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Parent caregivers of children requiring life-saving medical technology (e.g., mechanical ventilation) report higher levels of stress and poorer health than other caregivers, often neglecting health-promoting behaviors for themselves. This article describes an iterative implementation science strategy used to improve intervention delivery for a randomized controlled trial testing a telehealth, cognitive-behavioral resourcefulness intervention with this population during the COVID-19 pandemic. This process consisted of reflective team meetings and content analysis. Initial adjustments were made after content analysis of pilot study materials before intervention delivery including an intervention script, checklist, online daily log, Health Insurance Portability and Accountability Act (HIPAA)-compliant texting option, training material access, and fidelity checks. In vivo adjustments were implemented in four areas: recruitment/engagement, participation and use of resources, in-person delivery, and virtual delivery. Our efforts to streamline intervention delivery were enhanced by incorporating an iterative implementation science strategy including analysis and adjustment of intervention delivery procedures to decrease participant burden and promote intervention adherence. Reflective team meetings and a collaborative, problem-solving approach to resolve the various barriers and challenges with the randomized controlled trial were integral components of intervention delivery. This study informs future intervention research by providing details of barriers faced, pragmatic adjustments made to intervention implementation, and lessons learned (NCT0410524; www.clinicaltrials.gov). [ABSTRACT FROM AUTHOR]

Background: Primary dental care settings are strategically important locations where randomised controlled trials (RCTs) of behaviour change interventions (BCIs) can be tested to tackle oral diseases. Findings have so far produced equivocal results. Improving treatment fidelity is posed as a mechanism to improve scientific rigour, consistency and implementation of BCIs. The National Institutes of Health Behaviour Change Consortium (NIH BCC) developed a tool to assess and evaluate treatment fidelity in health behaviour change interventions, which has yet to be applied to the primary dental care BCI literature. Method: We conducted a scoping review of RCTs delivered in primary dental care by dental team members (in real-world settings) between 1980 and 2023. Eligible studies were coded using the NIH BCC checklist to determine the presence of reported fidelity strategies across domains: design, training, delivery, receipt and enactment. Results: We included 34 eligible articles, reporting 21 RCTs. Fidelity reporting variations were found both between and within NIH BCC domains: strategy reporting ranged from 9.5 to 85.7% in design, 9.5 to 57.1% in training, 0 to 66.7% in delivery, 14.3 to 36.8% in receipt and 13.3 to 33.3% in enactment. The most reported domain was design (M = 0.45), and the least reported domain was delivery (M = 0.21). Only one study reported over 50% of the recommended strategies in every domain. Conclusions: This review revealed inconsistencies in fidelity reporting with no evidence that fidelity guidelines or frameworks were being used within primary dental care trials. This has highlighted issues with interpretability, reliability and reproducibility of research findings. Recommendations are proposed to assist primary dental care trialists with embedding fidelity strategies into future research. [ABSTRACT FROM AUTHOR]

Abstract Background Placement interventions, characterised by greater availability and more prominent positioning of healthy food products in supermarkets and other food stores, are associated with healthier patterns of purchasing and diet. The WRAPPED intervention study is a natural experiment that aims to evaluate a supermarket placement intervention to improve fruit and vegetable sales, household purchasing and the dietary quality of women and their children. Process evaluation, alongside the evaluation of outcomes, is essential to understand how interventions are implemented, under what circumstances they are effective, and their mechanisms of impact. This study aimed to assess the implementation of the WRAPPED placement intervention. Methods The study adopted a convergent mixed-methods design. Quantitative data extracted from study store planograms (visual representation of stores and product placement) before and after intervention implementation were used to assess the positioning of fresh fruit and vegetables in the first aisle from the front entrance (intervention dose). The availability of fresh fruit and vegetables in each study store was examined from stock-keeping unit (SKU) figures before and after intervention implementation. An intervention implementation survey (IIS) completed with store managers and senior supervisors before and 1- and 6-months post-intervention implementation enabled examination of the context across study stores. Semi-structured interviews with store managers and senior supervisors provided qualitative data about store staff experiences and perceptions of the intervention between 6-months post-intervention implementation. Results The placement intervention was implemented with close adherence to the study protocol. There were marked differences, post-intervention implementation, in the positioning of fresh fruit and vegetables in intervention stores compared with control stores: median distance in intervention stores was 8.0 m (IQR 5.0 to 10.0) compared with 23.8 m (IQR 21.0 to 30.0) in control stores (P

School-based health promotion (HP) emerged from the settings-based approach. Children from disadvantaged neighborhoods benefit from HP in their school. Teachers deliver HP modules but need additional resources. This case study aimed to form a transdisciplinary partnership in a socially disadvantaged area to co-develop and embed HP modules into existing curricula. A 3-stage framework was used in this study. Stage 1 cultivated partnerships, reviewed evidence and existing data. Stage 2 generated ideas and co-developed HP modules. Stage 3 trialed the modules within primary school classrooms. Stage 1 resulted in a partnership between city authorities, a primary school and a comprehensive cancer center all located in the same community in France. The reviewed data and evidence provided 18 examples of school-based HP programs and showed that the school is in a highly disadvantaged neighborhood with a large immigrant population. Stage 2 developed 3 HP modules: "Taste and Science Week," "Nutrition Weeks," and "Breakfast Week," each embedded as add-ins into existing math and science lessons and workshops. Finally, stage 3 trialed the modules in 10 first to fifth grade classrooms impacting 214 total students. Transdisciplinary partnerships help co-create and support evidence-driven HP programs. This collaborative approach enabled primary school teachers to effectively embed the HP modules into pre-existing math and science curricula. Families and volunteers are an integral part of successful HP programs however, limited participation was a challenge. Further research is needed to evaluate indicators such as student academic success and health behavior change. [ABSTRACT FROM AUTHOR]

Background: Placement interventions, characterised by greater availability and more prominent positioning of healthy food products in supermarkets and other food stores, are associated with healthier patterns of purchasing and diet. The WRAPPED intervention study is a natural experiment that aims to evaluate a supermarket placement intervention to improve fruit and vegetable sales, household purchasing and the dietary quality of women and their children. Process evaluation, alongside the evaluation of outcomes, is essential to understand how interventions are implemented, under what circumstances they are effective, and their mechanisms of impact. This study aimed to assess the implementation of the WRAPPED placement intervention. Methods: The study adopted a convergent mixed-methods design. Quantitative data extracted from study store planograms (visual representation of stores and product placement) before and after intervention implementation were used to assess the positioning of fresh fruit and vegetables in the first aisle from the front entrance (intervention dose). The availability of fresh fruit and vegetables in each study store was examined from stock-keeping unit (SKU) figures before and after intervention implementation. An intervention implementation survey (IIS) completed with store managers and senior supervisors before and 1- and 6-months post-intervention implementation enabled examination of the context across study stores. Semi-structured interviews with store managers and senior supervisors provided qualitative data about store staff experiences and perceptions of the intervention between 6-months post-intervention implementation. Results: The placement intervention was implemented with close adherence to the study protocol. There were marked differences, post-intervention implementation, in the positioning of fresh fruit and vegetables in intervention stores compared with control stores: median distance in intervention stores was 8.0 m (IQR 5.0 to 10.0) compared with 23.8 m (IQR 21.0 to 30.0) in control stores (P < 0.0001). The availability of varieties of fresh fruit and vegetables increased in intervention stores post-intervention compared with control stores: median (IQR) among intervention stores was 72 (51, 84) compared with 56.5 (50, 62) in control stores (P = 0.03). The mean change from baseline to post-implementation in number of different fruit and vegetables available in intervention stores was 15.3 (SD 16.7) (P = 0.01). IIS and interview data demonstrated little difference between intervention and store contexts over time. Reinforcing factors for intervention implementation included: head-office leadership, store staff views and attitudes and increased awareness of the importance of offering healthy food in prominent locations within stores. Conclusion: This study demonstrated that placement interventions which promote fresh fruit and vegetables to customers in discount supermarkets can be implemented effectively. These findings are encouraging for the implementation of national food policies which modify retail environments to improve population purchasing and dietary patterns. Trial registration: NCT03573973; Pre-results. [ABSTRACT FROM AUTHOR]

Purpose: For the first time in France, a randomised controlled trial was conducted to evaluate the impact of a nurse facilitator on family psychological symptoms. We sought to explore the implementation of the intervention, how it was experienced by clinicians, as well as the barriers and facilitators to implementing the change. Methods: We conducted qualitative semi-structured interviews with intensive care unit (ICU) clinicians and facilitators involved in the trial. Interview questions focused on participants' perceptions of the intervention and its outcomes, including the effect of the intervention on patients, families and the health care team, and barriers and facilitators to its implementation. Interviews were conducted by two social science researchers, audio recorded, transcribed, and analyzed using thematic content analysis. Results: Twenty-three clinicians were interviewed from the five participating ICUs. Three themes emerged, capturing clinicians' perspectives on implementing the intervention: (1) improved communication and enhanced care for families and the ICU team, albeit with some associated risks; (2) active listening and support, both for families and ICU clinicians but with certain limitations; (3) barriers to implementation including lack of organizational readiness, exclusion of under-represented groups, and facilitator challenges including role ambiguity and the need for role support. Conclusion: Participants believed the facilitator intervention potentially improved families' experience. However, they also highlighted emotional difficulties and tensions with some members of the participating teams, due to competing territories and ambiguous role definitions. Facilitators' failure to affect decision-making suggests their role in enhancing goal-concordant care was inadequate within the setting. [ABSTRACT FROM AUTHOR]

Abstract Background Although there are many proven effective physical activity (PA) interventions for older adults, implementation in a real world setting is often limited. This study describes the systematic development of a multifaceted implementation intervention targeting the implementation of an evidence-based computer-tailored PA intervention and evaluates its use and feasibility. Methods The implementation intervention was developed following the Intervention Mapping (IM) protocol, supplemented with insights from implementation science literature. The implementation intervention targets the municipal healthcare policy advisors, as an important implementation stakeholder in Dutch healthcare system. The feasibility of the implementation intervention was studied among these stakeholders using a pretest–posttest design within 8 municipal healthcare settings. Quantitative questionnaires were used to assess task performance (i.e. achievement of performance objectives), and utilization of implementation strategies (as part of the intervention). Furthermore, changes in implementation determinants were studied by gathering quantitative data before, during and after applying the implementation intervention within a one-year period. Additionally, semi-structured interviews with stakeholders assessed their considerations regarding the feasibility of the implementation intervention. Results A multi-faceted implementation intervention was developed in which implementation strategies (e.g. funding, educational materials, meetings, building a coalition) were selected to target the most relevant identified implementation determinants. Most implementation strategies were used as intended. Execution of performance objectives for adoption and implementation was relatively high (75–100%). Maintenance objectives were executed to a lesser degree (13–63%). No positive changes in implementation determinants were found. None of the stakeholders decided to continue implementation of the PA intervention further, mainly due to the unforeseen amount of labour and the disappointing reach of end-users. Conclusion The current study highlights the importance of a thorough feasibility study in addition to the use of IM. Although feasibility results may have demonstrated that stakeholders broadly accepted the implementation intervention, implementation determinants did not change favorably, and stakeholders had no plans to continue the PA intervention. Yet, choices made during the development of the implementation intervention (i.e. the operationalization of Implementation Mapping) might not have been optimal. The current study describes important lessons learned when developing an implementation intervention, and provides recommendations for developers of future implementation interventions.

Abstract Background A shift away from diets high in animal-based foods towards diets high in plant-based foods is desirable considering human health, environmental sustainability, and animal welfare. As the food environment plays a crucial role in shaping consumption patterns, understanding of how changes in the food environment can facilitate plant-based consumption is crucial for the so-called protein transition. The current study aims to garner insight into barriers and facilitators for food outlet managers to take action to stimulate plant-based consumption within a local food environment. Methods Using a maximum-variation sample approach, we examined possible barriers and facilitators to promote plant-based consumption across different types of food outlets located within a geographically shared food environment (a city in the Netherlands). We conducted in-depth semi-structured interviews among food outlet managers and applied multi-stage thematic analysis to the interview transcripts. Results Most managers underscored the urgency of shifting towards more plant-based diets, and perceived a growing demand for plant-based products. However, three barriers hindered most of them from taking decisive action: Managers’ perception of low consumer demand for plant-based food options; fear of consumer resistance when stimulating plant-based food options; and limited behavioral agency to offer attractive plant-based food options. The few managers who made changes, or intend to make changes, are individuals with high intrinsic motivation, knowledge and skills. Conclusions The present work suggests the key for change towards a food environment stimulating plant-based consumption lies in addressing three (perceived) barriers shared among diverse outlets. These are partly different from barriers for stimulating healthy consumption in general. Furthermore, current changes appear to be driven incidentally by individuals who are motivated and able to stimulate more plant-based purchases among a small targeted group of consumers.

Background: Although there are many proven effective physical activity (PA) interventions for older adults, implementation in a real world setting is often limited. This study describes the systematic development of a multifaceted implementation intervention targeting the implementation of an evidence-based computer-tailored PA intervention and evaluates its use and feasibility. Methods: The implementation intervention was developed following the Intervention Mapping (IM) protocol, supplemented with insights from implementation science literature. The implementation intervention targets the municipal healthcare policy advisors, as an important implementation stakeholder in Dutch healthcare system. The feasibility of the implementation intervention was studied among these stakeholders using a pretest–posttest design within 8 municipal healthcare settings. Quantitative questionnaires were used to assess task performance (i.e. achievement of performance objectives), and utilization of implementation strategies (as part of the intervention). Furthermore, changes in implementation determinants were studied by gathering quantitative data before, during and after applying the implementation intervention within a one-year period. Additionally, semi-structured interviews with stakeholders assessed their considerations regarding the feasibility of the implementation intervention. Results: A multi-faceted implementation intervention was developed in which implementation strategies (e.g. funding, educational materials, meetings, building a coalition) were selected to target the most relevant identified implementation determinants. Most implementation strategies were used as intended. Execution of performance objectives for adoption and implementation was relatively high (75–100%). Maintenance objectives were executed to a lesser degree (13–63%). No positive changes in implementation determinants were found. None of the stakeholders decided to continue implementation of the PA intervention further, mainly due to the unforeseen amount of labour and the disappointing reach of end-users. Conclusion: The current study highlights the importance of a thorough feasibility study in addition to the use of IM. Although feasibility results may have demonstrated that stakeholders broadly accepted the implementation intervention, implementation determinants did not change favorably, and stakeholders had no plans to continue the PA intervention. Yet, choices made during the development of the implementation intervention (i.e. the operationalization of Implementation Mapping) might not have been optimal. The current study describes important lessons learned when developing an implementation intervention, and provides recommendations for developers of future implementation interventions. [ABSTRACT FROM AUTHOR]

Partnering with promotoras to implement a healthy lifestyle intervention has proven efficacious in reaching community members whom they serve. However, there are no clearly defined guidelines for implementing promotora training, especially when it involves developing mindfulness skills in promotoras unfamiliar with this concept. This is a report about the facilitators and barriers to training promotoras to implement a mindfulness-enhanced healthy eating and physical activity intervention, ADAPT+ , using the Train-the-Trainer model. Following this model, we laid the foundations for sustained implementation of ADAPT+ even after the training process. Future studies may examine how these guidelines help map promotora training in other mindfulness-related interventions. [ABSTRACT FROM AUTHOR]

School-based health promotion (HP) emerged from the settings-based approach. Children from disadvantaged neighborhoods benefit from HP in their school. Teachers deliver HP modules but need additional resources. This case study aimed to form a transdisciplinary partnership in a socially disadvantaged area to co-develop and embed HP modules into existing curricula. A 3-stage framework was used in this study. Stage 1 cultivated partnerships, reviewed evidence and existing data. Stage 2 generated ideas and co-developed HP modules. Stage 3 trialed the modules within primary school classrooms. Stage 1 resulted in a partnership between city authorities, a primary school and a comprehensive cancer center all located in the same community in France. The reviewed data and evidence provided 18 examples of school-based HP programs and showed that the school is in a highly disadvantaged neighborhood with a large immigrant population. Stage 2 developed 3 HP modules: “Taste and Science Week,” “Nutrition Weeks,” and “Breakfast Week,” each embedded as add-ins into existing math and science lessons and workshops. Finally, stage 3 trialed the modules in 10 first to fifth grade classrooms impacting 214 total students. Transdisciplinary partnerships help co-create and support evidence-driven HP programs. This collaborative approach enabled primary school teachers to effectively embed the HP modules into pre-existing math and science curricula. Families and volunteers are an integral part of successful HP programs however, limited participation was a challenge. Further research is needed to evaluate indicators such as student academic success and health behavior change.

Abstract Background Communities That HEAL (CTH) is a novel, data-driven community-engaged intervention designed to reduce opioid overdose deaths by increasing community engagement, adoption of an integrated set of evidence-based practices, and delivering a communications campaign across healthcare, behavioral-health, criminal-legal, and other community-based settings. The implementation of such a complex initiative requires up-front investments of time and other expenditures (i.e., start-up costs). Despite the importance of these start-up costs in investment decisions to stakeholders, they are typically excluded from cost-effectiveness analyses. The objective of this study is to report a detailed analysis of CTH start-up costs pre-intervention implementation and to describe the relevance of these data for stakeholders to determine implementation feasibility. Methods This study is guided by the community perspective, reflecting the investments that a real-world community would need to incur to implement the CTH intervention. We adopted an activity-based costing approach, in which resources related to hiring, training, purchasing, and community dashboard creation were identified through macro- and micro-costing techniques from 34 communities with high rates of fatal opioid overdoses, across four states—Kentucky, Massachusetts, New York, and Ohio. Resources were identified and assigned a unit cost using administrative and semi-structured-interview data. All cost estimates were reported in 2019 dollars. Results State-level average and median start-up cost (representing 8–10 communities per state) were $268,657 and $175,683, respectively. Hiring and training represented 40%, equipment and infrastructure costs represented 24%, and dashboard creation represented 36% of the total average start-up cost. Comparatively, hiring and training represented 49%, purchasing costs represented 18%, and dashboard creation represented 34% of the total median start-up cost. Conclusion We identified three distinct CTH hiring models that affected start-up costs: hospital-academic (Massachusetts), university-academic (Kentucky and Ohio), and community-leveraged (New York). Hiring, training, and purchasing start-up costs were lowest in New York due to existing local infrastructure. Community-based implementation similar to the New York model may have lower start-up costs due to leveraging of existing infrastructure, relationships, and support from local health departments.

Background: Communities That HEAL (CTH) is a novel, data-driven community-engaged intervention designed to reduce opioid overdose deaths by increasing community engagement, adoption of an integrated set of evidence-based practices, and delivering a communications campaign across healthcare, behavioral-health, criminal-legal, and other community-based settings. The implementation of such a complex initiative requires up-front investments of time and other expenditures (i.e., start-up costs). Despite the importance of these start-up costs in investment decisions to stakeholders, they are typically excluded from cost-effectiveness analyses. The objective of this study is to report a detailed analysis of CTH start-up costs pre-intervention implementation and to describe the relevance of these data for stakeholders to determine implementation feasibility. Methods: This study is guided by the community perspective, reflecting the investments that a real-world community would need to incur to implement the CTH intervention. We adopted an activity-based costing approach, in which resources related to hiring, training, purchasing, and community dashboard creation were identified through macro- and micro-costing techniques from 34 communities with high rates of fatal opioid overdoses, across four states—Kentucky, Massachusetts, New York, and Ohio. Resources were identified and assigned a unit cost using administrative and semi-structured-interview data. All cost estimates were reported in 2019 dollars. Results: State-level average and median start-up cost (representing 8–10 communities per state) were $268,657 and $175,683, respectively. Hiring and training represented 40%, equipment and infrastructure costs represented 24%, and dashboard creation represented 36% of the total average start-up cost. Comparatively, hiring and training represented 49%, purchasing costs represented 18%, and dashboard creation represented 34% of the total median start-up cost. Conclusion: We identified three distinct CTH hiring models that affected start-up costs: hospital-academic (Massachusetts), university-academic (Kentucky and Ohio), and community-leveraged (New York). Hiring, training, and purchasing start-up costs were lowest in New York due to existing local infrastructure. Community-based implementation similar to the New York model may have lower start-up costs due to leveraging of existing infrastructure, relationships, and support from local health departments. [ABSTRACT FROM AUTHOR]

Bright light therapy (BLT) is efficacious for seasonal and non-seasonal depression. However, the current state of BLT use in practice is unknown, impeding efforts to identify and address utilization gaps. This study's objective was to investigate BLT delivery in a nationwide U.S. healthcare system. This was a retrospective observational study of electronic medical records from all veterans who received outpatient mood disorder-related care in the Veterans Health Administration (VHA) from October 2008 through September 2020. BLT delivery was measured through the placement of light box consults. Of the 3,442,826 veterans who received outpatient mood disorder care, only 57,908 (1.68 %) received a light box consult. Consults increased by 548.44 % (99.9 % credible interval: 467.36 %, 638.74 %) over the timeframe and displayed a robust yearly cycle that peaked on either December 21st or December 22nd. Past mental health treatment for a mood disorder was associated with a higher probability of a consult (relative risk = 4.79, 99.9 % CI: 4.21, 5.60). There was low representation related to veteran age, gender, race, and ethnicity. No information on patients who declined light boxes or actual light box use following consult placement. Outpatient BLT delivery for mood disorders in the VHA remains low, despite significant growth over the past decade. It also displays a strong seasonal rhythm that peaks on the winter solstice, suggesting a limited focus on seasonal depression and a suboptimal reactive approach to changing sunlight. Overall, there exists ample opportunity for novel implementation efforts aimed at increasing utilization of BLT. • Despite growth over the past 12 years, bright light therapy sees infrequent use. • Light box delivery peaks on the winter solstice and is minimal in summer. • There is low representation of light box delivery across veteran groups. • There is opportunity to expand bright light delivery and enhance depression care. [ABSTRACT FROM AUTHOR]

Background: Strength of evidence is key to advancing children's mental health care but may be inadequate for driving practice change. The Designing for Accelerated Translation (DART) framework proposes a multifaceted approach: pace of implementation as a function of evidence of effectiveness, demand for the intervention, sum of risks, and costs. To inform empirical applications of DART, we solicited caregiver preferences on key elements. Method: In March–April 2022, we fielded a population-representative online survey in Illinois households (caregivers N = 1,326) with ≥1 child <8 years old. Six hypothetical scenarios based on the DART framework were used to elucidate caregivers' preferences on a 0–10 scale (0 = never; 10 = as soon as possible) for pace of implementation of a family-based program to address mental health concerns. Results: Caregivers' pace preference scores varied significantly for each scenario. The highest mean score (7.28, 95% confidence interval [95% CI: 7.06, 7.50]) was for a scenario in which the child's provider thinks the program would be helpful (effectiveness) and the caregiver believes the program is needed (demand). In contrast, the lowest mean score (5.13, 95% CI [4.91, 5.36]) was for a scenario in which online information implies the program would be helpful (effectiveness) and the parent is concerned about the program's financial costs (cost). Caregivers' pace preference scores did not vary consistently by sociodemographic factors. Conclusion: In this empirical exploration of the DART framework, factors such as demand, cost, and risk, in combination with evidence of effectiveness, may influence caregivers' preferred pace of implementation for children's mental health interventions. Public Significance Statement: Evidence-based practices for children and families are typically slow to move from discovery and testing to real-world clinical practice. Understanding potential determinants of the pace of translation of these practices from various perspectives (e.g., parents) is important for widespread and rapid implementation. [ABSTRACT FROM AUTHOR]

Abstract Background While benefiting from strong cultural ties to family, land and culture Native Americans residing on reservations experience psychological distress at rates 2.5 times that of the general population. Treatment utilization for psychological health in reservation-based communities is low with access to culturally appropriate care lacking. Evidence suggests that for mental health treatment, Native Americans prefer culturally informed care that respects Native perspectives on health and well-being. Methods To decrease stress and promote well-being in tribal Head Start teachers we adapted and implemented a culturally focused intervention within a community-based participatory research framework using mixed methods. Feasibility and acceptability of the adapted 5-session curriculum was tested in a single arm intervention study with a sample of 18 teachers on the Fort Peck Reservation. Participants completed surveys at baseline and upon completion of the intervention. Within session observations and two post-intervention focus groups (n = 8, n = 10) were conducted to elaborate and explain the quantitative results eliciting participant experience of intervention effectiveness and feasibility, acceptably and appropriateness. Implementation outcomes were assessed quantitatively using the Acceptability of Intervention, Intervention Appropriateness, and Feasibility of Intervention measures. Results Quantitively, attendance rate overall was 93% with no dropouts. Pretest/posttest surveys were analyzed using t-tests and Hedges g to measure effect size. Contrary to our hypothesis, self-perceived stress showed a small positive effect size, indicating that participants were more stressed post intervention. However, depression decreased, with tribal identity and resilience showing positive effect sizes. Content analysis for the qualitative data collected within session observations and post intervention focus groups revealed how lifetime traumas were affecting participants, providing some explanation for the increase in stress. Teachers reported that the sessions helped their psychological health and well-being, supporting feasibility of future interventions. Acceptability scored highest with a mean (SD) of 4.25 (.84) out of 5, appropriateness 4.18 (.86) and feasibility 4.06 (.96) supporting intervention to be acceptable, appropriate, and feasible. Conclusion Utilizing a culturally based intervention to buffer stress and support the well-being of reservation-based teachers showed promise in helping them recognize their cultural strengths, stress, and need for ongoing support. Implementation outcomes show that intervention scale-out is feasible.

Abstract Background Caesarean section (CS) rates are increasing globally, posing risks to women and babies. To reduce CS, educational interventions targeting pregnant women have been implemented globally, however, their effectiveness is varied. To optimise benefits of these interventions, it is important to understand which intervention components influence success. In this study, we aimed to identify essential intervention components that lead to successful implementation of interventions focusing on pregnant women to optimise CS use. Methods We re-analysed existing systematic reviews that were used to develop and update WHO guidelines on non-clinical interventions to optimise CS. To identify if certain combinations of intervention components (e.g., how the intervention was delivered, and contextual characteristics) are associated with successful implementation, we conducted a Qualitative Comparative Analysis (QCA). We defined successful interventions as interventions that were able to reduce CS rates. We included 36 papers, comprising 17 CS intervention studies and an additional 19 sibling studies (e.g., secondary analyses, process evaluations) reporting on these interventions to identify intervention components. We conducted QCA in six stages: 1) Identifying conditions and calibrating the data; 2) Constructing truth tables, 3) Checking quality of truth tables; 4) Identifying parsimonious configurations through Boolean minimization; 5) Checking quality of the solution; 6) Interpretation of solutions. We used existing published qualitative evidence synthesis to develop potential theories driving intervention success. Results We found successful interventions were those that leveraged social or peer support through group-based intervention delivery, provided communication materials to women, encouraged emotional support by partner or family participation, and gave women opportunities to interact with health providers. Unsuccessful interventions were characterised by the absence of at least two of these components. Conclusion We identified four key essential intervention components which can lead to successful interventions targeting women to reduce CS. These four components are 1) group-based delivery, 2) provision of IEC materials, 3) partner or family member involvement, and 4) opportunity for women to interact with health providers. Maternal health services and hospitals aiming to better prepare women for vaginal birth and reduce CS can consider including the identified components to optimise health and well-being benefits for the woman and baby.

Latina and Vietnamese women are disproportionately burdened by human papillomavirus (HPV)-associated cervical cancer and underutilize the HPV vaccine, which is an effective cancer prevention measure. To inform the adaptation of a National Cancer Institute's evidence-based cancer control program, HPV Vaccine Decision Narratives, and because of the rapidly changing information concerning consumption patterns of young adults, we elicited preferences and characteristics associated with women's interest in various health information sources, specifically for HPV vaccination. We conducted 50 interviews with young Latina and Vietnamese women at two Planned Parenthood health centers in Southern California. Interview questions were guided by the Channel Complementarity Theory and focused on understanding the multiple communication channels women turn to for health, and the characteristics that motivate their use. Our results showed that Latina and Vietnamese women turn to many sources, from online and social media to school health classes, mothers, and doctors. Specific characteristics that motivate women's online use of health information included immediacy and access, convenience and credibility. When receiving HPV vaccine information, privacy, avoiding information overload, interpersonal engagement, and receiving health information from trusted sources was important. Our study advances the prevention literature by elevating the role of platform delivery considerations and emphasizing preferences to effectively reach Latina and Vietnamese women, who are disproportionately burdened by HPV cancers and are less aware of HPV vaccine prevention. These results can be used to further inform the dissemination of this cancer control program. Adaptation of the program should include changes to its delivery, such that trusted sources are used, and dissemination is coordinated to send a consistent message across multiple communication methods.

Abstract Background Low birthweight and preterm birth rates are higher in the United States than in other developed countries and exhibit pronounced racial inequities. Home visiting is a strategy to promote equity in birth outcomes. Research points to precision home visiting as the path to equity. The purpose of this study is to describe local programs’ risk reduction priorities, intended behavioral pathways, and expectations of home visitors; compare these local program features with those of their national model; and assess the strength of implementation systems to support staff in meeting job expectations. Methods We surveyed local programs implementing one of four evidence-based home visiting models that aim to promote good birth outcomes: Family Spirit, Healthy Families America, Nurse-Family Partnership, and Parents as Teachers. Results Representatives from 169 local programs completed the survey. Overall, 59% endorsed all their model’s high priority risks, 16% endorsed all its required behavioral pathways, and 11% endorsed all its required techniques. Local programs went beyond their national model’s explicit intentions. Overall, 91% of local programs prioritized risks beyond those of their model, 85% endorsed behavioral pathways beyond those of their model, 95% endorsed visitors’ use of techniques not explicitly endorsed by their model but compatible with it, and 19% endorsed use of techniques judged incompatible by their model. Implementation system strength was positively associated with local program and model expectations. Conclusions Precision home visiting to achieve health equity requires shared learning of what works best for whom. This observational study showed the Precision Paradigm’s usefulness for cross-model research to advance precision.

Abstract Introduction: Community health workers (CHWs) stand as critical frontline agents within the Brazilian healthcare system. In this qualitative study, we examined the impact of a community-based behavioral change intervention spearheaded by CHWs. Methods: The intervention focused on promoting healthy behaviors – physical activity, nutrition, and emotional well-being – among individuals aged 50 and older living in a rural community in Brazil. The intervention was designed, implemented, and evaluated in close collaboration with CHWs and local administrators. The implementation of the intervention unfolded in two waves, each lasting 12 months. Interviews with CHWs, health administrators, and intervention participants conducted at post-intervention and 6-year follow-up centered on CHWs as delivery agents and examined the implementation of the intervention in primary care contexts around adoption, implementation, and long-term maintenance. Results: Inductive analysis revealed four themes that highlight CHWs’ motivation to take active roles in health promotion and overcoming challenges such as unfamiliarity with new roles or limited training. In addition, enhanced community bonds, job satisfaction, and trust in CHWs gained through the intervention, empowered CHWs to realize their potential and importance. Another important area relates to the CHWs’ ability to leverage their deep community ties and cultural insights to enhance the intervention’s significance. CHWs’ participation in the program also led to personal benefits and self-care practices, setting an example for the community they serve. Conclusions: This study underscores the positive impact of a community-based intervention led by CHWs. Such programs have the potential for nationwide dissemination, leveraging the CHWs’ widespread presence and deep community integration.

Background: Recognizing safety risks and promoting safe care is essential for care dependent people and should be an integral part of the overall preventive endeavors while providing care. The term 'safety culture' describes efforts regarding the acknowledgement and reduction of safety risks. Enhanced safety culture in health care organizations can be associated with a lower incidence of missed nursing care and adverse events. Objective: Identify strategies to enhance safety culture in long-term care settings and describe factors facilitating or inhibiting the process from the available evidence. Design: This systematic review is a narrative description of intervention studies. Methods: CINAHL and MEDLINE were searched in May 2020 using terms such as safety culture, safety climate, intervention development. Gray literature was searched between May and September 2020. An additional search in Cochrane Library was conducted in September 2022. Only intervention studies feasible to enhance the safety culture were included. Intervention study criteria were met when an organized, planned action to prevent or change a specific behavior took place and when this action was transparently and systematically evaluated. The screening, data extraction, and rating processes were conducted by two researchers independently. The ROBINS-I tool was utilized to assess the risk of bias of the studies. Results: Seven intervention studies were included, all evaluated with a critical risk of bias. Strategies found to enhance the safety culture in care settings include collegial exchange of experiences and learnings, integration of staff's perceptions, external facilitation, staff training, and a structured, multi-step procedure of the intervention process. Some studies were unable to show statistically significant enhancement in safety culture from the interventions implemented. Factors facilitating the implementation of interventions include good connections and trust between staff and managers, and the manager's active support of the project goals, as well as targeting achievable ideas considering time and resources. Time pressure, heavy workloads and high staff turnover may inhibit the process. Conclusions: All included studies had a high risk of bias, and possible effects must be considered accordingly. Overall, there was considerable heterogeneity in interventions aiming to enhance safety culture. Despite these aspects, promising approaches are training staff's knowledge and competencies regarding open communication and teamwork as part of a multifaceted program. Future research would benefit from participative, carefully developed, comprehensively evaluated interventions for enhancing safety culture, specifically within in-home care settings. Registration: The review was not pre-registered but described on the website of the Center for Quality in Care. Tweetable abstract: Participatory change management & staff training help ensure momentum & trust in endeavours to enhance safety culture in long-term care.

Background: While benefiting from strong cultural ties to family, land and culture Native Americans residing on reservations experience psychological distress at rates 2.5 times that of the general population. Treatment utilization for psychological health in reservation-based communities is low with access to culturally appropriate care lacking. Evidence suggests that for mental health treatment, Native Americans prefer culturally informed care that respects Native perspectives on health and well-being. Methods: To decrease stress and promote well-being in tribal Head Start teachers we adapted and implemented a culturally focused intervention within a community-based participatory research framework using mixed methods. Feasibility and acceptability of the adapted 5-session curriculum was tested in a single arm intervention study with a sample of 18 teachers on the Fort Peck Reservation. Participants completed surveys at baseline and upon completion of the intervention. Within session observations and two post-intervention focus groups (n = 8, n = 10) were conducted to elaborate and explain the quantitative results eliciting participant experience of intervention effectiveness and feasibility, acceptably and appropriateness. Implementation outcomes were assessed quantitatively using the Acceptability of Intervention, Intervention Appropriateness, and Feasibility of Intervention measures. Results: Quantitively, attendance rate overall was 93% with no dropouts. Pretest/posttest surveys were analyzed using t-tests and Hedges g to measure effect size. Contrary to our hypothesis, self-perceived stress showed a small positive effect size, indicating that participants were more stressed post intervention. However, depression decreased, with tribal identity and resilience showing positive effect sizes. Content analysis for the qualitative data collected within session observations and post intervention focus groups revealed how lifetime traumas were affecting participants, providing some explanation for the increase in stress. Teachers reported that the sessions helped their psychological health and well-being, supporting feasibility of future interventions. Acceptability scored highest with a mean (SD) of 4.25 (.84) out of 5, appropriateness 4.18 (.86) and feasibility 4.06 (.96) supporting intervention to be acceptable, appropriate, and feasible. Conclusion: Utilizing a culturally based intervention to buffer stress and support the well-being of reservation-based teachers showed promise in helping them recognize their cultural strengths, stress, and need for ongoing support. Implementation outcomes show that intervention scale-out is feasible. [ABSTRACT FROM AUTHOR]

Background: Caesarean section (CS) rates are increasing globally, posing risks to women and babies. To reduce CS, educational interventions targeting pregnant women have been implemented globally, however, their effectiveness is varied. To optimise benefits of these interventions, it is important to understand which intervention components influence success. In this study, we aimed to identify essential intervention components that lead to successful implementation of interventions focusing on pregnant women to optimise CS use. Methods: We re-analysed existing systematic reviews that were used to develop and update WHO guidelines on non-clinical interventions to optimise CS. To identify if certain combinations of intervention components (e.g., how the intervention was delivered, and contextual characteristics) are associated with successful implementation, we conducted a Qualitative Comparative Analysis (QCA). We defined successful interventions as interventions that were able to reduce CS rates. We included 36 papers, comprising 17 CS intervention studies and an additional 19 sibling studies (e.g., secondary analyses, process evaluations) reporting on these interventions to identify intervention components. We conducted QCA in six stages: 1) Identifying conditions and calibrating the data; 2) Constructing truth tables, 3) Checking quality of truth tables; 4) Identifying parsimonious configurations through Boolean minimization; 5) Checking quality of the solution; 6) Interpretation of solutions. We used existing published qualitative evidence synthesis to develop potential theories driving intervention success. Results: We found successful interventions were those that leveraged social or peer support through group-based intervention delivery, provided communication materials to women, encouraged emotional support by partner or family participation, and gave women opportunities to interact with health providers. Unsuccessful interventions were characterised by the absence of at least two of these components. Conclusion: We identified four key essential intervention components which can lead to successful interventions targeting women to reduce CS. These four components are 1) group-based delivery, 2) provision of IEC materials, 3) partner or family member involvement, and 4) opportunity for women to interact with health providers. Maternal health services and hospitals aiming to better prepare women for vaginal birth and reduce CS can consider including the identified components to optimise health and well-being benefits for the woman and baby. [ABSTRACT FROM AUTHOR]

BackgroundEngaging and retaining young men in community-based interventions is highly challenging. The purpose of this study was to investigate the individual factors that predict intervention engagement and adherence in a sample of at-risk South African men.MethodsBaseline data were collected as a part of a cluster randomised control trial (RCT) situated in Khayelitsha and Mfuleni, two peri-urban settlements situated on the outskirts of Cape Town, South Africa. Neighbourhoods were randomised to one of three intervention conditions. We performed univariate descriptive statistics to report neighbourhood and individual socio-demographic factors, and ran multivariate models, adjusting for entry of study, to determine if high adherence and consistency of engagement with the intervention were associated with socio-behavioural demographics and risk behaviours, such as hazardous substance use, gangsterism, and criminal activity.ResultsTotal of 729 men were on average 22.5 years old (SD 2.8), with a mean of 10 years of education. More than half of the sample were single (94%), lived with their parents (66%) and had an income below ~$30 (52%). The overall mean of adherence is 0.41 (SD 0.24) and mean of consistency of engagement is 0.61 (SD 0.30). Our data indicated that completing more years of education, living with parents, and having higher socioeconomic status were significantly associated with higher rates of engagement and adherence. Men with a history of gang membership demonstrated higher levels of adherence and consistent engagement with the intervention, compared with other men who were recruited to the intervention. Crucially, our data show that young men with a history of substance use, and young men who report symptoms of depression and high levels of perceived stress are equally likely as other young men to adhere to the intervention and attend intervention sessions consistently.ConclusionOur results may contribute to a better understanding of young men's patterns of engagement and adherence to public health interventions. The results may have important implications for policy and practice, as they may be useful in planning more effective interventions and could potentially be used to predict which young men can be reached through community-based interventions.Trial registrationClinicalTrials.gov registration, NCT02358226. Prospectively registered 24 November 2014.

Abstract Background The physical activity counseling for in-patients with major depression (PACINPAT) randomized controlled trial was launched to tackle physical inactivity for in-patients with major depressive disorder. Evidence shows that despite potential treatment effects, physical inactivity is prevalent in this population. To contribute to the assessment of how this in-person and remote, theory-based, individually tailored intervention was designed, received and effected behavior, the aim of this study was to evaluate its implementation. Methods This implementation evaluation was conducted within a multi-center randomized controlled trial according to the Process Evaluation Framework by the Medical Research Council including the analysis of reach, dose, fidelity and adaptation. Data were collected from the implementers and the participants randomized to the intervention group of the trial. Results The study sample comprised 95 physically inactive in-patients (mean age: 42 years, 53% women) with diagnosed major depressive disorder. The intervention reached the intended population (N = 95 in-patients enrolled in the study). The intervention dose varied between early dropouts (counseling sessions, M = 1.67) and study completers with some participants receiving a low dose (counseling sessions, M = 10.05) and high dose (counseling sessions, M = 25.37). Differences in the attendance groups were recognizable in the first two counseling sessions (duration of counseling session about 45 min in early dropouts versus 60 min for study completers). Fidelity of the in-person counseling content was partly achieved and adapted, whereas that of the remote counseling content was well achieved. Participants (86% at follow up) reported satisfaction with the implementers of the intervention. Adaptations were made to content, delivery mode and dose. Conclusion The PACINPAT trial was implemented in the intended population, in varying doses and with adaptations made to in-person counseling content and remote counseling dose. These findings are key to understanding outcome analyses within the PACINPAT trial, further developing interventions and contributing to implementation research among in-patients with depressive disorders. Trial registration ISRCTN, ISRCTN10469580 , registered on 3rd September 2018.

Abstract Background Rapid increases in caesarean section (CS) rates have been observed globally; however, CS rates exceeding 15% at a population-level have limited benefits for women and babies. Many interventions targeting healthcare providers have been developed to optimise use of CS, typically aiming to improve and monitor clinical decision-making. However, interventions are often complex, and effectiveness is varied. Understanding intervention and implementation features that likely lead to optimised CS use is important to optimise benefits. The aim of this study was to identify important components that lead to successful interventions to optimise CS, focusing on interventions targeting healthcare providers. Methods We used Qualitative Comparative Analysis (QCA) to identify if certain combination of important intervention features (e.g. type of intervention, contextual characteristics, and how the intervention was delivered) are associated with a successful intervention as reflected in a reduction of CS. We included 21 intervention studies targeting healthcare providers to reduce CS, comprising of 34 papers reporting on these interventions. To develop potential theories driving intervention success, we used existing published qualitative evidence syntheses on healthcare providers’ perspectives and experiences of interventions targeted at them to reduce CS. Results We identified five important components that trigger successful interventions targeting healthcare providers: 1) training to improve providers’ knowledge and skills, 2) active dissemination of CS indications, 3) actionable recommendations, 4) multidisciplinary collaboration, and 5) providers’ willingness to change. Importantly, when one or more of these components are absent, dictated nature of intervention, where providers are enforced to adhere to the intervention, is needed to prompt successful interventions. Unsuccessful interventions were characterised by the absence of these components. Conclusion We identified five important intervention components and combinations of intervention components which can lead to successful interventions targeting healthcare providers to optimise CS use. Health facility managers, researchers, and policy-makers aiming to improve providers’ clinical decision making and reduce CS may consider including the identified components to optimise benefits.

Background: Low birthweight and preterm birth rates are higher in the United States than in other developed countries and exhibit pronounced racial inequities. Home visiting is a strategy to promote equity in birth outcomes. Research points to precision home visiting as the path to equity. The purpose of this study is to describe local programs' risk reduction priorities, intended behavioral pathways, and expectations of home visitors; compare these local program features with those of their national model; and assess the strength of implementation systems to support staff in meeting job expectations. Methods: We surveyed local programs implementing one of four evidence-based home visiting models that aim to promote good birth outcomes: Family Spirit, Healthy Families America, Nurse-Family Partnership, and Parents as Teachers. Results: Representatives from 169 local programs completed the survey. Overall, 59% endorsed all their model's high priority risks, 16% endorsed all its required behavioral pathways, and 11% endorsed all its required techniques. Local programs went beyond their national model's explicit intentions. Overall, 91% of local programs prioritized risks beyond those of their model, 85% endorsed behavioral pathways beyond those of their model, 95% endorsed visitors' use of techniques not explicitly endorsed by their model but compatible with it, and 19% endorsed use of techniques judged incompatible by their model. Implementation system strength was positively associated with local program and model expectations. Conclusions: Precision home visiting to achieve health equity requires shared learning of what works best for whom. This observational study showed the Precision Paradigm's usefulness for cross-model research to advance precision. [ABSTRACT FROM AUTHOR]

In 2017, Tanzania was one of the countries in the world with the lowest proportion of households having access to improved toilets. Between 2017 and 2021, the government launched a national sanitation campaign under the brand Nyumba ni Choo. The objective of this paper is to assess the impact of one component of this campaign, "direct consumer contact" events, on the coverage of improved household latrines in Tanzania. Secondary data from both the National Sanitation Management Information System (NSMIS; https://nsmis.moh.go.tz/) and internal project reports were used to extract data on coverage and dates of events, respectively. Regression estimation models were used to estimate impact at ward and regional levels. The study used quarterly panel data from all 26 regions between 2017 (baseline) and 2020 (endline) for estimation purposes. The study shows that direct consumer contact events had a significant positive effect on the rate at which households subsequently improved their toilets at both small and large scale in Tanzania. On average, the rate of household latrine improvement increased by 12.91% at ward level and 14.17% at regional level. These results testify to the importance of designing an effective behavioral change campaign to achieve significant improvements in sanitation coverage. [ABSTRACT FROM AUTHOR]

Background: The physical activity counseling for in-patients with major depression (PACINPAT) randomized controlled trial was launched to tackle physical inactivity for in-patients with major depressive disorder. Evidence shows that despite potential treatment effects, physical inactivity is prevalent in this population. To contribute to the assessment of how this in-person and remote, theory-based, individually tailored intervention was designed, received and effected behavior, the aim of this study was to evaluate its implementation. Methods: This implementation evaluation was conducted within a multi-center randomized controlled trial according to the Process Evaluation Framework by the Medical Research Council including the analysis of reach, dose, fidelity and adaptation. Data were collected from the implementers and the participants randomized to the intervention group of the trial. Results: The study sample comprised 95 physically inactive in-patients (mean age: 42 years, 53% women) with diagnosed major depressive disorder. The intervention reached the intended population (N = 95 in-patients enrolled in the study). The intervention dose varied between early dropouts (counseling sessions, M = 1.67) and study completers with some participants receiving a low dose (counseling sessions, M = 10.05) and high dose (counseling sessions, M = 25.37). Differences in the attendance groups were recognizable in the first two counseling sessions (duration of counseling session about 45 min in early dropouts versus 60 min for study completers). Fidelity of the in-person counseling content was partly achieved and adapted, whereas that of the remote counseling content was well achieved. Participants (86% at follow up) reported satisfaction with the implementers of the intervention. Adaptations were made to content, delivery mode and dose. Conclusion: The PACINPAT trial was implemented in the intended population, in varying doses and with adaptations made to in-person counseling content and remote counseling dose. These findings are key to understanding outcome analyses within the PACINPAT trial, further developing interventions and contributing to implementation research among in-patients with depressive disorders. Trial registration: ISRCTN, ISRCTN10469580, registered on 3rd September 2018. [ABSTRACT FROM AUTHOR]

Background: Rapid increases in caesarean section (CS) rates have been observed globally; however, CS rates exceeding 15% at a population-level have limited benefits for women and babies. Many interventions targeting healthcare providers have been developed to optimise use of CS, typically aiming to improve and monitor clinical decision-making. However, interventions are often complex, and effectiveness is varied. Understanding intervention and implementation features that likely lead to optimised CS use is important to optimise benefits. The aim of this study was to identify important components that lead to successful interventions to optimise CS, focusing on interventions targeting healthcare providers. Methods: We used Qualitative Comparative Analysis (QCA) to identify if certain combination of important intervention features (e.g. type of intervention, contextual characteristics, and how the intervention was delivered) are associated with a successful intervention as reflected in a reduction of CS. We included 21 intervention studies targeting healthcare providers to reduce CS, comprising of 34 papers reporting on these interventions. To develop potential theories driving intervention success, we used existing published qualitative evidence syntheses on healthcare providers' perspectives and experiences of interventions targeted at them to reduce CS. Results: We identified five important components that trigger successful interventions targeting healthcare providers: 1) training to improve providers' knowledge and skills, 2) active dissemination of CS indications, 3) actionable recommendations, 4) multidisciplinary collaboration, and 5) providers' willingness to change. Importantly, when one or more of these components are absent, dictated nature of intervention, where providers are enforced to adhere to the intervention, is needed to prompt successful interventions. Unsuccessful interventions were characterised by the absence of these components. Conclusion: We identified five important intervention components and combinations of intervention components which can lead to successful interventions targeting healthcare providers to optimise CS use. Health facility managers, researchers, and policy-makers aiming to improve providers' clinical decision making and reduce CS may consider including the identified components to optimise benefits. [ABSTRACT FROM AUTHOR]

Abstract Background Many organizational interventions aim to improve working conditions to promote and protect worker safety, health, and well-being. The Workplace Organizational Health Study used process evaluation to examine factors influencing implementation of an organizational intervention. This paper examines the extent to which the intervention was implemented as planned, the dose of intervention implemented, and ways the organizational context hindered or facilitated the implementation of the intervention. Methods This proof-of-concept trial was conducted with a large, multinational company that provides food service through contractual arrangements with corporate clients. The 13-month intervention was launched in five intervention sites in October 2018. We report findings on intervention implementation based on process tracking and qualitative data. Qualitative data from 25 post-intervention interviews and 89 process tracking documents were coded and thematically analyzed. Results Over the 13-month intervention, research team representatives met with site managers monthly to provide consultation and technical assistance on safety and ergonomics, work intensity, and job enrichment. Approximately two-thirds of the planned in-person or phone contacts occurred. We tailored the intervention to each site as we learned more about context, work demands, and relationships. The research team additionally met regularly with senior leadership and district managers, who provided corporate resources and guidance. By assessing the context of the food service setting in which the intervention was situated, we explored factors hindering and facilitating the implementation of the intervention. The financial pressures, competing priorities and the fast-paced work environment placed constraints on site managers’ availability and limited the full implementation of the intervention. Conclusions Despite strong support from corporate senior leadership, we encountered barriers in the implementation of the planned intervention at the worksite and district levels. These included financial demands that drove work intensity; turnover of site and district managers disrupting continuity in the implementation of the intervention; and staffing constraints that further increased the work load and pace. Findings underscore the need for ongoing commitment and support from both the parent employer and the host client. Trial registration This study was retrospectively registered with the Clinical Trials. Gov Protocol and Results System on June 2, 2021 with assigned registration number NCT04913168 .

Abstract Background The Bridging the Age Gap in Breast Cancer research programme sought to improve treatment decision-making for older women with breast cancer by developing and testing, in a cluster randomised trial (n = 1339 patients), two decision support interventions (DESIs). Both DESIs were used in the intervention arm and each comprised an online risk prediction model, brief decision aid and information booklet. One DESI supported the decision to have either primary endocrine therapy (PET) or surgery with adjuvant therapies and the second supported the decision to have adjuvant chemotherapy after surgery or not. Methods Sixteen sites were randomly selected to take part in the process evaluation. Multiple methods of data collection were used. Medical Research Council (MRC) guidelines for the evaluation of complex interventions were used. Results Eighty-two patients, mean age 75.5 (range 70–93), provided data for the process evaluation. Seventy-three interviews were completed with patients. Ten clinicians from six intervention sites took part in telephone interviews. Dose: Ninety-one members of staff in the intervention arm received intervention training. Reach: The online tool was accessed on 324 occasions by 27 clinicians. Reasons for non-use of the online tool were commonly that the patient had already made a decision or that there was no online access in the clinic. Of the 32 women for whom there were data available, fifteen from the intervention arm and six from the usual care arm were offered a choice of treatment. Fidelity: Clinicians used the online tool in different ways, with some using it during the consultation and others checking the online survival estimates before the consultation. Adaptation: There was evidence of adaptation when using the DESIs. A lack of infrastructure, e.g. internet access, was a barrier to the use of the online tool. The brief decision aid was rarely used. Mediators: Shared decision-making: Most patients felt able to contribute to decision-making and expressed high levels of satisfaction with the process. Participants’ responses to intervention: Six patients reported the DESIs to be very useful, one somewhat useful and two moderately useful. Conclusions Clinicians who participated were mainly supportive of the interventions and had attempted some adaptations to make the interventions applicable, but there were practical and engagement barriers that led to sub-optimal adoption in routine practice. Trial registration ISRCTN46099296 . Registered on 11 August 2016—retrospectively registered

Abstract Background Adherence to heart failure (HF) self-care behaviours has been found to be effective for alleviating illness symptoms, increasing quality of life and reducing hospital re-admissions and mortality. However, many patients fail to implement on-going self-care into their daily lives. It is therefore crucial to improve the behaviour of HF patients to increase self-care adherence. The aim of this study is to identify relevant factors to successfully implement a complex, theory-based HF self-care intervention into routine practice. Methods We conducted semi-structured interviews to obtain key stakeholders’ opinions on previously developed behaviour change techniques for enhancing HF patients’ self-care behaviours, in order to optimise implementation of these techniques in an intervention. The interview topic guide was developed based on the Normalisation Process Theory (NPT), a tool that takes into account the feasibility of implementation and the acceptability to stakeholders. Interviews were analysed using thematic analysis and supported by MAXQDA 2020, a software for qualitative research. Results Interview participants included 18 key stakeholders consisting of three crucial groups: clinical experts (n = 7), patients (n = 3) and high calibre policy makers/potential funders (n = 8). The interviews revealed numerous factors to consider for successful implementation of an intervention into routine practice. The findings are presented according to two major categories: (1) themes within the NPT framework and (2) themes beyond the NPT framework. Themes within the NPT component ‘Coherence’ include three sub-themes: ‘understandability’, ‘value beyond existing interventions’ and ‘perceived benefits’. The NPT component ‘Cognitive participation’ revealed two sub-themes: ‘time resources’ and ‘financial sustainability’. Finally, the NPT component ‘Collective action’ uncovered three sub-themes: ‘need for training’, ‘compatibility with existing practice’ and ‘influence on roles’. A further two themes were identified beyond the NPT framework, namely: ‘structural challenges’ and (2) ‘role of carers’. Conclusions Factors identified previously by NPT were validated, but stakeholders further identified relevant aspects beyond NPT. Based on these findings, we suggest the existing NPT framework could be expanded to include a fifth component: questions considering specific environmental factors (contextual considerations). Sensitising researchers to these issues at an early stage when designing an intervention can facilitate its later success.

The established relationship between poverty and tuberculosis has led to the implementation of complex socioeconomic interventions to address poverty as both a risk factor for and consequence of tuberculosis. However, limited research to date has examined the conditions that facilitate the successful implementation of these interventions. We conducted a systematic realist review to examine how complex socioeconomic interventions for tuberculosis treatment and care were defined, implemented, and evaluated in low- and middle-income countries. We used a systematic search to identify published work that implemented complex socioeconomic interventions for tuberculosis, followed by a realist analysis informed by existing programme theories. From a total of 2825 collected records, 36 peer-reviewed articles and 17 grey literature reports were included in this review. The realist analysis identified three main contexts (sociopolitical and cultural; relational and interpersonal; operational and administrative) and ten mechanisms that facilitated successful implementation of interventions. Overall, this review highlights the importance of political commitment in shaping sustainable programme delivery, the role of healthcare and community-based provider training in creating patient-centred treatment environments, and the opportunity to leverage operational research for evidence-based decision making to address the socioeconomic needs of tuberculosis patients experiencing poverty. [ABSTRACT FROM AUTHOR]

Objectives: The first year of care, post diagnosis, is pivotal for children and young people diagnosed with type 1 diabetes. This study evaluated a paediatric type 1 diabetes intervention, the ‘First Year of Care’, designed to maximise the care that newly diagnosed children and young people received. Study design: An observational mixed methods approach, underpinned by the Influencer Framework. Methods: A purposeful, non-probability sample of children and young people with type 1 diabetes and their families, and healthcare professionals were invited to take part. Data were collected through medical records of thirty-two newly diagnosed children and young people, plus thirty seven semi-structured interviews and exposure to six concurrent sources of influence through a questionnaire. Results: For many participants, HbA1c levels were within the optimal range by the time of their first clinic visit post-diagnosis and continued to stay within this range throughout the first year of care. Healthcare professionals prioritised the ‘First Year of Care’ intervention. Positive practices included: a cohesive and collaborative approach; patient-centred care; latest health technology and embedded structured education. Unusually, different multidisciplinary team members were located in one place.Data indicated statistically significant differences in total sources of influence score (t [35] = 2.331, p = 0.026); healthcare professionals’ scores were higher compared to children. This suggests that children and young people have less social capital to self-manage their diabetes effectively. Greater encouragement and assistance from healthcare professionals and social networks may be needed. Conclusions: This paper identifies contemporary issues in practice and highlights the strengths and challenges for a paediatric diabetes intervention. The findings confirm the potential of layered approaches to behaviour change in managing type 1 diabetes across multiple domains of influence. Our study strongly suggests enhancing social motivation among children, young people and families to support successful long-term engagement in a paediatric diabetes intervention. Findings demonstrate healthcare professionals are key in delivering the intervention, along with opportunities to improve patient care, experience and outcomes.

Transitioning Together is a multi-family intervention designed to support families of adolescents on the autism spectrum as they prepare for the transition to adulthood. Questions remain regarding its wide-scale adoption and implementation in real-world settings such as high schools. We examined student, teacher, and school-level facilitators and barriers to adopting and implementing Transitioning Together at 30 public high schools across three US states that were participating in the intervention arm of a larger randomized trial, which provided training and coaching for implementation of comprehensive evidence-based autism programming. Seventeen of the 30 schools adopted Transitioning Together. Community socioeconomic status and pre-existing quality of programming for family involvement and transition planning significantly predicted intervention adoption. Thirteen of the 17 schools that adopted Transitioning Together did so with a high level of fidelity (>90%). The areas of fidelity that schools struggled with most related to session structure, facilitating problem-solving and dialogue, and collecting feedback from families. Findings highlight struggles and successes with real-world adoption of the intervention in its current form. Future research is needed to further examine how to facilitate adoption across public high schools and/or other service systems, while maximizing effectiveness, as well as reach to historically underserved autism spectrum populations. Transitioning Together is an intervention that supports families of adolescents on the autism spectrum as they prepare for the transition to adulthood. While it has been delivered successfully and shown to result in positive outcomes for families in the university setting, questions remain about whether and how well it can be widely provided to families in real-world settings such as high schools. In this study, we analyzed predictors, facilitators, and barriers to providing Transitioning Together to families at 30 high schools across three US states, all of which received training from a team of researchers to deliver this intervention. Our findings highlight struggles and successes with real-world use of the intervention. Seventeen of the 30 schools were successful in providing Transitioning Together to families. Schools who had higher community socioeconomic status, higher quality family involvement, and higher quality transition planning programming before changing anything for this study were much more likely to provide this new intervention to families. Schools who used the intervention were mostly able to deliver it as designed and received positive feedback from families who participated. Common parts of the intervention that schools struggled with most included following the structure of the sessions, including group problem-solving and dialogue in the sessions, and collecting feedback from families. Future research is needed to learn how to make it even easier for public high schools and other service systems to provide this intervention to families, in a way that also maximizes its effectiveness and accessibility for historically underserved autism spectrum populations. [ABSTRACT FROM AUTHOR]

Abstract Background The NHS Diabetes Prevention Programme (NHS-DPP) is a nine-month, group-based behavioural intervention for adults in England at risk of developing Type 2 diabetes. Four independent providers were commissioned to deliver versions of the NHS-DPP, in line with NHS England specifications. This observational study maps NHS-DPP delivery in routine practice against the NHS specification, and compares service delivery with observed patient experiences. Methods Researchers observed service delivery across eight complete NHS-DPP courses (118 sessions, median 14 sessions per course), consenting 455 participants (36 staff, 398 patients, 21 accompanying persons). Key features of NHS-DPP delivery were described using the Template for Intervention Description and Replication (TIDieR) framework. Researchers wrote detailed field notes during each session, including observations of patient experience. Field notes were content analysed; instances of positive and negative experiences were labelled and grouped into categories. Researchers used a novel method of comparing observed patient experiences to variations in programme delivery. Results Delivery broadly followed NHS England’s specification and the plans set out by providers. Deviations included the scheduling and larger group sizes in some sessions. There was variation in the type and format of activities delivered by providers. Positive patient experiences included engagement, satisfaction with the programme, good within-group relationships and reported behavioural changes. Negative experiences included poor scheduling, large groups, and dissatisfaction with the venue. Where more interactive and visual activities were delivered in smaller groups of 10–15 people with good rapport, there were generally more instances of positive patient experiences, and where there were structural issues such as problems with the scheduling of sessions, poor venues and inadequate resources, there tended to be more negative patient experiences. Conclusions Addressing issues that we have identified as being linked to negative experiences with the NHS-DPP could increase uptake, reduce patient drop-out and increase the overall effectiveness of the programme. In particular, modifying structural aspects of the NHS-DPP (e.g. reliable session scheduling, reducing group sizes, enough session resources) and increasing interaction appear particularly promising for improving these outcomes.

Objectives: To explore in‐depth the views on Internet‐based psychological therapies and their implementation from the perspective of National Health Service (NHS) commissioners and managers. Design: Qualitative interview study. Method: Ten NHS commissioners and managers participated in a semi‐structured, co‐produced interview. Each transcribed interview was double‐coded and thematically analysed using The Framework Method. Results: Interviews generated three main themes. (1) Capacity issues across psychological therapy services create barriers to face‐to‐face therapies, and Internet‐based interventions offer a solution. (2) Despite reservations, there is growing acceptance of Internet‐based therapies. Different ways of connecting with patients are required, and Internet‐based treatments are accessible and empowering treatment options, with guided self‐help (GSH) preferred. Internet‐based interventions may however exclude some individuals and be a threat to the therapeutic relationship between patient and practitioner. (3) Successful roll‐out of Internet‐based interventions would be facilitated by a strong empirical‐ or practice‐based evidence, a national coordinated approach and timely training and supervision. Barriers to the roll‐out include digital intervention set‐up costs and delays due to NHS inflexibility. Conclusions: The study highlights factors influencing access to Internet‐based therapies, important given the rapid evolution of e‐therapies, and particularly timely given increasing use of remote therapies due to COVID‐19 restrictions. Interviewees were open to Internet‐based approaches, particularly GSH interventions, so long as they do not compromise on therapy quality. Interviewees acknowledged implementation may be challenging, and recommendations were offered. Practitioner points: There is a shift in practice and increasingly positive views from NHS staff around remote psychological therapies and different ways of connecting with patients, particularly since the COVID‐19 pandemic.There is a strong preference for Internet‐based psychological interventions that are guided and that include built‐in outcome measures co‐produced with service users.There is a need to raise awareness of the growing evidence base for Internet‐based psychological therapies, including research examining therapeutic alliance across Internet‐based and face‐to‐face therapies.Challenges implementing Internet‐based psychological therapies include therapist resistance to changing working practices in general, and inflexibility of the NHS, and national, coordinated implementation efforts are encouraged. [ABSTRACT FROM AUTHOR]

Background Despite common use, anticholinergic medications have been associated with serious health risks. Interventions to reduce their use are being developed and there is a need to understand their implementation into clinical care. Aim of review This systematic review aims to identify and analyse qualitative research studies exploring the barriers and facilitators to reducing anticholinergic burden. Methods Medline (OVID), EMBASE (OVID), CINAHL (EMBSCO) and PsycINFO (OVID) were searched using comprehensive search terms. Peer reviewed studies published in English presenting qualitative research in relation to the barriers and facilitators of deprescribing anticholinergic medications, involving patients, carers or health professionals were eligible. Normalization Process Theory was used to explore and explain the data. Results Of 1764 identified studies, two were eligible and both involved healthcare professionals (23 general practitioners, 13 specialist clinicians and 12 pharmacists). No studies were identified that involved patients or carers. Barriers to collaborative working often resulted in poor motivation to reduce anticholinergic use. Low confidence, system resources and organisation of care also hindered anticholinergic burden reduction. Good communication and relationships with patients, carers and other healthcare professionals were reported as important for successful anticholinergic burden reduction. Having a named person for prescribing decisions, and clear role boundaries, were also important facilitators. Conclusions This review identified important barriers and facilitators to anticholinergic burden reduction from healthcare provider perspectives which can inform implementation of such deprescribing interventions. Studies exploring patient and carer perspectives are presently absent but are required to ensure person-centeredness and feasibility of future interventions. [ABSTRACT FROM AUTHOR]

Background: Many organizational interventions aim to improve working conditions to promote and protect worker safety, health, and well-being. The Workplace Organizational Health Study used process evaluation to examine factors influencing implementation of an organizational intervention. This paper examines the extent to which the intervention was implemented as planned, the dose of intervention implemented, and ways the organizational context hindered or facilitated the implementation of the intervention.Methods: This proof-of-concept trial was conducted with a large, multinational company that provides food service through contractual arrangements with corporate clients. The 13-month intervention was launched in five intervention sites in October 2018. We report findings on intervention implementation based on process tracking and qualitative data. Qualitative data from 25 post-intervention interviews and 89 process tracking documents were coded and thematically analyzed.Results: Over the 13-month intervention, research team representatives met with site managers monthly to provide consultation and technical assistance on safety and ergonomics, work intensity, and job enrichment. Approximately two-thirds of the planned in-person or phone contacts occurred. We tailored the intervention to each site as we learned more about context, work demands, and relationships. The research team additionally met regularly with senior leadership and district managers, who provided corporate resources and guidance. By assessing the context of the food service setting in which the intervention was situated, we explored factors hindering and facilitating the implementation of the intervention. The financial pressures, competing priorities and the fast-paced work environment placed constraints on site managers' availability and limited the full implementation of the intervention.Conclusions: Despite strong support from corporate senior leadership, we encountered barriers in the implementation of the planned intervention at the worksite and district levels. These included financial demands that drove work intensity; turnover of site and district managers disrupting continuity in the implementation of the intervention; and staffing constraints that further increased the work load and pace. Findings underscore the need for ongoing commitment and support from both the parent employer and the host client.Trial Registration: This study was retrospectively registered with the Clinical Trials. Gov Protocol and Results System on June 2, 2021 with assigned registration number NCT04913168 . [ABSTRACT FROM AUTHOR]

Values‐affirmation interventions have the potential to improve students' experience and achievement in school. Researchers have proposed that these benefits are greatest when affirmation exercises are delivered by teachers (versus researchers). The current research provides an experimental test of whether describing affirmation activities as provided by teachers increases students' engagement with the activities and students' positive perceptions of their teachers. In a 2×2 field experiment, delivered to students during their first year of high school, students completed either an affirmation or matched control activity purportedly provided by either teachers or researchers. We found that describing affirmation activities as provided by teachers led students to perceive that teachers at their school were more interested in students' broader lives outside of school and provided marginally more care and support to students, as compared to the same affirmation exercise described as provided by researchers and control activities attributed to either source. In addition, teacher‐provided affirmation activities prompted students to write more during the activities. The present study provides initial evidence that affirmation interventions can improve students' perceptions of their relationship with their teachers—a potent driver of student success—but only when affirmation activities are seen as coming from and of interest to teachers. [ABSTRACT FROM AUTHOR]

Abstract Background Engaging and retaining young men in community-based interventions is highly challenging. The purpose of this study was to investigate the individual factors that predict intervention engagement and adherence in a sample of at-risk South African men. Methods Baseline data were collected as a part of a cluster randomised control trial (RCT) situated in Khayelitsha and Mfuleni, two peri-urban settlements situated on the outskirts of Cape Town, South Africa. Neighbourhoods were randomised to one of three intervention conditions. We performed univariate descriptive statistics to report neighbourhood and individual socio-demographic factors, and ran multivariate models, adjusting for entry of study, to determine if high adherence and consistency of engagement with the intervention were associated with socio-behavioural demographics and risk behaviours, such as hazardous substance use, gangsterism, and criminal activity. Results Total of 729 men were on average 22.5 years old (SD 2.8), with a mean of 10 years of education. More than half of the sample were single (94%), lived with their parents (66%) and had an income below ~$30 (52%). The overall mean of adherence is 0.41 (SD 0.24) and mean of consistency of engagement is 0.61 (SD 0.30). Our data indicated that completing more years of education, living with parents, and having higher socioeconomic status were significantly associated with higher rates of engagement and adherence. Men with a history of gang membership demonstrated higher levels of adherence and consistent engagement with the intervention, compared with other men who were recruited to the intervention. Crucially, our data show that young men with a history of substance use, and young men who report symptoms of depression and high levels of perceived stress are equally likely as other young men to adhere to the intervention and attend intervention sessions consistently. Conclusion Our results may contribute to a better understanding of young men’s patterns of engagement and adherence to public health interventions. The results may have important implications for policy and practice, as they may be useful in planning more effective interventions and could potentially be used to predict which young men can be reached through community-based interventions. Trial registration ClinicalTrials.gov registration, NCT02358226. Prospectively registered 24 November 2014.

Abstract Background Psychosocial interventions offer opportunities to improve care for people with dementia in care homes. However, implementation is often led by staff who are not well prepared for the role. Some interventions use external experts to support staff. However little is known about external expert, care home staff and manager perceptions of such support. This paper addresses this gap. Methods Multi-methods study within a process evaluation of a cluster randomised controlled trial of Dementia Care Mapping™ (DCM). Interviews were conducted with six external experts who also completed questionnaires, 17 care home managers and 25 care home staff responsible for DCM implementation. Data were analysed using descriptive statistics and template analysis. Results Three themes were identified: the need for expert support, practicalities of support and broader impacts of providing support. Expert support was vital for successful DCM implementation, although the five-days provided was felt to be insufficient. Some homes felt the support was inflexible and did not consider their individual needs. Practical challenges of experts being located at a geographical distance from the care homes, limited when and how support was available. Experts gained knowledge they were able to then apply in delivering DCM training. Experts were not able to accurately predict which homes would be able to implement DCM independently in future cycles. Conclusions An external expert may form a key component of successful implementation of psychosocial interventions in care home settings. Future research should explore optimal use of the expert role.

Background: The Bridging the Age Gap in Breast Cancer research programme sought to improve treatment decision-making for older women with breast cancer by developing and testing, in a cluster randomised trial (n = 1339 patients), two decision support interventions (DESIs). Both DESIs were used in the intervention arm and each comprised an online risk prediction model, brief decision aid and information booklet. One DESI supported the decision to have either primary endocrine therapy (PET) or surgery with adjuvant therapies and the second supported the decision to have adjuvant chemotherapy after surgery or not.Methods: Sixteen sites were randomly selected to take part in the process evaluation. Multiple methods of data collection were used. Medical Research Council (MRC) guidelines for the evaluation of complex interventions were used.Results: Eighty-two patients, mean age 75.5 (range 70-93), provided data for the process evaluation. Seventy-three interviews were completed with patients. Ten clinicians from six intervention sites took part in telephone interviews. Dose: Ninety-one members of staff in the intervention arm received intervention training. Reach: The online tool was accessed on 324 occasions by 27 clinicians. Reasons for non-use of the online tool were commonly that the patient had already made a decision or that there was no online access in the clinic. Of the 32 women for whom there were data available, fifteen from the intervention arm and six from the usual care arm were offered a choice of treatment. Fidelity: Clinicians used the online tool in different ways, with some using it during the consultation and others checking the online survival estimates before the consultation. Adaptation: There was evidence of adaptation when using the DESIs. A lack of infrastructure, e.g. internet access, was a barrier to the use of the online tool. The brief decision aid was rarely used. Mediators: Shared decision-making: Most patients felt able to contribute to decision-making and expressed high levels of satisfaction with the process. Participants' responses to intervention: Six patients reported the DESIs to be very useful, one somewhat useful and two moderately useful.Conclusions: Clinicians who participated were mainly supportive of the interventions and had attempted some adaptations to make the interventions applicable, but there were practical and engagement barriers that led to sub-optimal adoption in routine practice.Trial Registration: ISRCTN46099296 . Registered on 11 August 2016-retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Adherence to heart failure (HF) self-care behaviours has been found to be effective for alleviating illness symptoms, increasing quality of life and reducing hospital re-admissions and mortality. However, many patients fail to implement on-going self-care into their daily lives. It is therefore crucial to improve the behaviour of HF patients to increase self-care adherence. The aim of this study is to identify relevant factors to successfully implement a complex, theory-based HF self-care intervention into routine practice.Methods: We conducted semi-structured interviews to obtain key stakeholders' opinions on previously developed behaviour change techniques for enhancing HF patients' self-care behaviours, in order to optimise implementation of these techniques in an intervention. The interview topic guide was developed based on the Normalisation Process Theory (NPT), a tool that takes into account the feasibility of implementation and the acceptability to stakeholders. Interviews were analysed using thematic analysis and supported by MAXQDA 2020, a software for qualitative research.Results: Interview participants included 18 key stakeholders consisting of three crucial groups: clinical experts (n = 7), patients (n = 3) and high calibre policy makers/potential funders (n = 8). The interviews revealed numerous factors to consider for successful implementation of an intervention into routine practice. The findings are presented according to two major categories: (1) themes within the NPT framework and (2) themes beyond the NPT framework. Themes within the NPT component 'Coherence' include three sub-themes: 'understandability', 'value beyond existing interventions' and 'perceived benefits'. The NPT component 'Cognitive participation' revealed two sub-themes: 'time resources' and 'financial sustainability'. Finally, the NPT component 'Collective action' uncovered three sub-themes: 'need for training', 'compatibility with existing practice' and 'influence on roles'. A further two themes were identified beyond the NPT framework, namely: 'structural challenges' and (2) 'role of carers'.Conclusions: Factors identified previously by NPT were validated, but stakeholders further identified relevant aspects beyond NPT. Based on these findings, we suggest the existing NPT framework could be expanded to include a fifth component: questions considering specific environmental factors (contextual considerations). Sensitising researchers to these issues at an early stage when designing an intervention can facilitate its later success. [ABSTRACT FROM AUTHOR]

Abstract Background Context matters for the successful implementation of medical interventions, but its role remains surprisingly understudied. Against the backdrop of antimicrobial resistance, a global health priority, we investigated the introduction of a rapid diagnostic biomarker test (C-reactive protein, or CRP) to guide antibiotic prescriptions in outpatient settings and asked, “Which factors account for cross-country variations in the effectiveness of CRP biomarker test interventions?” Methods We conducted a cross-case comparison of CRP point-of-care test trials across Yangon (Myanmar), Chiang Rai (Thailand), and Hanoi (Vietnam). Cross-sectional qualitative data were originally collected as part of each clinical trial to broaden their evidence base and help explain their respective results. We synthesised these data and developed a large qualitative data set comprising 130 interview and focus group participants (healthcare workers and patients) and nearly one million words worth of transcripts and interview notes. Inductive thematic analysis was used to identify contextual factors and compare them across the three case studies. As clinical trial outcomes, we considered patients’ and healthcare workers’ adherence to the biomarker test results, and patient exclusion to gauge the potential “impact” of CRP point-of-care testing on the population level. Results We identified three principal domains of contextual influences on intervention effectiveness. First, perceived risks from infectious diseases influenced the adherence of the clinical users (nurses, doctors). Second, the health system context related to all three intervention outcomes (via the health policy and antibiotic policy environment, and via health system structures and the ensuing utilisation patterns). Third, the demand-side context influenced the patient adherence to CRP point-of-care tests and exclusion from the intervention through variations in local healthcare-seeking behaviours, popular conceptions of illness and medicine, and the resulting utilisation of the health system. Conclusions Our study underscored the importance of contextual variation for the interpretation of clinical trial findings. Further research should investigate the range and magnitude of contextual effects on trial outcomes through meta-analyses of large sets of clinical trials. For this to be possible, clinical trials should collect qualitative and quantitative contextual information for instance on their disease, health system, and demand-side environment. Trial registration ClinicalTrials.gov, NCT02758821 registered on 3 May 2016 and NCT01918579 registered on 7 August 2013.

Abstract Background The implementation of multiple health behaviour change interventions for cardiovascular risk reduction in primary care is suboptimal. This study aimed to identify barriers and facilitators to implementing multiple health behaviour change interventions for cardiovascular disease (CVD) risk reduction in primary care. Methods Qualitative study using semi-structured interviews informed by the Theoretical Domains Framework. Interviews were conducted with a purposive sample of healthcare professionals working in the implementation of the NHS Health Check programme in London. Data were analysed using the Framework method. Results Thirty participants were recruited including ten general practitioners, ten practice nurses, seven healthcare assistants and three practice managers from 23 practices. Qualitative analysis identified three main themes: healthcare professionals’ conceptualising health behaviour change; delivering multiple health behaviour change interventions in primary care; and delivering the health check programme. Healthcare professionals generally recognised the importance of health behaviour change for CVD risk reduction but were more sceptical about the potential for successful intervention through primary care. Participants identified the difficulty of sustained behaviour change for patients, the lack of evidence for effective interventions and limited access to appropriate resources in primary care as barriers. Discussing changing multiple health behaviours was perceived to be overwhelming for patients and difficult to implement for healthcare professionals with current primary care resources. The health check programme consists of several components that are difficult to fully complete in limited time. Conclusions Advancing the prevention agenda will require strategies to support the delivery of behaviour change interventions in primary care. Greater emphasis needs to be given to promoting behaviour change through supportive environmental context. Further research is needed to evaluate current external lifestyle services to improve the intervention outcomes.