG) is an audit-and-feedback (AF) intervention aimed at improving both transitions-in-care processes and diabetes management in the year following transition. As part of BTG, we conducted a qualitative process evaluation to understand: (a) what was implemented and how; and (b) the contextual factors (micro-, meso- and macro-) that affected implementation, outcomes and study processes. Methods Using qualitative descriptive methodology, interviews were conducted with 13 healthcare professionals (HCPs) delivering diabetes care to transitioning youth. Participants were asked about their experiences of BTG study processes and feedback tools, the quality improvement (QI) initiatives implemented at their site, and potential spread and scale. Interviews also explored the impacts of COVID-19 on transition care and study processes and results. Results Five key themes were identified. Participants’ reflections on the BTG study design indicated they appreciated its flexible, site-specific approach to QI, which they saw as crucial to the success of their initiatives. Engagement with feedback reports and other study resources provided comparative, site-specific data. Participants described the challenges posed by the COVID-19 pandemic and its impacts on patients, care provision and study implementation. Their site-specific QI initiatives resulted in changes to their transition practices. Finally, participants commented on how BTG and its processes fostered a community of practice (CoP) between sites, resulting in new opportunities to collaborate and share experiences. Conclusions BTG resulted in a CoP among practitioners delivering transition care to youth with T1D, which could be scaled up to promote a learning health system in pediatric diabetes care. Qualitative process evaluation is a useful tool for understanding how contextual factors affect the implementation and outcomes of complex QI interventions.

Abstract Background We previously performed a pragmatic cluster randomized controlled trial (RCT) in general practices and older adult care organizations in Poland, the Netherlands, Norway, and Sweden. We found that a multifaceted antibiotic stewardship intervention (ASI) substantially reduced antibiotic use for suspected urinary tract infections (UTIs) in frail older adults compared with usual care. We aimed to evaluate the implementation process of the ASI to provide recommendations for clinical practice. Methods We conducted a process evaluation alongside the cluster RCT. The ASI consisted of a decision-tool and a toolbox, which were implemented using a participatory-action-research (PAR) approach with sessions for education and evaluation. We documented the implementation process of the intervention and administered a questionnaire to health care professionals (HCPs) from participating organizations in the intervention and usual care clusters. We evaluated the multiple components of the intervention and its implementation following a structured framework. Results The questionnaire was completed by 254 HCPs from the 38 participating clusters. All components were largely delivered according to plan and evaluated as useful. The decision-tool and toolbox materials were reported to facilitate decision-making on UTIs. Regarding the PAR approach, educational sessions focusing on the distinction between UTIs and asymptomatic bacteriuria were held in all 19 intervention clusters. In 17 out of these 19 clusters, evaluation sessions took place, which were reported to help remind HCPs to implement the ASI. During both sessions, HCPs valued the reflection that took place and the resulting awareness of their behavior. It allowed them to explore implementation barriers and to tailor their local implementation process to overcome these. For example, HCPs organized extra educational sessions or revised local policies to incorporate the use of the decision-tool. Various HCPs took key roles in implementation. Staff changes and the COVID-19 pandemic were important contextual barriers. Conclusions We found each component of the multifaceted ASI and its implementation to have added value in the process to improve antibiotic prescribing for suspected UTIs in a heterogeneous older adult care setting. We recommend using a multifaceted, multidisciplinary approach that enables HCPs to reflect on their current practice and accordingly tailor local implementation. Trial registration ClinicalTrials.gov NCT03970356. Registered on May 31, 2019.

Abstract Background Breastfeeding is a powerful public health intervention that produces long-term health benefits. However, in high-income countries such as Denmark, breastfeeding rates are suboptimal and unequally distributed across socio-economic positions. The ‘Breastfeeding – a good start together’ intervention, to promote longer duration of exclusive breastfeeding and reduce social inequity, was implemented in a cluster-randomised trial during 2022–2023 across 21 municipalities in two Danish regions. A process evaluation was conducted to assess the implementation, mechanisms of impact, and possible contextual factors affecting the intervention. Methods The study was guided by the Medical Research Council’s guidance for conducting process evaluations and employed a mixed-methods approach in a convergence design. Quantitative data: contextual mapping survey (n = 20), health visitor survey (n = 284), health visitor records from 20 clusters and intervention website statistics. Qualitative data: dialogue meetings (n = 7), focus groups (n = 3) and interviews (n = 8). Results Overall, the intervention was delivered as planned to intended recipients, with few exceptions. Health visitors responded positively to the intervention, noting that it fitted well within their usual practice and enhanced families’ chances of breastfeeding. Mothers expressed having received the intervention with few exceptions, and reacted positively to the intervention. Although health visitors were concerned about the potential stigmatisation of mothers receiving the intensified intervention, none of the interviewed mothers felt stigmatised. Contextual factors impacting the intervention implementation and mechanisms included staff and management turnover, project infrastructure and mothers’ context, such as resources, social networks and previous experiences. The overall fidelity of the intervention delivery was high. Conclusions Health visitors and families responded well to the intervention. Interventions aimed at enabling health care providers to deliver simplified and structured breastfeeding support, in alignment with support provided in other sectors of the health care system, may increase breastfeeding rates and reduce social inequity in breastfeeding, even in international contexts. Trial registration Clinical Trials: NCT05311631. First posted April 5, 2022.

Abstract Background Intermediate care (IC) services bridge the transition for older patients from the hospital to the home. Despite the goal of involving individuals in their recovery process, these services often become standardised, leading to communication breakdowns. While evidence-based practices, such as the Four Habits Model (4HM), for effective communication are crucial for enhancing high-quality healthcare, research suggests their integration into routine practice remains limited. In this study, we aimed to investigate the implementation process of the 4HM through a two-day course that engaged healthcare professionals and managers in IC. Methods We conducted a process evaluation employing qualitative and quantitative methods: (i) individual interviews with three managers and two course participants pre-course, (ii) two focus group interviews with course participants (N = 11) and individual interviews with the same three managers post-course, and (iii) the NoMAD questionnaire (Normalisation MeAsure Development) administered four months later to assess the short- and long-term impact on course participants (N = 14). Reflexive thematic analyses were guided by Normalisation Process Theory (NPT), which offers insight into how new interventions become routine practices. The analysis of the NoMAD involved descriptive statistics. Results We identified four themes in the qualitative data: (i) Decoding Interactions: Making Sense of the 4HM in IC services, (ii) Fostering Change: Legitimising 4HM Through Staff Engagement, (iii) Harmonising Practice: Integrating 4HM into Complex Situations, and (iv) Embedding Value: Normalising the 4HM into Everyday Work. These themes illustrate the normalisation process of the 4HM course within IC, establishing standard practices. Healthcare professionals and managers highlighted the urgent need to integrate communication skills based on the 4HM into daily care. They noted positive changes in their communication habits following the course. The consistent findings from the NoMAD questionnaire underscore the sustainability of implementing the 4HM programme, as participants continue to utilise it in their clinical practice beyond the initial four-month period. Conclusion The 4HM course programme was deemed feasible for expansion within IC services. Both managers and staff found its focus on addressing communication breakdowns and readiness for change sensible. The study findings may benefit the stakeholders involved in IC service routines, potentially improving services for older patients and relatives.

Abstract Background Most reviews of nutrition-sensitive programs assess the evidence base for nutrition outcomes without considering how programs were delivered. Process evaluations can fill this void by exploring how or why impacts were or were not achieved. This mid-term process evaluation examines a home garden intervention implemented in a large-scale, livelihoods improvement program in Odisha, India. The objectives are to understand whether the intervention was operating as planned (fidelity), investigate potential pathways to achieve greater impact, and provide insights to help design future home garden programs. Methodology Data collection and analysis for this theory-driven process evaluation are based on a program impact pathway that shows the flow of inputs, processes, outputs, outcomes, and impacts. Quantitative and qualitative data from focus group discussions, semi-structured interviews, and a Process Net-Mapping exercise with beneficiaries, frontline workers, and program management staff. Results Despite a mismatch between the design and implementation (low fidelity), the process evaluation identified positive outputs, outcomes, and impacts on home garden production, consumption, income, health and nutritional outcomes, and women’s empowerment. Flexibility led to greater positive outcomes on nutrition, the adoption of sustainable agricultural practices and easy-to-understand nutrition models, and the likelihood of the intervention being sustained after the program ends. Conclusions To help food systems in rural settings reduce food insecurity by utilizing more sustainable agricultural practices, we recommend that home garden interventions include instruction on easy-to-understand nutrition models and on how to make natural fertilizer. Finding local solutions like home gardens to help address critical supply issues and food insecurity is paramount.

Abstract Background Unnecessary antibiotic prescriptions in primary care are common and contribute to antimicrobial resistance in the population. Audit and feedback (A&F) on antibiotic prescribing to primary care can improve the appropriateness of antibiotic prescribing, but the optimal approach is uncertain. We performed two pragmatic randomized controlled trials of different approaches to audit and feedback. The trial results showed that A&F was associated with significantly reducing antibiotic prescribing. Still, the effect size was small, and the modifications to the A&F interventions tested in the trials were not associated with any change. Herein, we report a theory-informed qualitative process evaluation to explore potential mechanisms underlying the observed effects. Methods Ontario family physicians in the intervention arms of both trials who were sent A&F letters were invited for one-on-one interviews. Purposive sampling was used to seek variation across interested participants in personal and practice characteristics. Qualitative analysis utilized inductive and deductive techniques informed by the Clinical Performance Feedback Intervention Theory. Results Modifications to the intervention design tested in the trial did not alter prescribing patterns beyond the changes made in response to the A&F overall for various reasons. Change in antibiotic prescribing in response to A&F depended on whether it led to the formation of specific intentions and whether those intentions translated to particular behaviours. Those without intentions to change tended to feel that their unique clinical context was not represented in the A&F. Those with intentions but without specific actions taken tended to express a lack of self-efficacy for avoiding a prescription in contexts with time constraints and/or without an ongoing patient relationship. Many participants noted that compared to overall prescribing, A&F on antibiotic prescription duration was perceived as new information and easily actionable. Conclusion Our findings indicate that contextual factors, including the types of patients and the setting where they are seen, affect how clinicians react to audit and feedback. These results suggest a need to test tailored feedback reports that reflect the context of how, where, and why physicians prescribe antibiotics so that they might be perceived as more personal and more actionable. Trial registration Clinical Trial registration IDs: NCT04594200, NCT05044052.

Abstract Background Chronic diseases such as type 2 diabetes mellitus and coronary heart disease cause medical, social, and economic burdens worldwide. Disease management programs in Germany mostly lack components to improve patients’ self-management and health-promoting lifestyles despite clear guideline recommendations. Therefore, a Personalized Self-Management Support Program (P-SUP) was developed, which includes: (1) peer support groups; (2) telephone coaching; (3) feedback reports and, (4) a web portal. This study aims to explore patients’ and implementing stakeholders’ experiences in the implementation of P-SUP to identify barriers and facilitators to the implementation of the intervention. Methods A qualitative study was conducted using face-to-face focus group interviews with participating patients and telephone-based one-to-one expert interviews with implementing stakeholders, involved in the delivery of the intervention. The transcribed interview reports were analyzed using qualitative content analysis, and the contents were categorized according to Donabedian’s Structure-Process-Outcome framework. Results A total of six themes among patients (N = 35) and five themes among implementing stakeholders (N = 32) represent the experiences. The patient themes were: (1) technical conditions, (2) indoor facilities, (3) group composition, (4) acceptance of digital components, (5) supervision and feedback and (6) impact on lifestyle behavior. The themes among the implementing stakeholders were: (1) multiprofessional approach, (2) human resources, (3) patient acceptance, (4) supervision and feedback and (5) impact on lifestyle behavior. Conclusions Multiprofessional interventions such as P-SUP appear to be valuable for patients and implementing stakeholders. Although infrastructural barriers made the implementation of peer support and digital patient education difficult, patients rated the exchange with peers and experts on health-related topics positively. The lack of supervision and feedback during the course of the intervention might be compensated by regular telephone coaching. The findings from this study can be used in future studies to guide researchers and implementing stakeholders and to improve the feasibility and effectiveness of complex interventions in different contexts. Trial registration The P-SUP study was registered in the German Clinical Trials Register (DRKS) on 16/07/2020 under the registration number DRKS00020592.

Abstract Background Community health workers (CHWs) remain an underutilized resource in social risk diagnostics in the primary care setting. This process evaluation study seeks to assess the role of CHWs in social risk screening, referral, and follow-up through process mapping to identify barriers to the process for future quality improvement efforts. Methods Researchers at the Arizona Prevention Research Center (AzPRC) engaged with two Federally Qualified Health Centers (FQHCs) in two of Arizona’s major urban areas to evaluate their internal processes for social risk screening and intervention. The Consolidated Framework for Implementation Research (CFIR) was used to direct a process mapping exercise to visually describe the workflow, gaps, and barriers to identifying and addressing social risk. Results The process unveiled key areas for health system improvements in the community setting, the organizational setting, and in the implementation of social risk screening, referral, and follow-up. Further, process maps highlight the potential resources needed for effective CHW integration to address social risk in the primary care setting. Conclusions Our findings demonstrate the importance of organizational tools, such as process mapping, to assist primary care settings in evaluating internal processes for quality improvement in addressing social risk and in effectively integrating the CHW workforce. Subsequent research will evaluate rates of social risk screening, referral, and follow-up within all of Arizona’s FQHCs and propose models for CHW integration to address social risk in primary care and strengthen social risk screening reach and effectiveness.

Abstract Background The positive effects of regular physical activity on children and adolescents’ physical and mental health are well-established. Despite these health benefits, most Swiss adolescents do not meet WHO’s recommended level of physical activity, which includes a daily minimum of 60 min of moderate-to-vigorous physical activity. Due to their inclusivity, schools are identified as a key setting to promote physical activity. Recently, the comprehensive school physical activity program (CSPAP), in which teachers as physical activity leaders (PALs) play a crucial role to advance comprehensive school-based physical activity promotion, has been discussed. However, such comprehensive approaches are still lacking in Switzerland, and specific PAL trainings do not exist. Therefore, the aim of this study is to implement and evaluate Active School, a comprehensive school-based physical activity program for Swiss secondary schools with integrated PAL training. Methods/design A cluster randomized controlled trial (RCT) involving 12 secondary schools (6 experimental, 6 waiting control schools) will assess baseline data and effectiveness of Active School at 12 and 24 months. Active School includes five components based on the CSPAP. Each school is encouraged to set individual physical activity goals in this regard. This process is guided by the PALs, who will participate in professional development training before and during Active School implementation. As a primary outcome, students’ moderate-to-vigorous physical activity will be assessed via accelerometers. As secondary outcomes, inactivity, light physical activity, step counts, aerobic fitness and coordination will be measured, and students’ general wellbeing, learning behavior, and multiple psychosocial measures related to physical activity will be assessed by questionnaires. The effectiveness evaluation is accompanied by a process evaluation that focuses on the implementation outcomes of dose of delivery, reach, feasibility, and sustainability. A mixed methods approach, including ripple effect mapping, will be employed to reconstruct and understand the implementation process. Discussion This study will be the first to implement and evaluate a CSPAP in the Swiss school system. The specific PAL training and the simultaneous application of effectiveness and process evaluation are considered strengths of the study. Trial registration German Clinical Trials Register (DRKS00033362). Date of registration: January 25, 2024. Retrospectively registered.

Abstract Background Urinary incontinence (UI) negatively affects the well-being of women globally. Pelvic Floor Muscle Training (PFMT) is a complex intervention that aims to decrease UI symptoms. Information about how the multiple complex components involved in PFMT achieve and maintain the desired effect are rarely studied as a whole. The evidence base lacks data about how women experience PFMT over time and in the longer-term. This study explored women’s experiences of biofeedback-assisted PFMT and PFMT alone, to identify and understand what influenced self-reported adherence to PFMT, and UI outcomes over time. Methods This rigorous longitudinal qualitative case study, nested within a randomised controlled trial, recruited forty cases (women with stress or mixed UI; 20 in biofeedback-assisted and 20 in PFMT alone group). A case included up to four semi-structured interviews with each woman (prior to starting PFMT, end of treatment [6 months], 12 months, 24 months). Analysis followed case study analytic traditions, resulting in a Programme Theory about PFMT from the perspectives of women with UI. Findings The theory demonstrates factors that motivated women to seek UI treatment, and how these influenced long-term adherence. Therapists who delivered PFMT played a crucial role in supporting women to know how to undertake PFMT (to have capability). Some, but not all, women developed self-efficacy for PFMT. Where women did not have PFMT self-efficacy, adherence tended to be poor. When women had PFMT self-efficacy, the conditions to support adherence were present, but contextual factors could still intercede to inhibit adherence. The intercession of contextual factors was individual to a woman and her life, meaning any particular contextual factor had inconsistent influences on PFMT adherence over time for individual women and exerted varying influences across different women. Conclusion Long term adherence to PFMT is a complex interaction between many different factors. Enquiring about an individual woman’s motivation to seek treatment and understanding the contextual factors that affect an individual woman will enable a practitioner to support longer-term adherence.

Abstract Background Healing Right Way (HRW) aimed to improve health outcomes for Aboriginal Australians with stroke or traumatic brain injury by facilitating system-level access to culturally secure rehabilitation services. Using a stepped-wedge randomised controlled trial (RCT) design (ACTRN12618000139279, 30/01/2018), a two-pronged intervention was introduced in four rural and four urban hospitals, comprising 1.Cultural security training (CST) for staff and 2.Training/employment of Aboriginal Brain Injury Coordinators (ABIC) to support Aboriginal patients for 6-months post-injury. Three-quarters of recruited patients lived rurally. The main outcome measure was quality-of-life, with secondary outcomes including functional measures, minimum processes of care (MPC); number rehabilitation occasions of service received, and improved hospital experience. Assessments were undertaken at baseline, 12- and 26-weeks post-injury. Only MPCs and hospital experience were found to improve among intervention patients. We report on the process evaluation aiming to support interpretation and translation of results. Methods Using mixed methods, the evaluation design was informed by the Consolidated Framework for Implementation Research. Data sources included minutes, project logs, surveys, semi-structured interviews, and observations. Four evaluation questions provided a basis for systematic determination of the quality of the trial. Findings from separate sources were combined to synthesise the emerging themes that addressed the evaluation questions. Three components were considered separately: the trial process, CST and ABIC. Results The complex HRW trial was implemented to a satisfactory level despite challenging setting factors, particularly rural–urban system dynamics. Patient recruitment constraints could not be overcome. The vulnerability of stepped-wedge designs to time effects influenced recruitment and trial results, due to COVID. Despite relatively high follow-up, including to rural/remote areas, data points were reduced. The lack of culturally appropriate assessment tools influenced the quality/completeness of assessment data. The ABIC role was deemed feasible and well-received. The CST involved complex logistics, but rated highly although online components were often incomplete. Project management was responsive to staff, patients and setting factors. Conclusions Despite mostly equivocal results, the ABIC role was feasible within mainstream hospitals and the CST was highly valued. Learnings will help build robust state-wide models of culturally secure rehabilitation for Aboriginal people after brain injury, including MPC, workforce, training and follow-up.

Abstract Background An mHealth-based school health education platform (EduSaltS) was promoted in real-world China to reduce salt intake among children and their families. This progress evaluation explores its implementation process and influencing factors using mixed methods. Methods The mixed-methods process evaluation employed the RE-AIM framework. Quantitative data were collected from a management website monitoring 54,435 third-grade students across two cities. Questionnaire surveys (n = 27,542) assessed pre- and post-education effectiveness. Mixed-effects models were used to control cluster effects. Qualitative interviews (23 individuals and 8 focus groups) identified program performance, facilitators, and barriers. Findings were triangulated using the RE-AIM framework. Results The program achieved 100% participation among all the third-grade classes of the 208 invited primary schools, with a 97.7% registration rate among all the 54,435 families, indicating high "Reach." Qualitative interviews revealed positive engagement from children and parents through the "small hands leading big hands" strategy. The high completion rate of 84.9% for each health cloud lesson and the significant improvement in salt reduction knowledge and behaviors scores from 75.0 (95%CI: 74.7–75.3) to 80.9 (95%CI: 80.6–81.2) out of 100 demonstrated the "Effect" of EduSaltS. The program's "Adoption" and "Implementation" were supported by attractive materials, reduced workload via auto-delivered lessons/activities and performance evaluation, and high fidelity to recommended activities, with medians 3.0 (IQR: 2.0–8.0)/class and 9.0 (IQR: 5.0–14.0)/school. Stable course completion rates (79.4%-93.4%) over one year indicated promising "Maintenance." Apart from the facilitating features praised by the interviewees, government support was the basis for the scaling up of EduSaltS. Barriers included the lack of smartphone skills among some parents and competing priorities for schools. Unhealthy off-campus environments, such as excessive use of salt in pre-packaged and restaurant foods, also hindered salt reduction efforts. The program's scalability was evident through its integration into existing health education, engagement of local governments and adaptation across various mobile devices. Conclusions The mHealth-based school health education program is scalable and effective for public salt reduction in China. Identified barriers and facilitators can inform future health program scale-ups. The program's successful implementation demonstrates its potential for broader application in public health initiatives aimed at reducing dietary salt intake.

Abstract Background In the UK, recent evidence of young people and gambling indicates a higher prevalence of gambling in comparison to other addictive behaviours. Engaging in gambling-related behaviour at a young age is associated with short and long-term consequences, including financial, emotional, academic, interpersonal, and physical and mental health detriments; otherwise known as gambling-related harms (GRH). Given the unique vulnerability of this younger group, early interventions aimed at delaying or preventing gambling are critical. PRoGRAM-A (Preventing Gambling-Related Harm in Adolescents) is a school-based, social network intervention to protect young people from future GRH, by delaying or preventing gambling experimentation. Methods Pilot cluster RCT with an embedded process evaluation and health economic scoping study. Participants PRoGRAM-A will be delivered in four schools, with two control schools acting as a comparator. All are secondary schools in Scotland. Baseline surveys were conducted with students in S3 (ages 13–14). Follow-up surveys were conducted with the same cohort, six months post-baseline. Intervention PRoGRAM-A trainers will deliver a 2-day, out-of-school training workshop to Peer supporters. Peer supporters will be nominated by peers among their school year group (S3, age 13–14). Workshops will provide peer supporters with information on four gambling-related topics: (1) what is gambling? (2) gambling and gaming, (3) gambling marketing, (4) identifying harm and reducing risk. Peer supporters will disseminate the information (message diffusion) they have learned among their friends and family over a 10-week period. After the 2-day workshop, PRoGRAM-A trainers will conduct × 3 in-school follow-up sessions with peer supporters to offer support, encouragement, and advice to Peer Supporters as well as monitor and explore the extent of their message diffusion. Primary outcome The primary outcome of the pilot cluster RCT (cRCT) will be whether progression to a phase III RCT is justified. Discussion This will be the first pilot cluster RCT (cRCT) of an intervention to prevent gambling-related harms among young people within the UK. If findings indicate feasibility and acceptability, funding will be sought for a phase III RCT of effectiveness. Trial registration Researchregistry8699. Registered 21st February 2023.

Abstract Background The number of surgical trials is increasing but such trials can be complex to deliver and pose specific challenges. A multi-centre, Phase III, RCT comparing Posterior Cervical Foraminotomy versus Anterior Cervical Discectomy and Fusion in the Treatment of Cervical Brachialgia (FORVAD Trial) was unable to recruit to target. A rapid qualitative study was conducted during trial closedown to understand the experiences of healthcare professionals who participated in the FORVAD Trial, with the aim of informing future research in this area. Methods Semi-structured interviews were conducted with 18 healthcare professionals who had participated in the FORVAD Trial. Interviews explored participants’ experiences of the FORVAD trial. A rapid qualitative analysis was conducted, informed by Normalisation Process Theory. Results Four main themes were generated in the data analysis: (1) individual vs. community equipoise; (2) trial set-up and delivery; (3) identifying and approaching patients; and (4) timing of randomisation. The objectives of the FORVAD trial made sense to participants and they supported the idea that there was clinical or collective equipoise regarding the two FORVAD interventions; however, many surgeons had treatment preferences and lacked individual equipoise. The site which had most recruitment success had adopted a more structured process for identification and recruitment of patients, whereas other sites that adopted more “ad hoc” screening strategies struggled to identify patients. Randomisation on the day of surgery caused both medico-legal and practical concerns at some sites. Conclusions Organisation and implementation of a surgical trial in neurosurgery is complex and presents many challenges. Sites often reported low recruitment and discussed the logistical issues of conducting a complex surgical RCT. Future trials in neurosurgery may need to offer more flexibility and time during set-up to maximise opportunities for larger recruitment numbers. Rapid qualitative analysis informed by Normalisation Process Theory was able to quickly identify key issues with trial implementation so rapid qualitative analysis may be a useful approach for teams conducting qualitative research in trials. Trial registration ISRCTN, ISRCTN reference: 10,133,661. Registered 23rd November 2018.

Abstract Background This study demonstrates how formative process evaluation was used to assess implementation and improve dose and fidelity in the Together Everyone Achieves More Physical Activity (TEAM-PA) randomized controlled trial. TEAM-PA uses a randomized group cohort design to evaluate the efficacy of a group-based intervention for increasing physical activity among African American women. Methods Intervention groups met for 10 weeks and were co-led by female African American facilitators, with intervention sessions consisting of group feedback, a health curriculum, group-based physical activity games, and group-based goal-setting. Drawing from a multi-theoretical framework, the intervention targeted social affiliation using collaborative and competitive group strategies, including essential elements focused on group-based behavioral skills, peer-to-peer positive communication, collectivism, optimal challenge, social facilitation, and peer to peer challenges. Formative process evaluation was used to monitor reach, dose, and fidelity, and implement feedback and solutions. Results Across two cohorts, four groups (n = 54) were randomized to the TEAM-PA intervention. On average 84.8% of participants attended each week, which exceeded the a priori criteria. Results from the systematic observations indicated that on average 93% of the dose items were completed in each session and adequate levels of fidelity were achieved at both the facilitator and group-levels. Participants were compliant with wearing the FitBits (6.73 ± 0.42 days/week) and most participants successfully contributed to meeting the group-based goals. The use of open-ended items also revealed the need for additional modifications to the group-based PA games, including allowing for individuals to take breaks, incorporating a broader range of exercises, minimizing activities that required bending/reaching down without assistance, and providing facilitators with additional training for implementing the games. Initial evidence suggests that these changes were successful in increasing participants’ comprehension of the games from Cohort 1 (M = 1.83, SD = 0.71) to Cohort 2 (M = 3.33, SD = 0.69). Conclusion Findings from this study demonstrated high levels of reach, dose, and fidelity, while also highlighting strategies for implementing competitive group-based PA games that are accessible across physical fitness levels. Formative process evaluation, including open-ended items and collaborative brainstorming, holds tremendous potential for improving future interventions. Trial registration This study was registered on Clinicaltrials.gov (# NCT05519696) on August 22, 2022 prior to the enrollment of the first participant on September 12, 2022 ( https://clinicaltrials.gov/study/NCT05519696?term=NCT05519696&rank=1 ).

Abstract Background Comprehensive sexuality education (CSE) is critical in addressing negative sexual and reproductive health (SRH) outcomes among adolescents. Yet in many low- and middle-income countries (LMICs) including Zambia, little is known about the impact, realities of CSE implementation, the quality of teaching and the comprehensiveness of the content covered. Methods Our approach was informed by a process evaluation incorporating recommendations by the European Expert Group guidance on evaluating sexuality education programmes and the Medical Research Council (MRC) guidelines on process evaluation. The development process and quality of CSE implementation were assessed using eight and six quality criteria respectively. In-depth interviews (IDIs), focus group discussions (FGDs), document analysis and classroom observation were employed to assess contextual factors, implementation process and mechanisms of impact of CSE. In-depth interviews (50) and focus group discussions (2) with seven pupils in each group were conducted among 64 purposefully selected participants. The sample comprised pupils (35), parents (4) and teachers (17) from nine secondary schools (four peri-urban, four urban and one rural), policymakers (4), and religious leaders (4). We employed deductive content analysis to analyse the data. Results Contextual factors that influenced the implementation of CSE included: (1) piecemeal funding for the CSE programme; (2) lack of monitoring programmes in schools; (3) lack of community engagement; (4) religious and socio-cultural barriers; (5) lack of skills and competency to teach CSE; and (6) insufficient time allocation for CSE. The assessment of the quality of the development of CSE revealed: (1) a lack of sexual diversity; (2) no meaningful participation of pupils in programme implementation; (3) a lack of stakeholder engagement during programme implementation; (4) lack of gender sensitivity; and (5) lack of human rights approach. Assessment of the quality of the implementation of CSE revealed: (1) no evidence of skill-based CSE teaching; (2) no linkage between CSE and SRH services in the communities; and (3) a lack of incorporation of multiple delivery methods during CSE teaching. The mechanisms of impact of CSE were related to the acceptability and positive changes in pupils’ SRH practices. Conclusion The complex influences of contextual factors during CSE implementation highlight the need for contextual analysis during the interventional design. Co-creation of the CSE programme through stakeholder participation could reduce social opposition and enable a culturally sensitive CSE. Comprehensive teacher training, a guiding curriculum as well as setting of appropriate monitoring tools and indicators are likely to enhance the quality of CSE implementation.

Abstract Background POINCARE-2 trial aimed to assess the effectiveness of a strategy designed to tackle fluid overload through daily weighing and subsequent administration of treatments in critically ill patients. Even in highly standardized care settings, such as intensive care units, effectiveness of such a complex intervention depends on its actual efficacy but also on the extent of its implementation. Using a process evaluation, we aimed to provide understanding of the implementation, context, and mechanisms of change of POINCARE-2 strategy during the trial, to gain insight on its effectiveness and inform the decision regarding the dissemination of the intervention. Methods We conducted a mixed-method process evaluation following the Medical Research Council guideline. Both quantitative data derived from the trial, and qualitative data from semi-structured interviews with professionals were used to explain implementation, mechanisms of change of the POINCARE-2 strategy, as well as contextual factors potentially influencing implementation of the strategy. Results Score of actual exposure to the strategy ranged from 29.1 to 68.2% during the control period, and from 61.9 to 92.3% during the intervention period, suggesting both potential contamination and suboptimal fidelity to the strategy. Lack of appropriate weighing devices, lack of human resources dedicated to research, pre-trial rooted prescription habits, and anticipated knowledge of the strategy have been identified as the main barriers to optimal implementation of the strategy in the trial context. Conclusions Both contamination and suboptimal fidelity to POINCARE-2 strategy raised concerns about a potential bias towards the null of intention-to-treat (ITT) analyses. However, optimal fidelity seemed reachable. Consequently, a clinical strategy should not be rejected solely on the basis of the negativity of ITT analyses’ results. Our findings showed that, even in highly standardized care conditions, the implementation of clinical strategies may be hindered by numerous contextual factors, which demonstrates the critical importance of assessing the viability of an intervention, prior to any evaluation of its effectiveness. Trial registration Number NCT02765009

Abstract Background Falls among older adults represent a major health hazard across the world. In 2022, the World Falls Guidelines was published, summarising research evidence and expert recommendations on how to prevent falls, but we need more knowledge on how the evidence can be successfully implemented into routine practice. In this study we used an implementation strategy co-created by healthcare providers, older adults who had fallen and researchers, to facilitate uptake of fall prevention recommendations. This current study aimed to evaluate the feasibility of this co-created implementation strategy in homecare services and provide information on the intervention and measurements for a full-scale cluster-randomized trial. Methods This study was a single-armed feasibility study with an embedded mixed-method approach completed in two city districts of Oslo, Norway, over a period of ten weeks. The co-created implementation strategy consists of a package for implementing national recommendations for preventing falls, empowering leaders to facilitate implementation, establish implementation teams, competence improvement and implementation support. City districts established implementation teams who were responsible for the implementation. Feasibility was assessed both qualitatively and quantitatively, using focus group interviews with implementation team members and individual interviews with leaders and staff members and the Feasibility of Intervention Measure (FIM). Qualitative data were analysed using thematic analysis and the Normalisation Process Theory. Results Qualitative data were collected from 19 participants: 12 implementation team members, 2 leaders and 5 staff members. 8 of the implementation team members responded to FIM. The analysis revealed four themes: 1) Fostering consensus through tailored implementation and discussions on fall prevention, 2) The importance of multi-level and interdisciplinary collaboration in fall prevention implementation, 3) Minimizing perceived time usage through utilization of existing areas for implementation activities, and 4) Reflective monitoring demonstrates the importance of facilitation and structure in the implementation strategy. For FIM, there were a high level of agreement related to how implementable, possible, doable, and easy to use the implementation strategy was. Conclusions Overall, we found the implementation strategy to be feasible to enhance uptake of fall prevention recommendations in the Norwegian homecare services. To succeed with the implementation, a dedicated implementation team should receive support through the implementation process, they should choose small implementation activities to enhance fall prevention competence and managers should possess implementation knowledge. Trial registration The trial is registered in the Open Science Registry: https://doi.org/10.17605/OSF.IO/2JFHV Registered: January 11, 2023.

Abstract Background The assessment of the effectiveness of teaching interventions in enhancing students’ understanding of the Pharmaceutical Care Network Europe (PCNE) Classification System is crucial in pharmaceutical education. This is especially true in regions like China, where the integration of the PCNE system into undergraduate teaching is limited, despite its recognized benefits in addressing drug-related problems in clinical pharmacy practice. Therefore, this study aimed to evaluate the effectiveness of teaching interventions in improving students’ understanding of the PCNE Classification System in pharmaceutical education. Methods Undergraduate pharmacy students participated in a series of sessions focused on the PCNE system, including lectures (t1), case analyses (t2), and practical implementation (t3). The levels of understanding were evaluated using time-course questionnaires. Initially, paired samples t-Tests were used to compare understanding levels between different time points. Subsequently, Repeated Measures Analysis (RMA) was employed. Pearson correlation analysis was conducted to examine the relationship between understanding levels and the usability and likelihood of using the PCNE system, as reported in the questionnaires. Results The paired samples t-Tests indicated insignificant differences between t2 and t3, suggesting limited improvement following the practical implementation of the PCNE system. However, RMA revealed significant time effects on understanding levels in effective respondents and the focused subgroup without prior experience (random intercept models: all p

ABSTRACT Background. This study assessed fidelity and feasibility of the Self-Management of Well-being (SMW) intervention for long-term social assistance recipients (SARs). Methods. Next to evaluation forms and on-site observations, semi-structured interviews with participants and teachers were used, which were recorded and transcribed verbatim. Thematic analysis was performed using ATLAS.ti 23. Results. The intervention was executed with high fidelity, and seems feasible for the target population. Teachers and participants were positive about the intervention, its complexity, facilitation strategies, recruitment, quality of delivery, participant responsiveness, acceptability, and suitability. Participant dropout was relatively high. Discussion. This study contributes to improving the well-being of long-term SARs, as it provides an adequate support tool for this group. Drop-out remains a challenge. The positive results encourage widespread dissemination of the intervention. A study on its effectiveness is underway.

Abstract Background General practice is often recommended as an ideal setting to initiate advance care planning (ACP), but uptake of ACP in this setting is low. ACP-GP is a complex intervention to facilitate ACP for patients with chronic, life-limiting illness in Belgian general practice. It aims to increase patient ACP engagement and general practitioner (GP) ACP self-efficacy. In a cluster-randomized controlled trial, the intervention was not superior to control in increasing these outcomes. A parallel process evaluation aimed to enhance understanding of how the intervention was implemented, and which factors might have influenced trial results. Methods We conducted a mixed-methods process evaluation following the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources include recruitment and implementation monitoring, questionnaires for patients and GPs, and semi-structured (focus group) interviews with patients and GPs. Questionnaire data were analyzed descriptively. Qualitative data were first analyzed inductively; themes were then assigned deductively to RE-AIM dimensions. Results Thirty-five GPs and 95 patients were recruited to the trial; GP reach was low. Sixteen GPs and 46 patients provided questionnaire data at 3 months post-baseline; qualitative data were transcribed for 14 GPs and 11 patients. Adoption of intervention components was moderate to good, with the exception of the documentation template for GPs. Interviews revealed varying patient attitudes towards ACP, but patients nonetheless emphasized that conversations made them feel reassured. GPs especially valued a positive framing of ACP. When adopted, the intervention was well-implemented and participant satisfaction was high. However, intention for maintenance was moderate, with GPs raising questions of how to sustainably implement ACP conversations in the future. Conclusions Implementing the complex ACP-GP intervention in general practice is feasible, and can be successful. However, the implementation process is challenging and the sustainability is suboptimal. Our findings will guide future research and recommendations for facilitating and implementing ACP in general practice. Trial registration ISRCTN12995230; prospectively registered on 19/06/2020.

Aim: The purpose of this study was to investigate how a randomised controlled trial (RCT) of an adapted diabetes nutrition education programme (NEP) was received by adults with sub-optimally controlled (HbA1c of ≥ 8%) type 2 diabetes in a tertiary setting. This could aid in understanding the small effect of NEP on HbA1c and other outcomes and the high attrition rate.Methods: This qualitative study was done alongside the year-long RCT. In the RCT, intervention participants received four NEP components, and both intervention and control group participants received education materials (fridge/wall poster). Five focus-group discussions were held with the intervention group participants at two time periods: after they completed the NEP curriculum (7th month) (n = 26; 67% of randomised participants [RP]( and at the end of the study (12 months) [n = 24; 61.5% RP). Nineteen (50% RP) control group participants were individually interviewed at the end of the study. Data were analysed using a thematic framework.Results: All participants (control and intervention) reported high satisfaction with the NEP. Participants emphasised the value of the fridge/wall poster for themselves and their families. Participants (control and intervention) reported various benefits of the NEP: improved diabetes knowledge, skills in dietary self-care, family support for self-care, better health and motivation for appropriate self-care. Some participants also reported positive changes to their diet and physical activity behaviours. The perceived benefits were the main reason for completing the study.Conclusions: Irrespective of the arm of participation, the NEP was well received, and perceived benefits inspired participation. The limited NEP impact and the sub-optimal programme participation do not appear to be related to participants’ perceptions of the adapted NEP.

Abstract Background Evaluation publications typically summarize the results of studies to demonstrate the effectiveness of an intervention, but little is shared concerning any changes implemented during the study. We present a process evaluation protocol of a home-based gait, balance, and resistance exercise intervention to ameliorate persistent taxane-induced neuropathy study according to 7 key elements of process evaluation. Methods The process evaluation is conducted parallel to the longitudinal, randomized control clinical trial examining the effects of the home-based gait, balance, and resistance exercise program for women with persistent peripheral neuropathy following treatment with taxanes for breast cancer (IRB approval: Pro00040035). The flowcharts clarify how the intervention should be implemented in comparable settings, fidelity procedures help to ensure the participants are comfortable and identify their individual needs, and the process evaluation allows for the individual attention tailoring and focus of the research to avoid protocol deviation. Conclusions The publication of the evaluation protocol plan adds transparency to the findings of clinical trials and favors process replication in future studies. The process evaluation enables the team to systematically register information and procedures applied during recruitment and factors that impact the implementation of the intervention, thereby allowing proactive approaches to prevent deviations from the protocol. When tracking an intervention continuously, positive or negative intervention effects are revealed early on in the study, giving valuable insight into inconsistent results. Furthermore, a process evaluation adds a participant-centered element to the research protocols, which allows a patient-centered approach to be applied to data collection. Trial registration ClinicalTrials.gov NCT04621721, November 9, 2020, registered prospectively. Protocol version: April 27, 2020, v2.

Purpose: The purpose of this study was to evaluate the process and overall feasibility of a doula grant program for expectant families from economically vulnerable backgrounds. Design: A mixed-methods process evaluation framework was utilized to examine program feasibility and focused on constructs related to fidelity, dose delivered/dose received, reach, program satisfaction, and limited efficacy testing. Measures: Evaluation constructs were measured using a program tracking document. Program satisfaction and efficacy were examined through a mixed methodology approach utilizing doula surveys and birthing parent interviews. Analysis: Related to survey data, analysis focused on presenting descriptive counts and percentages related to the number of doulas that participated and clients served. Continuous variables were calculated as means and standard deviations and categorical data as counts and percentages. Qualitative data analyses were conducted using a structured deductive thematic approach. Results: The grant program was successfully implemented over an 18-month period, and the program had a high rate of fidelity to the grant processes developed by a Midwestern-based nonprofit organization. The program was satisfactory to doulas and parents, and the largest barrier was communication. A high incidence of prenatal anxiety among the birthing parents was reported. Thematic findings from the birthing parent interviews included the following: the grant application process was effective and easy, birth doulas were greatly valued, and a financial burden was lifted. Conclusion: This grant process can be replicated by other organizations seeking to fill a gap between doula services and the economically vulnerable.

Abstract It has been difficult to demonstrate that interprofessional education (IPE) and interprofessional collaboration (IPC) have positive effects on patient care quality, cost effectiveness of patient care, and healthcare provider satisfaction. Here we propose a detailed explanation for this difficulty based on an adjusted theory about cause and effect in the field of IPE and IPC by asking: 1) What are the critical weaknesses of the causal models predominantly used which link IPE with IPC, and IPE and IPC with final outcomes? 2) What would a more precise causal model look like? 3) Can the proposed novel model help us better understand the challenges of IPE and IPC outcome evaluations? In the format of a critical theoretical discussion, based on a critical appraisal of the literature, we first reason that a monocausal, IPE-biased view on IPC and IPC outcomes does not form a sufficient foundation for proper IPE and IPC outcome evaluations; rather, interprofessional organization (IPO) has to be considered an additional necessary cause for IPC; and factors outside of IPC additional causes for final outcomes. Second, we present an adjusted model representing the “multi-stage multi-causality” of patient, healthcare provider, and system outcomes. Third, we demonstrate the model’s explanatory power by employing it to deduce why misuse of the modified Kirkpatrick classification as a causal model in IPE and IPC outcome evaluations might have led to inconclusive results in the past. We conclude by applying the derived theoretical clarification to formulate recommendations for enhancing future evaluations of IPE, IPO, and IPC. Our main recommendations: 1) Focus should be placed on a comprehensive evaluation of factual IPC as the fundamental metric and 2) A step-by-step approach should be used that separates the outcome evaluation of IPE from that of IPC in the overarching quest for proving the benefits of IPE, IPO and IPC for patients, healthcare providers, and health systems. With this critical discussion we hope to enable more effective evaluations of IPE, IPO and IPC in the future.