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Abstract Background Hip osteoarthritis (OA) is a leading cause of chronic pain and disability worldwide. Self-management is vital with education, exercise and weight loss core recommended treatments. However, evidence-practice gaps exist, and service models that increase patient accessibility to clinicians who can support lifestyle management are needed. The primary aim of this study is to determine the effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program (Better Hip) on the primary outcomes of hip pain on walking and physical function at 6 months, compared with an information-only control for people with hip OA. Methods A two-arm, parallel-design, superiority pragmatic randomised controlled trial. 212 members from a health insurance fund aged 45 years and over, with painful hip OA will be recruited. Participants will be randomly allocated to receive: i) Better Hip; or ii) web-based information only (control). Participants randomised to the Better Hip program will have six videoconferencing physiotherapist consultations for education about OA, prescription of individualised home-based strengthening and physical activity programs, behaviour change support, and facilitation of other self-management strategies. Those with a body mass index > 27 kg/m2, aged

Abstract Background Disentangling the interplay between experience-based intuition and theory-informed implementation is crucial for identifying the direct contribution theory can make for generating behaviour changes needed for successful evidence translation. In the context of ‘clinicogenomics’, a complex and rapidly evolving field demanding swift practice change, we aimed to (a) describe a combined clinician intuition- and theory-driven method for identifying determinants of and strategies for implementing clinicogenomics, and (b) articulate a structured approach to standardise hypothesised behavioural pathways and make potential underlying theory explicit. Methods Interview data from 16 non-genetic medical specialists using genomics in practice identified three target behaviour areas across the testing process: (1) identifying patients, (2) test ordering and reporting, (3) communicating results. The Theoretical Domains Framework (TDF) was used to group barriers and facilitators to performing these actions. Barriers were grouped by distinct TDF domains, with ‘overarching’ TDF themes identified for overlapping barriers. Clinician intuitively-derived implementation strategies were matched with corresponding barriers, and retrospectively coded against behaviour change techniques (BCTs). Where no intuitive strategies were provided, theory-driven strategies were generated. An algorithm was developed and applied to articulate how implementation strategies address barriers to influence behaviour change. Results Across all target behaviour areas, 32 identified barriers were coded across seven distinct TDF domains and eight overarching TDF themes. Within the 29 intuitive strategies, 21 BCTs were represented and used on 49 occasions to address 23 barriers. On 10 (20%) of these occasions, existing empirical links were found between BCTs and corresponding distinct TDF-coded barriers. Twenty additional theory-driven implementation strategies (using 19 BCTs on 31 occasions) were developed to address nine remaining barriers. Conclusion Clinicians naturally generate their own solutions when implementing clinical interventions, and in this clinicogenomics example these intuitive strategies aligned with theoretical recommendations 20% of the time. We have matched intuitive strategies with theory-driven BCTs to make potential underlying theory explicit through proposed structured hypothesised causal pathways. Transparency and efficiency are enhanced, providing a novel method to identify determinants of implementation. Operationalising this approach to support the design of implementation strategies may optimise practice change in response to rapidly evolving scientific advances requiring swift translation into healthcare.

Abstract Background Older people living in residential aged care facilities are at high risk of acquiring infections such as influenza, gastroenteritis, and more recently COVID-19. These infections are a major cause of morbidity and mortality among this cohort. Quality infection prevention and control practice in residential aged care is therefore imperative. Although appointment of a dedicated infection prevention and control (IPC) lead in every Australian residential aged care facility is now mandated, all people working in this setting have a role to play in IPC. The COVID-19 pandemic revealed inadequacies in IPC in this sector and highlighted the need for interventions to improve implementation of best practice. Methods Using mixed methods, this four-phase implementation study will use theory-informed approaches to: (1) assess residential aged care facilities’ readiness for IPC practice change, (2) explore current practice using scenario-based assessments, (3) investigate barriers to best practice IPC, and (4) determine and evaluate feasible and locally tailored solutions to overcome the identified barriers. IPC leads will be upskilled and supported to operationalise the selected solutions. Staff working in residential aged care facilities, residents and their families will be recruited for participation in surveys and semi-structured interviews. Data will be analysed and triangulated at each phase, with findings informing the subsequent phases. Stakeholder groups at each facility and the IMMERSE project’s Reference Group will contribute to the interpretation of findings at each phase of the project. Discussion This multi-site study will comprehensively explore infection prevention and control practices in residential aged care. It will inform and support locally appropriate evidence-based strategies for enhancing infection prevention and control practice.

Abstract Introduction Arthroplasty is an effective, yet costly, surgical procedure for end‐stage osteoarthritis. Shorter stays in hospital are being piloted in Australia. In some countries, short stay is established practice, associated with improving perioperative care and enhanced recovery after surgery practices. Exploring the acceptability to patients of a short stay care pathway in hospital postarthroplasty is important for informing health policy, adoption and potential scalability of this model of care. Methods Consecutive patients at one site, at least 3 months post total joint arthroplasty, were invited to participate in theory‐informed semi‐structured qualitative interviews. The Theoretical Framework of Acceptability (TFA) informed development of the interview guide. Interview data were analysed using the Framework Method. Results Eighteen patients were invited. Fifteen consented to be contacted and were interviewed. Short‐stay post arthroplasty was highly acceptable to patients who had the supports necessary to recover safely at home. Key findings were as follows: flexibility of short‐stay care pathway was essential and valued; prior beliefs and expectations informed acceptability; and the absence of out‐of‐pocket expenses had an incentivizing effect, but was not the primary reason for patients choosing this care pathway. Further themes analysed within the TFA constructs highlighted nuances of acceptability relating to this model of care. Conclusions A short stay in hospital post arthroplasty appeared to be acceptable to patients who had experienced this care pathway. Our thematic findings identified aspects of the short‐stay care pathway that enhanced acceptability and some aspects that limited acceptability. These findings can inform refinement of the short‐stay care pathway. Patient or Public Contribution Patients/people with lived experience were not involved in the study design or conduct of this preliminary work; as this short‐stay model of care was recently introduced, only a small group of patients was eligible to participate in this study. This study is the first step towards understanding the experiences of patients about a short‐stay model of care post arthroplasty. The findings will help inform future patient and public involvement in expanding the programme.

Abstract Background The theoretical framework of acceptability (TFA) was developed in response to recommendations that acceptability should be assessed in the design, evaluation and implementation phases of healthcare interventions. The TFA consists of seven component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy) that can help to identify characteristics of interventions that may be improved. The aim of this study was to develop a generic TFA questionnaire that can be adapted to assess acceptability of any healthcare intervention. Methods Two intervention-specific acceptability questionnaires based on the TFA were developed using a 5-step pre-validation method for developing patient-reported outcome instruments: 1) item generation; 2) item de-duplication; 3) item reduction and creation; 4) assessment of discriminant content validity against a pre-specified framework (TFA); 5) feedback from key stakeholders. Next, a generic TFA-based questionnaire was developed and applied to assess prospective and retrospective acceptability of the COVID-19 vaccine. A think-aloud method was employed with two samples: 10 participants who self-reported intention to have the COVID-19 vaccine, and 10 participants who self-reported receiving a first dose of the vaccine. Results 1) The item pool contained 138 items, identified from primary papers included in an overview of reviews. 2) There were no duplicate items. 3) 107 items were discarded; 35 new items were created to maximise coverage of the seven TFA constructs. 4) 33 items met criteria for discriminant content validity and were reduced to two intervention-specific acceptability questionnaires, each with eight items. 5) Feedback from key stakeholders resulted in refinement of item wording, which was then adapted to develop a generic TFA-based questionnaire. For prospective and retrospective versions of the questionnaire, no participants identified problems with understanding and answering items reflecting four TFA constructs: affective attitude, burden, perceived effectiveness, opportunity costs. Some participants encountered problems with items reflecting three constructs: ethicality, intervention coherence, self-efficacy. Conclusions A generic questionnaire for assessing intervention acceptability from the perspectives of intervention recipients was developed using methods for creating participant-reported outcome measures, informed by theory, previous research, and stakeholder input. The questionnaire provides researchers with an adaptable tool to measure acceptability across a range of healthcare interventions.

Abstract Background Acute low back pain is a common condition, has high burden, and there are evidence-to-practice gaps in the chiropractic and physiotherapy setting for imaging and giving advice to stay active. The aim of this cluster randomised trial was to estimate the effects of a theory- and evidence-based implementation intervention to increase chiropractors’ and physiotherapists’ adherence to a guideline for acute low back pain compared with the comparator (passive dissemination of the guideline). In particular, the primary aim of the intervention was to reduce inappropriate imaging referral and improve patient low back pain outcomes, and to determine whether this intervention was cost-effective. Methods Physiotherapy and chiropractic practices in the state of Victoria, Australia, comprising at least one practising clinician who provided care to patients with acute low back pain, were invited to participate. Patients attending these practices were included if they had acute non-specific low back pain (duration less than 3 months), were 18 years of age or older, and were able to understand and read English. Practices were randomly assigned either to a tailored, multi-faceted intervention based on the guideline (interactive educational symposium plus academic detailing) or passive dissemination of the guideline (comparator). A statistician independent of the study team undertook stratified randomisation using computer-generated random numbers; four strata were defined by professional group and the rural or metropolitan location of the practice. Investigators not involved in intervention delivery were blinded to allocation. Primary outcomes were X-ray referral self-reported by clinicians using a checklist and patient low back pain-specific disability (at 3 months). Results A total of 104 practices (43 chiropractors, 85 physiotherapists; 755 patients) were assigned to the intervention and 106 practices (45 chiropractors, 97 physiotherapists; 603 patients) to the comparator; 449 patients were available for the patient-level primary outcome. There was no important difference in the odds of patients being referred for X-ray (adjusted (Adj) OR: 1.40; 95% CI 0.51, 3.87; Adj risk difference (RD): 0.01; 95% CI − 0.02, 0.04) or patient low back pain-specific disability (Adj mean difference: 0.37; 95% CI − 0.48, 1.21, scale 0–24). The intervention did lead to improvement for some key secondary outcomes, including giving advice to stay active (Adj OR: 1.96; 95% CI 1.20, 3.22; Adj RD: 0.10; 95% CI 0.01, 0.19) and intending to adhere to the guideline recommendations (e.g. intention to refer for X-ray: Adj OR: 0.27; 95% CI 0.17, 0.44; intention to give advice to stay active: Adj OR: 2.37; 95% CI 1.51, 3.74). Conclusions Intervention group clinicians were more likely to give advice to stay active and to intend to adhere to the guideline recommendations about X-ray referral. The intervention did not change the primary study outcomes, with no important differences in X-ray referral and patient disability between groups, implying that hypothesised reductions in health service utilisation and/or productivity gains are unlikely to offset the direct costs of the intervention. We report these results with the caveat that we enrolled less patients into the trial than our determined sample size. We cannot recommend this intervention as a cost-effective use of resources. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12609001022257 . Retrospectively registered on 25 November 2009

Abstract Background Implementation research may play an important role in reducing research waste by identifying strategies that support translation of evidence into practice. Implementation of healthcare interventions is influenced by multiple factors including the organisational context, implementation strategies and features of the intervention as perceived by people delivering and receiving the intervention. Recently, concepts relating to perceived features of interventions have been gaining traction in published literature, namely, acceptability, fidelity, feasibility, scalability and sustainability. These concepts may influence uptake of healthcare interventions, yet there seems to be little consensus about their nature and impact. The aim of this paper is to develop a testable conceptual framework of implementability of healthcare interventions that includes these five concepts. Methods A multifaceted approach was used to develop and refine a conceptual framework of implementability of healthcare interventions. An overview of reviews identified reviews published between January 2000 and March 2021 that focused on at least one of the five concepts in relation to a healthcare intervention. These findings informed the development of a preliminary framework of implementability of healthcare interventions which was presented to a panel of experts. A nominal group process was used to critique, refine and agree on a final framework. Results A total of 252 publications were included in the overview of reviews. Of these, 32% were found to be feasible, 4% reported sustainable changes in practice and 9% were scaled up to other populations and/or settings. The expert panel proposed that scalability and sustainability of a healthcare intervention are dependent on its acceptability, fidelity and feasibility. Furthermore, acceptability, fidelity and feasibility require re-evaluation over time and as the intervention is developed and then implemented in different settings or with different populations. The final agreed framework of implementability provides the basis for a chronological, iterative approach to planning for wide-scale, long-term implementation of healthcare interventions. Conclusions We recommend that researchers consider the factors acceptability, fidelity and feasibility (proposed to influence sustainability and scalability) during the preliminary phases of intervention development, evaluation and implementation, and iteratively check these factors in different settings and over time.

Abstract Background Prehabilitation services assist patients in preparing for surgery, yet access to these services are often limited by geographical factors. Enabling rural and regional patients to access specialist surgical prehabilitation support with the use of telehealth technology has the potential to overcome health inequities and improve post-operative outcomes. Aim To evaluate the current and likely future impact of a telehealth preoperative education package for patients preparing for major abdominal cancer surgery. Methods A telehealth alternative to a hospital based pre-operative education session was developed and implemented at a dedicated cancer hospital. Adult patients (≥18 years) scheduled for elective major cancer surgery were offered this telehealth alternative. Impact evaluation was conducted using the RE-AIM framework. Results To date, 35 participants have consented to participate in the study. Thirty-one participants attended the intervention; 24 (69%) residing in rural or regional areas. Twenty-four (77%) reported that if given a choice they would prefer the online session as opposed to attending the hospital in person. The majority (97%) reported they would recommend the intervention to others preparing for surgery. Session information was recalled by all 26 participants and 77% of participants reported acting on recommendations 2 weeks after the session. Lessons learnt and recommendations for providers implementing similar programs are reported. Conclusion Telehealth alternatives to hospital based pre-operative education are well received by patients preparing for major cancer surgery. We make seven recommendations to improve implementation. Further evaluation of implementation strategies alongside clinical effectiveness in future studies is essential. Trial registration ACTRN12620000096954 , 04/02/2020.

Abstract Background Decreasing ineffective or harmful healthcare practices (de-implementation) may require different approaches than those used to promote uptake of effective practices (implementation). Few psychological theories differentiate between processes involved in decreasing, versus increasing, behaviour. However, it is unknown whether implementation and de-implementation interventions already use different approaches. We used the behaviour change technique (BCT) taxonomy (version 1) (which includes 93 BCTs organised into 12 groupings) to investigate whether implementation and de-implementation interventions for clinician behaviour change use different BCTs. Methods Intervention descriptions in 181 articles from three systematic reviews in the Cochrane Library were coded for (a) implementation versus de-implementation and (b) intervention content (BCTs) using the BCT taxonomy (v1). BCT frequencies were calculated and compared using Pearson’s chi-squared (χ 2), Yates’ continuity correction and Fisher’s exact test, where appropriate. Identified BCTs were ranked according to frequency and rankings for de-implementation versus implementation interventions were compared and described. Results Twenty-nine and 25 BCTs were identified in implementation and de-implementation interventions respectively. Feedback on behaviour was identified more frequently in implementation than de-implementation (Χ 2 (2, n=178) = 15.693, p = .000057). Three BCTs were identified more frequently in de-implementation than implementation: Behaviour substitution (Χ 2 (2, n=178) = 14.561, p = .0001; Yates’ continuity correction); Monitoring of behaviour by others without feedback (Χ 2 (2, n=178) = 16.187, p = .000057; Yates’ continuity correction); and Restructuring social environment (p = .000273; Fisher’s 2-sided exact test). Conclusions There were some significant differences between BCTs reported in implementation and de-implementation interventions suggesting that researchers may have implicit theories about different BCTs required for de-implementation and implementation. These findings do not imply that the BCTs identified as targeting implementation or de-implementation are effective, rather simply that they were more frequently used. These findings require replication for a wider range of clinical behaviours. The continued accumulation of additional knowledge and evidence into whether implementation and de-implementation is different will serve to better inform researchers and, subsequently, improve methods for intervention design.

Abstract Background Designing implementation interventions to change the behaviour of healthcare providers and other professionals in the health system requires detailed specification of the behaviour(s) targeted for change to ensure alignment between intervention components and measured outcomes. Detailed behaviour specification can help to clarify evidence-practice gaps, clarify who needs to do what differently, identify modifiable barriers and enablers, design interventions to address these and ultimately provides an indicator of what to measure to evaluate an intervention’s effect on behaviour change. An existing behaviour specification framework proposes four domains (Target, Action, Context, Time; TACT), but insufficiently clarifies who is performing the behaviour (i.e. the Actor). Specifying the Actor is especially important in healthcare settings characterised by multiple behaviours performed by multiple different people. We propose and describe an extension and re-ordering of TACT to enhance its utility to implementation intervention designers, practitioners and trialists: the Action, Actor, Context, Target, Time (AACTT) framework. We aim to demonstrate its application across key steps of implementation research and to provide tools for its use in practice to clarify the behaviours of stakeholders across multiple levels of the healthcare system. Methods and results We used French et al.’s four-step implementation process model to describe the potential applications of the AACTT framework for (a) clarifying who needs to do what differently, (b) identifying barriers and enablers, (c) selecting fit-for-purpose intervention strategies and components and (d) evaluating implementation interventions. Conclusions Describing and detailing behaviour using the AACTT framework may help to enhance measurement of theoretical constructs, inform development of topic guides and questionnaires, enhance the design of implementation interventions and clarify outcome measurement for evaluating implementation interventions.

Background: Cervical screening uptake is declining in several countries. Primary care practitioners could play a greater role in maximising uptake, but better understanding is needed of practitioners’ cervical screening-related behaviours. Among general practitioners (GPs) and practice nurses, we aimed to identify cervical screening-related clinical behaviours; clarify practitioners’ roles/responsibilities; and determine factors likely to influence clinical behaviours. Methods: Telephone interviews were conducted with GPs and practice nurses in Ireland. Interview transcripts were analysed using the Theoretical Domains Framework (TDF), a comprehensive psychological framework of factors influencing clinical behaviour. Results: 14 GPs and 19 practice nurses participated. Key clinical behaviours identified were offering smears and encouraging women to attend for smears. Smeartaking responsibility was considered a predominantly female role. Of 12 possible theoretical domains, 11 were identified in relation to these behaviours. Those judged to be the most important were beliefs about capabilities; environmental context and resources; social influences; and behavioural regulation. Difficulties in obtaining smears from certain subgroups of women and inexperience of some GPs in smeartaking arose in relation to beliefs about capabilities. The need for public health education and reluctance of male practitioners to discuss cervical screening with female patients emerged in relation to social influences. Conclusions: We identified - for the first time - primary care practitioners’ cervical-screening related clinical behaviours, their perceived roles and responsibilities, and factors likely to influence behaviours. The results could inform initiatives to enable practitioners to encourage women to have smear tests which in turn, may help increase cervical screening uptake.

Abstract Background Providing health professionals with quantitative summaries of their clinical performance when treating specific groups of patients (“feedback”) is a widely used quality improvement strategy, yet systematic reviews show it has varying success. Theory could help explain what factors influence feedback success, and guide approaches to enhance effectiveness. However, existing theories lack comprehensiveness and specificity to health care. To address this problem, we conducted the first systematic review and synthesis of qualitative evaluations of feedback interventions, using findings to develop a comprehensive new health care-specific feedback theory. Methods We searched MEDLINE, EMBASE, CINAHL, Web of Science, and Google Scholar from inception until 2016 inclusive. Data were synthesised by coding individual papers, building on pre-existing theories to formulate hypotheses, iteratively testing and improving hypotheses, assessing confidence in hypotheses using the GRADE-CERQual method, and summarising high-confidence hypotheses into a set of propositions. Results We synthesised 65 papers evaluating 73 feedback interventions from countries spanning five continents. From our synthesis we developed Clinical Performance Feedback Intervention Theory (CP-FIT), which builds on 30 pre-existing theories and has 42 high-confidence hypotheses. CP-FIT states that effective feedback works in a cycle of sequential processes; it becomes less effective if any individual process fails, thus halting progress round the cycle. Feedback’s success is influenced by several factors operating via a set of common explanatory mechanisms: the feedback method used, health professional receiving feedback, and context in which feedback takes place. CP-FIT summarises these effects in three propositions: (1) health care professionals and organisations have a finite capacity to engage with feedback, (2) these parties have strong beliefs regarding how patient care should be provided that influence their interactions with feedback, and (3) feedback that directly supports clinical behaviours is most effective. Conclusions This is the first qualitative meta-synthesis of feedback interventions, and the first comprehensive theory of feedback designed specifically for health care. Our findings contribute new knowledge about how feedback works and factors that influence its effectiveness. Internationally, practitioners, researchers, and policy-makers can use CP-FIT to design, implement, and evaluate feedback. Doing so could improve care for large numbers of patients, reduce opportunity costs, and improve returns on financial investments. Trial registration PROSPERO, CRD42015017541

Abstract Background Evidence-based guidelines for management of mild traumatic brain injury (mTBI) in the emergency department (ED) are now widely available; however, clinical practice remains inconsistent with these guidelines. A targeted, theory-informed implementation intervention (Neurotrauma Evidence Translation (NET) intervention) was designed to increase the uptake of three clinical practice recommendations regarding the management of patients who present to Australian EDs with mild head injuries. The intervention involved local stakeholder meetings, identification and training of nursing and medical local opinion leaders, train-the-trainer workshops and standardised education materials and interactive workshops delivered by the opinion leaders to others within their EDs during a 3 month period. This paper reports on the effects of this intervention. Methods EDs (clusters) were allocated to receive either access to a clinical practice guideline (control) or the implementation intervention, using minimisation, a method that allocates clusters to groups using an algorithm to minimise differences in predefined factors between the groups. We measured clinical practice outcomes at the patient level using chart audit. The primary outcome was appropriate screening for post-traumatic amnesia (PTA) using a validated tool until a perfect score was achieved (indicating absence of acute cognitive impairment) before the patient was discharged home. Secondary outcomes included appropriate CT scanning and the provision of written patient information upon discharge. Patient health outcomes (anxiety, primary outcome: Hospital Anxiety and Depression Scale) were also assessed using follow-up telephone interviews. Outcomes were assessed by independent auditors and interviewers, blinded to group allocation. Results Fourteen EDs were allocated to the intervention and 17 to the control condition; 1943 patients were included in the chart audit. At 2 months follow-up, patients attending intervention EDs (n = 893) compared with control EDs (n = 1050) were more likely to have been appropriately assessed for PTA (adjusted odds ratio (OR) 20.1, 95%CI 6.8 to 59.3; adjusted absolute risk difference (ARD) 14%, 95%CI 8 to 19). The odds of compliance with recommendations for CT scanning and provision of written patient discharge information were small (OR 1.2, 95%CI 0.8 to 1.6; ARD 3.2, 95%CI − 3.7 to 10 and OR 1.2, 95%CI 0.8 to 1.8; ARD 3.1, 95%CI − 3.0 to 9.3 respectively). A total of 343 patients at ten interventions and 14 control sites participated in follow-up interviews at 4.3 to 10.7 months post-ED presentation. The intervention had a small effect on anxiety levels (adjusted mean difference − 0.52, 95%CI − 1.34 to 0.30; scale 0–21, with higher scores indicating greater anxiety). Conclusions Our intervention was effective in improving the uptake of the PTA recommendation; however, it did not appreciably increase the uptake of the other two practice recommendations. Improved screening for PTA may be clinically important as it leads to appropriate periods of observation prior to safe discharge. The estimated intervention effect on anxiety was of limited clinical significance. We were not able to compare characteristics of EDs who declined trial participation with those of participating sites, which may limit the generalizability of the results. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12612001286831), date registered 12 December 2012.

Abstract Background Implementing evidence-based care requires healthcare practitioners to do less of some things (de-implementation) and more of others (implementation). Variations in effectiveness of behaviour change interventions may result from failure to consider a distinction between approaches by which behaviour increases and decreases in frequency. The distinction is not well represented in methods for designing interventions. This review aimed to identify whether there is a theoretical rationale to support this distinction. Methods Using Critical Interpretative Synthesis, this conceptual review included papers from a broad range of fields (biology, psychology, education, business) likely to report approaches for increasing or decreasing behaviour. Articles were identified from databases using search terms related to theory and behaviour change. Articles reporting changes in frequency of behaviour and explicit use of theory were included. Data extracted were direction of behaviour change, how theory was operationalised, and theory-based recommendations for behaviour change. Analyses of extracted data were conducted iteratively and involved inductive coding and critical exploration of ideas and purposive sampling of additional papers to explore theoretical concepts in greater detail. Results Critical analysis of 66 papers and their theoretical sources identified three key findings: (1) 9 of the 15 behavioural theories identified do not distinguish between implementation and de-implementation (5 theories were applied to only implementation or de-implementation, not both); (2) a common strategy for decreasing frequency was substituting one behaviour with another. No theoretical basis for this strategy was articulated, nor were methods proposed for selecting appropriate substitute behaviours; (3) Operant Learning Theory makes an explicit distinction between techniques for increasing and decreasing frequency. Discussion Behavioural theories provide little insight into the distinction between implementation and de-implementation. Operant Learning Theory identified different strategies for implementation and de-implementation, but these strategies may not be acceptable in health systems. Additionally, if behaviour substitution is an approach for de-implementation, further investigation may inform methods or rationale for selecting the substitute behaviour.

Objectives: To identify perceived influences on implementation of antibiotic stewardship programmes (ASPs) in hospitals, across healthcare systems, and to exemplify the use of a behavioral framework to conceptualize those influences.Methods: EMBASE and MEDLINE databases were searched from 01/2001 to 07/2017 and reference lists were screened for transnational studies that reported barriers and/or facilitators to implementing actual or hypothetical ASPs or ASP-supporting strategies. Extracted data were synthesized using content analysis with the Theoretical Domains Framework as an organizing framework. Commonly reported influences were quantified.Results: From 3,196 abstracts 75 full-text articles were screened for inclusion. Eight studies met the eligibility criteria. The number of countries involved in each study ranged from 2 to 36. These studies included a total of 1849 participants. North America, Europe and Australasia had the strongest representation. Participants were members of special interest groups, designated hospital representatives or clinical experts. Ten of the 14 theoretical domains in the framework were present in the results reported in the included studies. The most commonly reported (≥4 out of 8 studies) influences on ASP implementation were coded in the domain “environmental context and resources” (e.g., problems with data and information systems; lack of key personnel; inadequate financial resources) and “goals” (other higher priorities).Conclusions: Despite an extensive transnational research effort, there is evidence from international studies of substantial barriers to implementing ASPs in hospitals, even in developed countries. Large-scale efforts to implement hospital antibiotic stewardship in those countries will need to overcome issues around inadequacy of information systems, unavailability of key personnel and funding, and the competition from other priority initiatives. We have enhanced the evidence base to inform guidance by taking a behavioral approach to identify influences on ASP uptake.Systematic review registration: PROSPERO registration number CRD42017076425.

Abstract Background National diabetes audits in the UK show room for improvement in the quality of care delivered to people with type 2 diabetes in primary care. Systematic reviews of quality improvement interventions show that such approaches can be effective but there is wide variability between trials and little understanding concerning what explains this variability. A national cohort study of primary care across 99 UK practices identified modifiable predictors of healthcare professionals’ prescribing, advising and foot examination. Our objective was to evaluate the effectiveness of an implementation intervention to improve six guideline-recommended health professional behaviours in managing type 2 diabetes in primary care: prescribing for blood pressure and glycaemic control, providing physical activity and nutrition advice and providing updated diabetes education and foot examination. Methods Two-armed cluster randomised trial involving 44 general practices. Primary outcomes (at 12 months follow-up): from electronic medical records, the proportion of patients receiving additional prescriptions for blood pressure and insulin initiation for glycaemic control and having a foot examination; and from a patient survey of a random sample of 100 patients per practice, reported receipt of updated diabetes education and physical activity and nutrition advice. Results The implementation intervention did not lead to statistically significant improvement on any of the six clinical behaviours. 1,138,105 prescriptions were assessed. Intervention (29% to 37% patients) and control arms (31% to 35%) increased insulin initiation relative to baseline but were not statistically significantly different at follow-up (IRR 1.18, 95%CI 0.95–1.48). Intervention (45% to 53%) and control practices (45% to 50%) increased blood pressure prescription from baseline to follow-up but were not statistically significantly different at follow-up (IRR 1.05, 95%CI 0.96 to 1.16). Intervention (75 to 78%) and control practices (74 to 79%) increased foot examination relative to baseline; control practices increased statistically significantly more (OR 0.84, 95%CI 0.75–0.94). Fewer patients in intervention (33%) than control practices (40%) reported receiving updated diabetes education (OR = 0.74, 95%CI 0.57–0.97). No statistically significant differences were observed in patient reports of having had a discussion about nutrition (intervention = 73%; control = 72%; OR = 0.98, 95%CI 0.59–1.64) or physical activity (intervention = 57%; control = 62%; OR = 0.79, 95%CI 0.56–1.11). Development and delivery of the intervention cost £1191 per practice. Conclusions There was no measurable benefit to practices’ participation in this intervention. Despite widespread use of outreach interventions worldwide, there is a need to better understand which techniques at which intensity are optimally suited to address the multiple clinical behaviours involved in improving care for type 2 diabetes. Trial registration ISRCTN, ISRCTN66498413. Registered April 4, 2013

Abstract Background Non-retention of participants seriously affects the credibility of clinical trial results and significantly reduces the potential of a trial to influence clinical practice. Non-retention can be defined as instances where participants leave the study prematurely. Examples include withdrawal of consent and loss to follow-up and thus outcome data cannot be obtained. The majority of existing interventions targeting retention fail to describe any theoretical basis for the observed improvement, or lack of improvement. Moreover, most of these interventions lack involvement of participants in their conception and/or design, raising questions about their relevance and acceptability. Many of the causes of non-retention involve people performing a behaviour (e.g. not returning a questionnaire). Behaviour change is difficult, and the importance of a strong theoretical basis for interventions that aim to change behaviour is increasingly recognised. This research aims to develop and pilot theoretically informed, participant-centred, evidence-based behaviour change interventions to improve retention in trials. Methods This research will generate data through semi-structured interviews on stakeholders’ perspectives of the reasons for trial non-retention. It will identify perceived barriers and enablers to trial retention using the Theoretical Domains Framework. The intervention development work will involve identification of behaviour change techniques, using recognised methodology, and co-production of retention interventions through discussion groups with end-users. An evaluation of intervention acceptability and feasibility will be conducted in focus groups. Finally, a ready-to-use evaluation framework to deploy in Studies Within A Trial as well as an explanatory retention framework will be developed for identifying and tackling modifiable issues to improve trial retention. Discussion We believe this to be one of the first studies to apply a theoretical lens to the development of interventions to improve trial retention that have been informed by, and are embedded within, participants’ experiential accounts. By developing and identifying priority interventions this study will support efforts to reduce research waste.

Abstract Background Audit and feedback aims to guide health professionals in improving aspects of their practice that need it most. Evidence suggests that feedback fails to increase accuracy of professional perceptions about clinical performance, which likely reduces audit and feedback effectiveness. This study investigates health professionals’ perceptions about their clinical performance and the influence of feedback on their intentions to change practice. Methods We conducted an online laboratory experiment guided by Control Theory with 72 intensive care professionals from 21 units. For each of four new pain management indicators, we collected professionals’ perceptions about their clinical performance; peer performance; targets; and improvement intentions before and after receiving first-time feedback. An electronic audit and feedback dashboard provided ICU’s own performance, median and top 10% peer performance, and improvement recommendations. The experiment took place approximately 1 month before units enrolled into a cluster-randomised trial assessing the impact of adding a toolbox with suggested actions and materials to improve intensive care pain management. During the experiment, the toolbox was inaccessible; all participants accessed the same version of the dashboard. Results We analysed 288 observations. In 53.8%, intensive care professionals overestimated their clinical performance; but in only 13.5%, they underestimated it. On average, performance was overestimated by 22.9% (on a 0–100% scale). Professionals similarly overestimated peer performance, and set targets 20.3% higher than the top performance benchmarks. In 68.4% of cases, intentions to improve practice were consistent with actual gaps in performance, even before professionals had received feedback; which increased to 79.9% after receiving feedback (odds ratio, 2.41; 95% CI, 1.53 to 3.78). However, in 56.3% of cases, professionals still wanted to improve care aspects at which they were already top performers. Alternatively, in 8.3% of cases, they lacked improvement intentions because they did not consider indicators important; did not trust the data; or deemed benchmarks unrealistic. Conclusions Audit and feedback helps health professionals to work on aspects for which improvement is recommended. Given the abundance of professionals’ prior good improvement intentions, the limited effects typically found by audit and feedback studies are likely predominantly caused by barriers to translation of intentions into actual change in clinical practice. Trial registration ClinicalTrials.gov NCT02922101. Registered 26 September 2016.

Abstract Background Despite a supportive evidence base and a push to implement, the uptake of early rehabilitation in critical care has been inconsistent. The objective of this study was to explore barriers and facilitators to early rehabilitation for critically ill patients receiving invasive mechanical ventilation. Methods Using the Theoretical Domains Framework (TDF) of behavior change, we conducted semi-structured interviews exploring barriers and facilitators to early rehabilitation among four purposively sampled ICU clinician groups (nurses, rehabilitation professionals, respiratory therapists, and physicians). The TDF is a comprehensive framework of 14 “construct domains,” synthesized from 33 theories of behavior that was developed to study determinants of behavior and to design interventions to improve evidence-based healthcare practice. A topic guide was developed and piloted based on the TDF and expert knowledge. Interviews were audio-recorded and transcribed verbatim. Transcripts were content analyzed by coding items into domains and then synthesized into more specific, over-arching themes or “beliefs.” An expert consensus group used structured decision rules to classify beliefs as high, moderate, or low in importance. Results We interviewed 40 stakeholders from the four clinician groups and identified 135 separate beliefs. Of these, 19 were classified as high, 40 as moderate, and 76 of low importance as barriers or facilitators. All beliefs classified as highly important fell within one of seven TDF domains: skills, social/professional role and identity, beliefs about capabilities, beliefs about consequences, environmental context/resources, social influences, and behavioral regulation. Beliefs of lower importance fell under the following seven domains: knowledge; optimism; reinforcement; intention; goals; memory, attention, and decision processes; and emotion. Quantitative differences in stated beliefs about early rehabilitation between professional groups were not common. Conclusions This study identified important barriers and facilitators to early rehabilitation in critical care patients. Domains identified as important should be considered when designing interventions to increase uptake of early rehabilitation.

Abstract Background Intermittent Auscultation (IA) is the recommended method of fetal surveillance for healthy women in labour. However, the majority of women receive continuous electronic monitoring. We used the Theoretical Domains Framework (TDF) to explore the views of Birthing Unit nurses about using IA as their primary method of fetal surveillance for healthy women in labour. Methods Using a semi-structured interview guide, we interviewed a convenience sample of birthing unit nurses throughout Ontario, Canada to elicit their views about fetal surveillance. Interviews were recorded and transcribed verbatim. Transcripts were content analysed using the TDF and themes were framed as belief statements. Domains potentially key to changing fetal surveillance behaviour and informing intervention design were identified by noting the frequencies of beliefs, content, and their reported influence on the use of IA. Results We interviewed 12 birthing unit nurses. Seven of the 12 TDF domains were perceived to be key to changing birthing unit nurses’ behaviour The nurses reported that competing tasks, time constraints and the necessity to multitask often limit their ability to perform IA (domains Beliefs about capabilities; Environmental context and resources). Some nurses noted the decision to use IA was something that they consciously thought about with every patient while others stated it their default decision as long as there were no risk factors (Memory, attention and decision processes, Nature of behaviour). They identified positive consequences (e.g. avoid unnecessary interventions, mother-centered care) and negative consequences of using IA (e.g. legal concerns) and reported that the negative consequences can often outweigh positive consequences (Beliefs about consequences). Some reported that hospital policies and varying support from care teams inhibited their use of IA (Social influences), and that support from the entire team and hospital management would likely increase their use (Social influences; Behavioural regulation). Conclusion We identified potential influences on birthing unit nurses’ use of IA as their primary method of fetal surveillance. These beliefs suggest potential targets for behaviour change interventions to promote IA use.

Abstract Background Blood for transfusion is a frequently used clinical intervention, and is also a costly and limited resource with risks. Many transfusions are given to stable and non-bleeding patients despite no clear evidence of benefit from clinical studies. Audit and feedback (A&F) is widely used to improve the quality of healthcare, including appropriate use of blood. However, its effects are often inconsistent, indicating the need for coordinated research including more head-to-head trials comparing different ways of delivering feedback. A programmatic series of research projects, termed the ‘Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE’ (AFFINITIE) programme, aims to test different ways of developing and delivering feedback within an existing national audit structure. Methods The evaluation will comprise two linked 2×2 factorial, cross-sectional cluster-randomised controlled trials. Each trial will estimate the effects of two feedback interventions, ‘enhanced content’ and ‘enhanced follow-on support’, designed in earlier stages of the AFFINITIE programme, compared to current practice. The interventions will be embedded within two rounds of the UK National Comparative Audit of Blood Transfusion (NCABT) focusing on patient blood management in surgery and use of blood transfusions in patients with haematological malignancies. The unit of randomisation will be National Health Service (NHS) trust or health board. Clusters providing care relevant to the audit topics will be randomised following each baseline audit (separately for each trial), with stratification for size (volume of blood transfusions) and region (Regional Transfusion Committee). The primary outcome for each topic will be the proportion of patients receiving a transfusion coded as unnecessary. For each audit topic a linked, mixed-method fidelity assessment and cost-effectiveness analysis will be conducted in parallel to the trial. Discussion AFFINITIE involves a series of studies to explore how A&F may be refined to change practice including two cluster randomised trials linked to national audits of transfusion practice. The methodology represents a step-wise increment in study design to more fully evaluate the effects of two enhanced feedback interventions on patient- and trust-level clinical, cost, safety and process outcomes. Trial registration http://www.isrctn.com/ISRCTN15490813

Abstract Background A general practitioner (GP)-targeted intervention aimed at improving the prescribing of appropriate polypharmacy for older people was previously developed using a systematic, theory-based approach based on the UK Medical Research Council’s complex intervention framework. The primary intervention component comprised a video demonstration of a GP prescribing appropriate polypharmacy during a consultation with an older patient. The video was delivered to GPs online and included feedback emphasising the positive outcomes of performing the behaviour. As a complementary intervention component, patients were invited to scheduled medication review consultations with GPs. This study aimed to test the feasibility of the intervention and study procedures (recruitment, data collection). Methods GPs from two general practices were given access to the video, and reception staff scheduled consultations with older patients receiving polypharmacy (≥4 medicines). Primary feasibility study outcomes were the usability and acceptability of the intervention to GPs. Feedback was collected from GP and patient participants using structured questionnaires. Clinical data were also extracted from recruited patients’ medical records (baseline and 1 month post-consultation). The feasibility of applying validated assessment of prescribing appropriateness (STOPP/START criteria, Medication Appropriateness Index) and medication regimen complexity (Medication Regimen Complexity Index) to these data was investigated. Data analysis was descriptive, providing an overview of participants’ feedback and clinical assessment findings. Results Four GPs and ten patients were recruited across two practices. The intervention was considered usable and acceptable by GPs. Some reservations were expressed by GPs as to whether the video truly reflected resource and time pressures encountered in the general practice working environment. Patient feedback on the scheduled consultations was positive. Patients welcomed the opportunity to have their medications reviewed. Due to the short time to follow-up and a lack of detailed clinical information in patient records, it was not feasible to detect any prescribing changes or to apply the assessment tools to patients’ clinical data. Conclusion The findings will help to further refine the intervention and study procedures (including time to follow-up) which will be tested in a randomised pilot study that will inform the design of a definitive trial to evaluate the intervention’s effectiveness. Trial registration ISRCTN18176245

Abstract Background It is advocated that interventions to improve clinical practice should be developed using a systematic approach and intervention development methods should be reported. However, previous interventions aimed at ensuring that older people receive appropriate polypharmacy have lacked details on their development. This study formed part of a multiphase research project which aimed to develop an intervention to improve appropriate polypharmacy in older people in primary care. Methods The target behaviours for the intervention were prescribing and dispensing of appropriate polypharmacy to older patients by general practitioners (GPs) and community pharmacists. Intervention development followed a systematic approach, including previous mapping of behaviour change techniques (BCTs) to key domains from the Theoretical Domains Framework that were perceived by GPs and pharmacists to influence the target behaviours. Draft interventions were developed to operationalise selected BCTs through team discussion. Selection of an intervention for feasibility testing was guided by a subset of the APEASE (Affordability, Practicability, Effectiveness/cost-effectiveness, Acceptability, Side-effects/safety, Equity) criteria. Results Three draft interventions comprising selected BCTs were developed, targeting patients, pharmacists and GPs, respectively. Following assessment of each intervention using a subset of the APEASE criteria (affordability, practicability, acceptability), the GP-targeted intervention was selected for feasibility testing. This intervention will involve a demonstration of the behaviour and will be delivered as an online video. The video demonstrating how GPs can prescribe appropriate polypharmacy during a typical consultation with an older patient will also demonstrate salience of consequences (feedback emphasising the positive outcomes of performing the behaviour). Action plans and prompts/cues will be used as complementary intervention components. The intervention is designed to facilitate the prescribing of appropriate polypharmacy in routine practice. Conclusion A GP-targeted intervention to improve appropriate polypharmacy in older people has been developed using a systematic approach. Intervention content has been specified using an established taxonomy of BCTs and selected to maximise feasibility. The results of a future feasibility study will help to determine if the theory-based intervention requires further refinement before progressing to a larger scale randomised evaluation.

Objective The ‘To Dip or Not to Dip’ (TDONTD) intervention aims to reduce antibiotic prescribing for urinary tract infection (UTI) by reducing low-value dipstick testing. The aims of this study were to use a qualitative approach to (1) evaluate potential influences on the delivery of the TDONTD intervention in Australian residential aged care homes (RACHs) by identifying perceived barriers and enablers to delivery and acceptance; and (2) propose intervention strategies to address barriers and enhance enablers.Design A qualitative before–after process evaluation of a multisite implementation study using interviews with nurse and pharmacist implementers.Setting This study was conducted in 12 Australian RACHs.Participants Participants included 17 on-site nurse champions and 4 pharmacists (existing contracted providers).Intervention Resources from England’s TDONTD intervention were adapted for an Australian context. Key resources delivered were case-based education, staff training video, clinical pathway and an audit tool.Results Key barriers to TDONTD were beliefs about nursing capabilities in diagnosing infection, beliefs about consequences (fear of missing infection) and social influences (pressure from family, doctors and hospitals). Key enablers were perceived increased nurse and carer knowledge (around UTI and asymptomatic bacteriuria), resources from a credible source, empowerment of nurse champions to apply knowledge and skills in delivering operational change initiatives, pharmacist-delivered education and organisational policy or process change. Of TDONTD’s key components, the clinical pathway substituted dipstick testing in diagnosing UTI, delivery of case-based education was enhanced by their attendance and support of the intervention and the antibiotic audit tool generated feedback that champions shared with staff.Conclusions Our study confirms the core components of TDONTD and strategies to enhance delivery and overcome barriers. To further reduce barriers to TDONTD, broader advocacy work is required to raise awareness of dipstick testing as a low-value test in older persons and by linking it to healthcare professionals and consumer education.