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Redesigning the ‘choice architecture’ of hospital prescription charts: a mixed methods study incorporating in situ simulation testing

D King, A Jabbar, E Charani

BMJ Open 2014

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Objectives To incorporate behavioural insights into the user-centred design of an inpatient prescription chart (Imperial Drug Chart Evaluation and Adoption Study, IDEAS chart) and to determine whether changes in the content and design of prescription charts could influence prescribing behaviour and reduce prescribing errors. Design A mixed-methods approach was taken in the development phase of the project; in situ simulation was used to evaluate the effectiveness of the newly developed IDEAS prescription chart. Setting A London teaching hospital. Interventions/methods A multimodal approach comprising (1) an exploratory phase consisting of chart reviews, focus groups and user insight gathering (2) the iterative design of the IDEAS prescription chart and finally (3) testing of final chart with prescribers using in situ simulation. Results Substantial variation was seen between existing inpatient prescription charts used across 15 different UK hospitals. Review of 40 completed prescription charts from one hospital demonstrated a number of frequent prescribing errors including illegibility, and difficulty in identifying prescribers. Insights from focus groups and direct observations were translated into the design of IDEAS chart. In situ simulation testing revealed significant improvements in prescribing on the IDEAS chart compared with the prescription chart currently in use in the study hospital. Medication orders on the IDEAS chart were significantly more likely to include correct dose entries (164/164 vs 166/174; p=0.0046) as well as prescriber's printed name (163/164 vs 0/174; p<0.0001) and contact number (137/164 vs 55/174; p<0.0001). Antiinfective indication (28/28 vs 17/29; p<0.0001) and duration (26/28 vs 15/29; p<0.0001) were more likely to be completed using the IDEAS chart. Conclusions In a simulated context, the IDEAS prescription chart significantly reduced a number of common prescribing errors including dosing errors and illegibility. Positive behavioural change was seen without prior education or support, suggesting that some common prescription writing errors are potentially rectifiable simply through changes in the content and design of prescription charts.

 


Provision of social norm feedback to high prescribers of antibiotics in general practice: a pragmatic national randomised controlled trial.

Michael Hallsworth, Tim Chadborn, Anna Sallis, Michael Sanders, Daniel Berry, Felix Greaves, Lara Clements, Sally Davies

Lancet (London, England) [387:1743-52] (2016)

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Unnecessary antibiotic prescribing contributes to antimicrobial resistance. In this trial, we aimed to reduce unnecessary prescriptions of antibiotics by general practitioners (GPs) in England. In this randomised, 2 × 2 factorial trial, publicly available databases were used to identify GP practices whose prescribing rate for antibiotics was in the top 20% for their National Health Service (NHS) Local Area Team. Eligible practices were randomly assigned (1:1) into two groups by computer-generated allocation sequence, stratified by NHS Local Area Team. Participants, but not investigators, were blinded to group assignment. On Sept 29, 2014, every GP in the feedback intervention group was sent a letter from England's Chief Medical Officer and a leaflet on antibiotics for use with patients. The letter stated that the practice was prescribing antibiotics at a higher rate than 80% of practices in its NHS Local Area Team. GPs in the control group received no communication. The sample was re-randomised into two groups, and in December, 2014, GP practices were either sent patient-focused information that promoted reduced use of antibiotics or received no communication. The primary outcome measure was the rate of antibiotic items dispensed per 1000 weighted population, controlling for past prescribing. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN32349954, and has been completed. Between Sept 8 and Sept 26, 2014, we recruited and assigned 1581 GP practices to feedback intervention (n=791) or control (n=790) groups. Letters were sent to 3227 GPs in the intervention group. Between October, 2014, and March, 2015, the rate of antibiotic items dispensed per 1000 population was 126.98 (95% CI 125.68-128.27) in the feedback intervention group and 131.25 (130.33-132.16) in the control group, a difference of 4.27 (3.3%; incidence rate ratio [IRR] 0.967 [95% CI 0.957-0.977]; p<0.0001), representing an estimated 73,406 fewer antibiotic items dispensed. In December, 2014, GP practices were re-assigned to patient-focused intervention (n=777) or control (n=804) groups. The patient-focused intervention did not significantly affect the primary outcome measure between December, 2014, and March, 2015 (antibiotic items dispensed per 1000 population: 135.00 [95% CI 133.77-136.22] in the patient-focused intervention group and 133.98 [133.06-134.90] in the control group; IRR for difference between groups 1.01, 95% CI 1.00-1.02; p=0.105). Social norm feedback from a high-profile messenger can substantially reduce antibiotic prescribing at low cost and at national scale; this outcome makes it a worthwhile addition to antimicrobial stewardship programmes. Public Health England.

 


Development of a Theory-Based Intervention to Increase Clinical Measurement of Reactive Balance in Adults at Risk of Falls.

Kathryn Sibley, Dina Brooks, Paula Gardner, Tania Janaudis-Ferreira, Mandy McGlynn, Sachi OʼHoski, Sara McEwen, Nancy Salbach, Jennifer Shaffer, Paula Shing, Sharon Straus, Susan Jaglal

Journal of neurologic physical therapy : JNPT [40:100-6] (2016)

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Effective balance reactions are essential for avoiding falls, but are not regularly measured by physical therapists. Physical therapists report wanting to improve reactive balance assessment, and theory-based approaches are recommended as the foundation for the development of interventions. This article describes how a behavior change theory for health care providers, the theoretical domains framework (TDF), was used to develop an intervention to increase reactive balance measurement among physical therapists who work in rehabilitation settings and treat adults who are at risk of falls. We employed published recommendations for using the TDF-guided intervention development. We identified what health care provider behavior is in need of change, relevant barriers and facilitators, strategies to address them, and how we would measure behavior change. In this case, identifying strategies required selecting both a reactive balance measure and behavior change techniques. Previous research had determined that physical therapists need to increase reactive balance measurement, and identified barriers and facilitators that corresponded to 8 TDF domains. A published review informed the selection of the Balance Evaluation Systems Test (Reactive Postural Responses Section) as addressing the barriers and facilitators, and existing research informed the selection of 9 established behavior change techniques corresponding to each identified TDF domain. The TDF framework were incorporated into a 12-month intervention with interactive group sessions, local champions, and health record modifications. Intervention effect can be evaluated using health record abstraction, questionnaires, and qualitative semistructured interviews. Although future research will evaluate the intervention in a controlled study, the process of theory-based intervention development can be applied to other rehabilitation research contexts, maximizing the impact of this work.Video Abstract is available for more insights from the authors (see Supplemental Digital Content 1, http://links.lww.com/JNPT/A123).

 


Characterising an implementation intervention in terms of behaviour change techniques and theory: the 'Sepsis Six' clinical care bundle.

Siri Steinmo, Christopher Fuller, Sheldon Stone, Susan Michie

Implementation science : IS [10:111] (2015)

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Sepsis is a major cause of death from infection, with a mortality rate of 36 %. This can be halved by implementing the 'Sepsis Six' evidence-based care bundle within 1 h of presentation. A UK audit has shown that median implementation rates are 27-47 % and interventions to improve this have demonstrated minimal effects. In order to develop more effective implementation interventions, it is helpful to obtain detailed characterisations of current interventions and to draw on behavioural theory to identify mechanisms of change. The aim of this study was to illustrate this process by using the Behaviour Change Wheel; Behaviour Change Technique (BCT) Taxonomy; Capability, Opportunity, Motivation model of behaviour; and Theoretical Domains Framework to characterise the content and theoretical mechanisms of action of an existing intervention to implement Sepsis Six. Data came from documentary, interview and observational analyses of intervention delivery in several wards of a UK hospital. A broad description of the intervention was created using the Template for Intervention Description and Replication framework. Content was specified in terms of (i) component BCTs using the BCT Taxonomy and (ii) intervention functions using the Behaviour Change Wheel. Mechanisms of action were specified using the Capability, Opportunity, Motivation model and the Theoretical Domains Framework. The intervention consisted of 19 BCTs, with eight identified using all three data sources. The BCTs were delivered via seven functions of the Behaviour Change Wheel, with four ('education', 'enablement', 'training' and 'environmental restructuring') supported by the three data sources. The most frequent mechanisms of action were reflective motivation (especially 'beliefs about consequences' and 'beliefs about capabilities') and psychological capability (especially 'knowledge'). The intervention consisted of a wide range of BCTs targeting a wide range of mechanisms of action. This study demonstrates the utility of the Behaviour Change Wheel, the BCT Taxonomy and the Theoretical Domains Framework, tools recognised for providing guidance for intervention design, for characterising an existing intervention to implement evidence-based care.

 


Strengthening the role and functions of nursing staff in inpatient stroke rehabilitation: developing a complex intervention using the Behaviour Change Wheel.

Mia Ingerslev Loft, Bente Martinsen, Bente Appel Esbensen, Lone Mathiesen, Helle Iversen, Ingrid Poulsen

International journal of qualitative studies on health and well-being [12:1392218] (2017)

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Over the past two decades, attempts have been made to describe the nurse's role and functions in the inpatient stroke rehabilitation; however, the nursing contribution is neither clear nor well-defined. Previous studies have highlighted the need for research aimed at developing interventions in the neuro-nursing area. The objective of this paper was to describe the development of a nursing intervention aimed at optimising the inpatient rehabilitation of stroke patients by strengthening the role and functions of nursing staff. A systematic approach was used, consistent with the framework for developing and evaluating complex interventions by the UK's Medical Research Council (MRC). Based on qualitative methods and using the Behaviour Change Wheel's (BCW) stepwise approach, we sought behaviours related to nursing staffs' roles and functions. We conducted a behavioural analysis to explain why nursing staff were or were not engaged in these behaviours. The nursing staff's Capability, Opportunity and Motivation were analysed with regard to working systematically with a rehabilitative approach and working deliberately and systematically with the patient's goals. We developed the educational intervention Rehabilitation 24/7. Following the MRC and the BCW frameworks is resource-consuming, but offers a way of developing a practical, well-structured intervention that is theory- and evidence based.

 


Evaluation of a tailored, multi-component intervention for implementation of evidence-based clinical practice guidelines in primary care physical therapy: a non-randomized controlled trial.

Susanne Bernhardsson, Maria EH Larsson, Robert Eggertsen, Monika Fagevik Olsén, Kajsa Johansson, Per Nilsen, Lena Nordeman, Maurits van Tulder, Birgitta Öberg

BMC health services research [14:105] (2014)

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Clinical practice guidelines are important for transmitting research findings into practice and facilitating the application of evidence-based practice (EBP). There is a paucity of knowledge about the impact of guideline implementation strategies in primary care physical therapy. The aim of this study was to evaluate the effect of a guideline implementation intervention in primary care physical therapy in western Sweden. An implementation strategy based on theory and current evidence was developed. A tailored, multi-component implementation intervention, addressing earlier identified determinants, was carried out in three areas comprising 28 physical therapy practices including 277 physical therapists (PTs) (intervention group). In two adjacent areas, 171 PTs at 32 practices received no intervention (control group). The core component of the intervention was an implementation seminar with group discussions. Among other components were a website and email reminders. Data were collected at baseline and follow-up with a web-based questionnaire. Primary outcomes were the self-reported awareness of, knowledge of, access to, and use of guidelines. Secondary outcomes were self-reported attitudes toward EBP and guidelines. Analyses were performed using Pearson's χ2 test and approximative z-test. 168 PTs (60.6%) in the intervention group and 88 PTs (51.5%) in the control group responded to the follow-up questionnaire. 186/277 PTs (67.1%) participated in the implementation seminars, of which 97 (52.2%) responded. The proportions of PTs reporting awareness of (absolute difference in change 20.6%, p = 0.023), knowledge where to find (20.4%, p = 0.007), access to (21.7%, p < 0.001), and frequent use of (9.5%, NS) guidelines increased more in the intervention group than in the control group. The proportion of PTs reporting frequent guideline use after participation in the implementation seminar was 15.2% (p = 0.043) higher than the proportion in the control group. A higher proportion considered EBP helpful in decision making (p = 0.018). There were no other significant differences in secondary outcomes. A tailored, theory- and evidence-informed, multi-component intervention for the implementation of clinical practice guidelines had a modest, positive effect on awareness of, knowledge of, access to, and use of guidelines, among PTs in primary care in western Sweden. In general, attitudes to EBP and guidelines were not affected.

 


The demonstration of a theory-based approach to the design of localized patient safety interventions.

Natalie Taylor, Rebecca Lawton, Beverley Slater, Robbie Foy

Implementation science : IS [8:123] (2013)

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There is evidence of unsafe care in healthcare systems globally. Interventions to implement recommended practice often have modest and variable effects. Ideally, selecting and adapting interventions according to local contexts should enhance effects. However, the means by which this can happen is seldom systematic, based on theory, or made transparent. This work aimed to demonstrate the applicability, feasibility, and acceptability of a theoretical domains framework implementation (TDFI) approach for co-designing patient safety interventions. We worked with three hospitals to support the implementation of evidence-based guidance to reduce the risk of feeding into misplaced nasogastric feeding tubes. Our stepped process, informed by the TDF and key principles from implementation literature, entailed: involving stakeholders; identifying target behaviors; identifying local factors (barriers and levers) affecting behavior change using a TDF-based questionnaire; working with stakeholders to generate specific local strategies to address key barriers; and supporting stakeholders to implement strategies. Exit interviews and audit data collection were undertaken to assess the feasibility and acceptability of this approach. Following audit and discussion, implementation teams for each Trust identified the process of checking the positioning of nasogastric tubes prior to feeding as the key behavior to target. Questionnaire results indicated differences in key barriers between organizations. Focus groups generated innovative, generalizable, and adaptable strategies for overcoming barriers, such as awareness events, screensavers, equipment modifications, and interactive learning resources. Exit interviews identified themes relating to the benefits, challenges, and sustainability of this approach. Time trend audit data were collected for 301 patients over an 18-month period for one Trust, suggesting clinically significant improved use of pH and documentation of practice following the intervention. The TDF is a feasible and acceptable framework to guide the implementation of patient safety interventions. The stepped TDFI approach engages healthcare professionals and facilitates contextualization in identifying the target behavior, eliciting local barriers, and selecting strategies to address those barriers. This approach may be of use to implementation teams and policy makers, although our promising findings confirm the need for a more rigorous evaluation; a balanced block evaluation is currently underway.

 


A Technological Innovation to Reduce Prescribing Errors Based on Implementation Intentions: The Acceptability and Feasibility of MyPrescribe.

Chris Keyworth, Jo Hart, Hong Thoong, Jane Ferguson, Mary Tully

JMIR human factors [4:e17] (2017)

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Although prescribing of medication in hospitals is rarely an error-free process, prescribers receive little feedback on their mistakes and ways to change future practices. Audit and feedback interventions may be an effective approach to modifying the clinical practice of health professionals, but these may pose logistical challenges when used in hospitals. Moreover, such interventions are often labor intensive. Consequently, there is a need to develop effective and innovative interventions to overcome these challenges and to improve the delivery of feedback on prescribing. Implementation intentions, which have been shown to be effective in changing behavior, link critical situations with an appropriate response; however, these have rarely been used in the context of improving prescribing practices. Semistructured qualitative interviews were conducted to evaluate the acceptability and feasibility of providing feedback on prescribing errors via MyPrescribe, a mobile-compatible website informed by implementation intentions. Data relating to 200 prescribing errors made by 52 junior doctors were collected by 11 hospital pharmacists. These errors were populated into MyPrescribe, where prescribers were able to construct their own personalized action plans. Qualitative interviews with a subsample of 15 junior doctors were used to explore issues regarding feasibility and acceptability of MyPrescribe and their experiences of using implementation intentions to construct prescribing action plans. Framework analysis was used to identify prominent themes, with findings mapped to the behavioral components of the COM-B model (capability, opportunity, motivation, and behavior) to inform the development of future interventions. MyPrescribe was perceived to be effective in providing opportunities for critical reflection on prescribing errors and to complement existing training (such as junior doctors' e-portfolio). The participants were able to provide examples of how they would use "If-Then" plans for patient management. Technology, as opposed to other methods of learning (eg, traditional "paper based" learning), was seen as a positive advancement for continued learning. MyPrescribe was perceived as an acceptable and feasible learning tool for changing prescribing practices, with participants suggesting that it would make an important addition to medical prescribers' training in reflective practice. MyPrescribe is a novel theory-based technological innovation that provides the platform for doctors to create personalized implementation intentions. Applying the COM-B model allows for a more detailed understanding of the perceived mechanisms behind prescribing practices and the ways in which interventions aimed at changing professional practice can be implemented.

 


Bridging the gap between pragmatic intervention design and theory: using behavioural science tools to modify an existing quality improvement programme to implement "Sepsis Six".

Siri Steinmo, Susan Michie, Christopher Fuller, Sarah Stanley, Caitriona Stapleton, Sheldon Stone

Implementation science : IS [11:14] (2016)

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Sepsis has a mortality rate of 40 %, which can be halved if the evidence-based "Sepsis Six" care bundle is implemented within 1 h. UK audit shows low implementation rates. Interventions to improve this have had minimal effects. Quality improvement programmes could be further developed by using theoretical frameworks (Theoretical Domains Framework (TDF)) to modify existing interventions by identifying influences on clinical behaviour and selecting appropriate content. The aim of this study was to illustrate using this process to modify an intervention designed using plan-do-study-act (P-D-S-A) cycles that had achieved partial success in improving Sepsis Six implementation in one hospital. Factors influencing implementation were investigated using the TDF to analyse interviews with 34 health professionals. The nursing team who developed and facilitated the intervention used the data to select modifications using the Behaviour Change Technique (BCT) Taxonomy (v1) and the APEASE criteria: affordability, practicability, effectiveness, acceptability, safety and equity. Five themes were identified as influencing implementation and guided intervention modification. These were:(1) "knowing what to do and why" (TDF domains knowledge, social/professional role and identity); (2) "risks and benefits" (beliefs about consequences), e.g. fear of harming patients through fluid overload acting as a barrier to implementation versus belief in the bundle's effectiveness acting as a lever to implementation; (3) "working together" (social influences, social/professional role and identity), e.g. team collaboration acting as a lever versus doctor/nurse conflict acting as a barrier; (4) "empowerment and support" (beliefs about capabilities, social/professional role and identity, behavioural regulation, social influences), e.g. involving staff in intervention development acting as a lever versus lack of confidence to challenge colleagues' decisions not to implement acting as a barrier; (5) "staffing levels" (environmental context and resources), e.g. shortages of doctors at night preventing implementation. The modified intervention included six new BCTs and consisted of two additional components (Sepsis Six training for the Hospital at Night Co-ordinator; a partnership agreement endorsing engagement of all clinical staff and permitting collegial challenge) and modifications to two existing components (staff education sessions; documents and materials). This work demonstrates the feasibility of the TDF and BCT Taxonomy (v1) for developing an existing quality improvement intervention. The tools are compatible with the pragmatic P-D-S-A cycle approach generally used in quality improvement work.

 


Time for action-Improving the design and reporting of behaviour change interventions for antimicrobial stewardship in hospitals: Early findings from a systematic review.

Peter Davey, Claire Peden, Esmita Charani, Charis Marwick, Susan Michie

International journal of antimicrobial agents [45:203-12] (2015)

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There is strong evidence that self-monitoring and feedback are effective behaviour change techniques (BCTs) across a range of healthcare interventions and that their effectiveness is enhanced by goal setting and action planning. Here we report a summary of the update of a systematic review assessing the application of these BCTs to improving hospital antibiotic prescribing. This paper includes studies with valid prescribing outcomes published before the end of December 2012. We used a structured method for reporting these BCTs in terms of specific characteristics and contacted study authors to request additional intervention information. We identified 116 studies reporting 123 interventions. Reporting of BCTs was poor, with little detail of BCT characteristics. Feedback was only reported for 17 (13.8%) of the interventions, and self-monitoring was used in only 1 intervention. Goals were reported for all interventions but were poorly specified, with only three of the nine characteristics reported for ≥50% of interventions. A goal threshold and timescale were specified for just 1 of the 123 interventions. Only 29 authors (25.0%) responded to the request for additional information. In conclusion, both the content and reporting of interventions for antimicrobial stewardship fell short of scientific principles and practices. There is a strong evidence base regarding BCTs in other contexts that should be applied to antimicrobial stewardship now if we are to further our understanding of what works, for whom, why and in what contexts.

 


Interventions to enhance effective communication during over-the-counter consultations in the community pharmacy setting: A systematic review.

Liza Seubert, Kerry Whitelaw, Laetitia Hattingh, Margaret Watson, Rhonda Clifford

Research in social & administrative pharmacy : RSAP (2017)

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Easy access to effective over-the-counter (OTC) treatments allows self-management of some conditions, however inappropriate or incorrect supply or use of OTC medicines can cause harm. Pharmacy personnel should support consumers in their health-seeking behaviour by utilising effective communication skills underpinned by clinical knowledge. To identify interventions targeted towards improving communication between consumers and pharmacy personnel during OTC consultations in the community pharmacy setting. Systematic review and narrative analysis. Databases searched were MEDLINE, EMBASE, Psycinfo, Cochrane Central Register and Cochrane Database of Systematic Reviews for literature published between 2000 and 30 October 2014, as well as reference lists of included articles. The search was re-run on 18 January 2016 and 25 September 2017 to maximise the currency. Two reviewers independently screened retrieved articles for inclusion, assessed study quality and extracted data. Full publications of intervention studies were included. Participants were community pharmacy personnel and/or consumers involved in OTC consultations. Interventions which aimed to improve communication during OTC consultations in the community pharmacy setting were included if they involved a direct measurable communication outcome. Studies reporting attitudes and measures not quantifiable were excluded. The protocol was published on Prospero Database of Systematic Reviews. Of 4978 records identified, 11 studies met inclusion criteria. Interventions evaluated were: face-to-face training sessions (n = 10); role-plays (n = 9); a software decision making program (n = 1); and simulated patient (SP) visits followed by immediate feedback (n = 1). Outcomes were measured using: SP methodology (n = 10) and a survey (n = 1), with most (n = 10) reporting a level of improvement in some communication behaviours. Empirical evaluation of interventions using active learning techniques such as face-to-face training with role-play can improve some communication skills. However interventions that are not fully described limit the ability for replication and/or generalisability. This review identified interventions targeting pharmacy personnel. Future interventions to improve communication should consider the consumer's role in OTC consultations.

 


Identifying the barriers and enablers for a triage, treatment, and transfer clinical intervention to manage acute stroke patients in the emergency department: a systematic review using the theoretical domains framework (TDF).

Louise Craig, Elizabeth McInnes, Natalie Taylor, Rohan Grimley, Dominique Cadilhac, Julie Considine, Sandy Middleton

Implementation science : IS [11:157] (2016)

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Clinical guidelines recommend that assessment and management of patients with stroke commences early including in emergency departments (ED). To inform the development of an implementation intervention targeted in ED, we conducted a systematic review of qualitative and quantitative studies to identify relevant barriers and enablers to six key clinical behaviours in acute stroke care: appropriate triage, thrombolysis administration, monitoring and management of temperature, blood glucose levels, and of swallowing difficulties and transfer of stroke patients in ED. Studies of any design, conducted in ED, where barriers or enablers based on primary data were identified for one or more of these six clinical behaviours. Major biomedical databases (CINAHL, OVID SP EMBASE, OVID SP MEDLINE) were searched using comprehensive search strategies. The barriers and enablers were categorised using the theoretical domains framework (TDF). The behaviour change technique (BCT) that best aligned to the strategy each enabler represented was selected for each of the reported enablers using a standard taxonomy. Five qualitative studies and four surveys out of the 44 studies identified met the selection criteria. The majority of barriers reported corresponded with the TDF domains of "environmental, context and resources" (such as stressful working conditions or lack of resources) and "knowledge" (such as lack of guideline awareness or familiarity). The majority of enablers corresponded with the domains of "knowledge" (such as education for physicians on the calculated risk of haemorrhage following intravenous thrombolysis [tPA]) and "skills" (such as providing opportunity to treat stroke cases of varying complexity). The total number of BCTs assigned was 18. The BCTs most frequently assigned to the reported enablers were "focus on past success" and "information about health consequences." Barriers and enablers for the delivery of key evidence-based protocols in an emergency setting have been identified and interpreted within a relevant theoretical framework. This new knowledge has since been used to select specific BCTs to implement evidence-based care in an ED setting. It is recommended that findings from similar future reviews adopt a similar theoretical approach. In particular, the use of existing matrices to assist the selection of relevant BCTs.

 


Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) a pragmatic three-arm cluster randomised trial: designing the intervention (ClinicalTrials.gov registration NCT01602705).

Karen Barnett, Marion Bennie, Shaun Treweek, Christopher Robertson, Dennis Petrie, Lewis Ritchie, Bruce Guthrie

Implementation science : IS [9:133] (2014)

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High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices. The NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: (1) educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study. Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2×). The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings. ClinicalTrials.gov: NCT01602705.

 


Paper-based and web-based intervention modeling experiments identified the same predictors of general practitioners' antibiotic-prescribing behavior.

Shaun Treweek, Debbie Bonetti, Graeme Maclennan, Karen Barnett, Martin Eccles, Claire Jones, Nigel Pitts, Ian Ricketts, Frank Sullivan, Mark Weal, Jill Francis

Journal of clinical epidemiology [67:296-304] (2014)

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To evaluate the robustness of the intervention modeling experiment (IME) methodology as a way of developing and testing behavioral change interventions before a full-scale trial by replicating an earlier paper-based IME. Web-based questionnaire and clinical scenario study. General practitioners across Scotland were invited to complete the questionnaire and scenarios, which were then used to identify predictors of antibiotic-prescribing behavior. These predictors were compared with the predictors identified in an earlier paper-based IME and used to develop a new intervention. Two hundred seventy general practitioners completed the questionnaires and scenarios. The constructs that predicted simulated behavior and intention were attitude, perceived behavioral control, risk perception/anticipated consequences, and self-efficacy, which match the targets identified in the earlier paper-based IME. The choice of persuasive communication as an intervention in the earlier IME was also confirmed. Additionally, a new intervention, an action plan, was developed. A web-based IME replicated the findings of an earlier paper-based IME, which provides confidence in the IME methodology. The interventions will now be evaluated in the next stage of the IME, a web-based randomized controlled trial.

 


Development of a behaviour change intervention: a case study on the practical application of theory.

Mark Porcheret, Chris Main, Peter Croft, Robert McKinley, Andrew Hassell, Krysia Dziedzic

Implementation science : IS [9:42] (2014)

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Use of theory in implementation of complex interventions is widely recommended. A complex trial intervention, to enhance self-management support for people with osteoarthritis (OA) in primary care, needed to be implemented in the Managing Osteoarthritis in Consultations (MOSAICS) trial. One component of the trial intervention was delivery by general practitioners (GPs) of an enhanced consultation for patients with OA. The aim of our case study is to describe the systematic selection and use of theory to develop a behaviour change intervention to implement GP delivery of the enhanced consultation. The development of the behaviour change intervention was guided by four theoretical models/frameworks: i) an implementation of change model to guide overall approach, ii) the Theoretical Domains Framework (TDF) to identify relevant determinants of change, iii) a model for the selection of behaviour change techniques to address identified determinants of behaviour change, and iv) the principles of adult learning. Methods and measures to evaluate impact of the behaviour change intervention were identified. The behaviour change intervention presented the GPs with a well-defined proposal for change; addressed seven of the TDF domains (e.g., knowledge, skills, motivation and goals); incorporated ten behaviour change techniques (e.g., information provision, skills rehearsal, persuasive communication); and was delivered in workshops that valued the expertise and professional values of GPs. The workshops used a mixture of interactive and didactic sessions, were facilitated by opinion leaders, and utilised 'context-bound communication skills training.' Methods and measures selected to evaluate the behaviour change intervention included: appraisal of satisfaction with workshops, GP report of intention to practise and an assessment of video-recorded consultations of GPs with patients with OA. A stepped approach to the development of a behaviour change intervention, with the utilisation of theoretical frameworks to identify determinants of change matched with behaviour change techniques, has enabled a systematic and theory-driven development of an intervention designed to enhance consultations by GPs for patients with OA. The success of the behaviour change intervention in practice will be evaluated in the context of the MOSAICS trial as a whole, and will inform understanding of practice level and patient outcomes in the trial.

 


Developing a targeted, theory-informed implementation intervention using two theoretical frameworks to address health professional and organisational factors: a case study to improve the management of mild traumatic brain injury in the emergency department.

Emma Tavender, Marije Bosch, Russell Gruen, Sally Green, Susan Michie, Sue Brennan, Jill Francis, Jennie Ponsford, Jonathan Knott, Sue Meares, Tracy Smyth, Denise O'Connor

Implementation science : IS [10:74] (2015)

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Despite the availability of evidence-based guidelines for the management of mild traumatic brain injury in the emergency department (ED), variations in practice exist. Interventions designed to implement recommended behaviours can reduce this variation. Using theory to inform intervention development is advocated; however, there is no consensus on how to select or apply theory. Integrative theoretical frameworks, based on syntheses of theories and theoretical constructs relevant to implementation, have the potential to assist in the intervention development process. This paper describes the process of applying two theoretical frameworks to investigate the factors influencing recommended behaviours and the choice of behaviour change techniques and modes of delivery for an implementation intervention. A stepped approach was followed: (i) identification of locally applicable and actionable evidence-based recommendations as targets for change, (ii) selection and use of two theoretical frameworks for identifying barriers to and enablers of change (Theoretical Domains Framework and Model of Diffusion of Innovations in Service Organisations) and (iii) identification and operationalisation of intervention components (behaviour change techniques and modes of delivery) to address the barriers and enhance the enablers, informed by theory, evidence and feasibility/acceptability considerations. We illustrate this process in relation to one recommendation, prospective assessment of post-traumatic amnesia (PTA) by ED staff using a validated tool. Four recommendations for managing mild traumatic brain injury were targeted with the intervention. The intervention targeting the PTA recommendation consisted of 14 behaviour change techniques and addressed 6 theoretical domains and 5 organisational domains. The mode of delivery was informed by six Cochrane reviews. It was delivered via five intervention components : (i) local stakeholder meetings, (ii) identification of local opinion leader teams, (iii) a train-the-trainer workshop for appointed local opinion leaders, (iv) local training workshops for delivery by trained local opinion leaders and (v) provision of tools and materials to prompt recommended behaviours. Two theoretical frameworks were used in a complementary manner to inform intervention development in managing mild traumatic brain injury in the ED. The effectiveness and cost-effectiveness of the developed intervention is being evaluated in a cluster randomised trial, part of the Neurotrauma Evidence Translation (NET) program.

 


Use of the theoretical domains framework to develop an intervention to improve physical therapist management of the risk of falls after discharge.

S Thomas, S Mackintosh

Physical therapy [94:1660-75] (2014)

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Older adults have an increased risk of falls after discharge from the hospital. Guidelines to manage this risk of falls are well documented but are not commonly implemented. The aim of this case report is to describe the novel approach of using the Theoretical Domains Framework (TDF) to develop an intervention to change the clinical behavior of physical therapists. This project had 4 phases: identifying the evidence-practice gap, identifying barriers and enablers that needed to be addressed, identifying behavior change techniques to overcome the barriers, and determining outcome measures for evaluating behavior change. The evidence-practice gap was represented by the outcome that few patients who had undergone surgery for hip fracture were recognized as having a risk of falls or had a documented referral to a community agency for follow-up regarding the prevention of falls. Project aims aligned with best practice guidelines were established; 12 of the 14 TDF domains were considered to be relevant to behaviors in the project, and 6 behavior change strategies were implemented. Primary outcome measures included the proportion of patients who had documentation of the risk of falls and were referred for a comprehensive assessment of the risk of falls after discharge from the hospital. A systematic approach involving the TDF was useful for designing a multifaceted intervention to improve physical therapist management of the risk of falls after discharge of patients from an acute care setting in South Australia, Australia. This framework enabled the identification of targeted intervention strategies that were likely to influence health care professional behavior. Early case note audit results indicated that positive changes were being made to reduce the evidence-practice gap.

 


Improving correctional healthcare providers' ability to care for transgender patients: Development and evaluation of a theory-driven cultural and clinical competence intervention.

Hughto White, M Jaclyn, Kirsty Clark, Frederick Altice, Sari Reisner, Trace Kershaw, John Pachankis

Social science & medicine (1982) [195:159-169] (2017)

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Correctional healthcare providers' limited cultural and clinical competence to care for transgender patients represents a barrier to care for incarcerated transgender individuals. The present study aimed to adapt, deliver, and evaluate a transgender cultural and clinical competence intervention for correctional healthcare providers. In the summer of 2016, a theoretically-informed, group-based intervention to improve transgender cultural and clinical competence was delivered to 34 correctional healthcare providers in New England. A confidential survey assessed providers' cultural and clinical competence to care for transgender patients, self-efficacy to provide hormone therapy, subjective norms related to transgender care, and willingness to provide gender-affirming care to transgender patients before and after (immediately and 3-months) the intervention. Linear mixed effects regression models were fit to assess change in study outcomes over time. Qualitative exit interviews assessed feasibility and acceptability of the intervention. Providers' willingness to provide gender-affirming care improved immediately post-intervention (β = 0.38; SE = 0.41, p < 0.001) and from baseline to 3-months post-intervention (β = 0.36; SE = 0.09; p < 0.001; omnibus test of fixed effects χ = 23.21; p < 0.001). On average, transgender cultural competence (χ = 22.49; p < 0.001), medical gender affirmation knowledge (χ = 11.24; p = 0.01), self-efficacy to initiate hormones for transgender women, and subjective norms related to transgender care (χ = 14.69; p = 0.001) all significantly increased over time. Providers found the intervention to be highly acceptable and recommended that the training be scaled-up to other correctional healthcare providers and expanded to custody staff. The intervention increased correctional healthcare providers' cultural and clinical competence, self-efficacy, subjective norms, and willingness to provide gender-affirming care to transgender patients. Continued efforts should be made to train correctional healthcare providers in culturally and clinically competent gender-affirming care in order to improve the health of incarcerated transgender people. Future efficacy testing of this intervention is warranted.

 


General practitioner views on the determinants of test ordering: a theory-based qualitative approach to the development of an intervention to improve immunoglobulin requests in primary care.

S Cadogan, S McHugh, C Bradley, J Browne, M Cahill

Implementation science : IS [11:102] (2016)

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Research suggests that variation in laboratory requesting patterns may indicate unnecessary test use. Requesting patterns for serum immunoglobulins vary significantly between general practitioners (GPs). This study aims to explore GP's views on testing to identify the determinants of behaviour and recommend feasible intervention strategies for improving immunoglobulin test use in primary care. Qualitative semi-structured interviews were conducted with GPs requesting laboratory tests at Cork University Hospital or University Hospital Kerry in the South of Ireland. GPs were identified using a Health Service Executive laboratory list of GPs in the Cork-Kerry region. A random sample of GPs (stratified by GP requesting patterns) was generated from this list. GPs were purposively sampled based on the criteria of location (urban/rural); length of time qualified; and practice size (single-handed/group). Interviews were carried out between December 2014 and February 2015. Interviews were transcribed verbatim using NVivo 10 software and analysed using the framework analysis method. Emerging themes were mapped to the theoretical domains framework (TDF), which outlines 12 domains that can enable or inhibit behaviour change. The behaviour change wheel and behaviour change technique (BCT) taxonomy were then used to identify potential intervention strategies. Sixteen GPs were interviewed (ten males and six females). Findings suggest that intervention strategies should specifically target the key barriers to effective test ordering, while considering the context of primary care practice. Seven domains from the TDF were perceived to influence immunoglobulin test ordering behaviours and were identified as 'mechanisms for change' (knowledge, environmental context and resources, social/professional role and identity, beliefs about capabilities, beliefs about consequences, memory, attention and decision-making processes and behavioural regulation). Using these TDF domains, seven BCTs emerged as feasible 'intervention content' for targeting GPs' ordering behaviour. These included instructions on how to effectively request the test (how to perform behaviour), information on GPs' use of the test (feedback on behaviour), information about patient consequences resulting from not doing the test (information about health consequences), laboratory/consultant-based advice/education (credible source), altering the test ordering form (restructuring the physical environment), providing guidelines (prompts/cues) and adding interpretive comments to the results (adding objects to the environment). These BCTs aligned to four intervention functions: education, persuasion, environmental restructuring and enablement. This study has effectively applied behaviour change theory to identify feasible strategies for improving immunoglobulin test use in primary care using the TDF, 'behaviour change wheel' and BCT taxonomy. The identified BCTs will form the basis of a theory-based intervention to improve the use of immunoglobulin tests among GPs. Future research will involve the development and evaluation of this intervention.

 


Specifying content and mechanisms of change in interventions to change professionals' practice: an illustration from the Good Goals study in occupational therapy.

N Kolehmainen, JJ Francis

Implementation science : IS [7:100] (2012)

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It is widely agreed that interventions to change professionals' practice need to be clearly specified. This involves (1) selecting and defining the intervention techniques, (2) operationalising the techniques and deciding their delivery, and (3) formulating hypotheses about the mechanisms through which the techniques are thought to result in change. Descriptions of methods to achieve these objectives are limited. This paper reports methods and illustrates outputs from a study to meet these objectives, specifically from the Good Goals study to improve occupational therapists' caseload management practice. (1) Behaviour change techniques were identified and selected from an existing matrix that maps techniques to determinants. An existing coding manual was used to define the techniques. (2) A team of occupational therapists generated context-relevant, acceptable modes of delivery for the techniques; these data were compared and contrasted with previously collected data, literature on caseload management, and the aims of the intervention. (3) Hypotheses about the mechanisms of change were formulated by drawing on the matrix and on theories of behaviour change. (1) Eight behaviour change techniques were selected: goal specified; self-monitoring; contract; graded tasks; increasing skills (problem solving, decision making, goal setting); coping skills; rehearsal of relevant skills; social processes of encouragement, support, and pressure; demonstration by others; and feedback. (2) A range of modes of delivery were generated (e.g., graded tasks' consisting of series of clinical cases and situations that become increasingly difficult). Conditions for acceptable delivery were identified (e.g., 'self-monitoring' was acceptable only if delivered at team level). The modes of delivery were specified as face-to-face training, task sheets, group tasks, DVDs, and team-based weekly meetings. (3) The eight techniques were hypothesized to target caseload management practice through eleven mediating variables. Three domains were hypothesized to be most likely to change: beliefs about capabilities, motivation and goals, and behavioural regulation. The project provides an exemplar of a systematic and reportable development of a quality-improvement intervention, with its methods likely to be applicable to other projects. A subsequent study of the intervention has provided early indication that use of systematic methods to specify interventions may help to maximize acceptability and effectiveness.

 



An Audit and Feedback Intervention for Reducing Antibiotic Prescribing in General Dental Practice: The RAPiD Cluster Randomised Controlled Trial.

Paula Elouafkaoui, Linda Young, Rumana Newlands, Eilidh Duncan, Andrew Elders, Jan Clarkson, Craig Ramsay

PLoS medicine [13:e1002115] (2016)

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Dentists prescribe approximately 10% of antibiotics dispensed in UK community pharmacies. Despite clear clinical guidance, dentists often prescribe antibiotics inappropriately. This cluster-randomised controlled trial used routinely collected National Health Service (NHS) dental prescribing and treatment claim data to compare the impact of individualised audit and feedback (A&F) interventions on dentists' antibiotic prescribing rates. All 795 antibiotic prescribing NHS general dental practices in Scotland were included. Practices were randomised to the control (practices = 163; dentists = 567) or A&F intervention group (practices = 632; dentists = 1,999). A&F intervention practices were allocated to one of two A&F groups: (1) individualised graphical A&F comprising a line graph plotting an individual dentist's monthly antibiotic prescribing rate (practices = 316; dentists = 1,001); or (2) individualised graphical A&F plus a written behaviour change message synthesising and reiterating national guidance recommendations for dental antibiotic prescribing (practices = 316; dentists = 998). Intervention practices were also simultaneously randomised to receive A&F: (i) with or without a health board comparator comprising the addition of a line to the graphical A&F plotting the monthly antibiotic prescribing rate of all dentists in the health board; and (ii) delivered at 0 and 6 mo or at 0, 6, and 9 mo, giving a total of eight intervention groups. The primary outcome, measured by the trial statistician who was blinded to allocation, was the total number of antibiotic items dispensed per 100 NHS treatment claims over the 12 mo post-delivery of the baseline A&F. Primary outcome data was available for 152 control practices (dentists = 438) and 609 intervention practices (dentists = 1,550). At baseline, the number of antibiotic items prescribed per 100 NHS treatment claims was 8.3 in the control group and 8.5 in the intervention group. At follow-up, antibiotic prescribing had decreased by 0.4 antibiotic items per 100 NHS treatment claims in control practices and by 1.0 in intervention practices. This represents a significant reduction (-5.7%; 95% CI -10.2% to -1.1%; p = 0.01) in dentists' prescribing rate in the intervention group relative to the control group. Intervention subgroup analyses found a 6.1% reduction in the antibiotic prescribing rate of dentists who had received the written behaviour change message relative to dentists who had not (95% CI -10.4% to -1.9%; p = 0.01). There was no significant between-group difference in the prescribing rate of dentists who received a health board comparator relative to those who did not (-4.3%; 95% CI -8.6% to 0.1%; p = 0.06), nor between dentists who received A&F at 0 and 6 mo relative to those who received A&F at 0, 6, and 9 mo (0.02%; 95% CI -4.2% to 4.2%; p = 0.99). The key limitations relate to the use of routinely collected datasets which did not allow evaluation of any effects on inappropriate prescribing. A&F derived from routinely collected datasets led to a significant reduction in the antibiotic prescribing rate of dentists. Current Controlled Trials ISRCTN49204710.

 


The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.

Ben Darlow, James Stanley, Sarah Dean, J Haxby Abbott, Sue Garrett, Fiona Mathieson, Anthony Dowell

Trials [18:484] (2017)

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Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psychosocial barriers to recovery and provision of evidence-based care and information. The aim of the Low Back Pain in General Practice (LBPinGP) trial is to explore whether patients with LBP who receive care from GPs trained in the FREE approach have better outcomes than those who receive usual care. This is a cluster randomised controlled superiority trial comparing the FREE approach with usual care for LBP management with investigator-blinded assessment of outcomes. GPs will be recruited and then cluster randomised (in practice groups) to the intervention or control arm. Intervention arm GPs will receive training in the FREE approach, and control arm GPs will continue to practice as usual. Patients presenting to their GP with a primary complaint of LBP will be allocated on the basis of allocation of the GP they consult. We aim to recruit 60 GPs and 275 patients (assuming patients are recruited from 75% of GPs and an average of 5 patients per GP complete the study, accounting for 20% patient participant dropout). Patient participants and the trial statistician will be blind to group allocation throughout the study. Analyses will be undertaken on an intention-to-treat basis. The primary outcome will be back-related functional impairment 6 months post-initial LBP consultation (interim data at 2 weeks, 6 weeks and 3 months), measured with the Roland-Morris Disability Questionnaire. Secondary patient outcomes include pain, satisfaction, quality of life, days off from work and costs of care. Secondary GP outcomes include beliefs about pain and impairment, GP confidence, and actual and reported clinical behaviour. Health economic and process evaluations will be conducted. In the LBPinGP trial, we will investigate providing an intervention during the first interaction a person with back pain has with their GP. Because the FREE approach is used within a normal GP consultation, if effective, it may be a cost-effective means of improving LBP care. Australian New Zealand Clinical Trials Registry, ACTRN12616000888460 . Registered on 6 July 2016.

 


Applying the Theoretical Domains Framework to identify barriers and targeted interventions to enhance nurses' use of electronic medication management systems in two Australian hospitals.

Deborah Debono, Natalie Taylor, Wendy Lipworth, David Greenfield, Joanne Travaglia, Deborah Black, Jeffrey Braithwaite

Implementation science : IS [12:42] (2017)

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Medication errors harm hospitalised patients and increase health care costs. Electronic Medication Management Systems (EMMS) have been shown to reduce medication errors. However, nurses do not always use EMMS as intended, largely because implementation of such patient safety strategies requires clinicians to change their existing practices, routines and behaviour. This study uses the Theoretical Domains Framework (TDF) to identify barriers and targeted interventions to enhance nurses' appropriate use of EMMS in two Australian hospitals. This qualitative study draws on in-depth interviews with 19 acute care nurses who used EMMS. A convenience sampling approach was used. Nurses working on the study units (N = 6) in two hospitals were invited to participate if available during the data collection period. Interviews inductively explored nurses' experiences of using EMMS (step 1). Data were analysed using the TDF to identify theory-derived barriers to nurses' appropriate use of EMMS (step 2). Relevant behaviour change techniques (BCTs) were identified to overcome key barriers to using EMMS (step 3) followed by the identification of potential literature-informed targeted intervention strategies to operationalise the identified BCTs (step 4). Barriers to nurses' use of EMMS in acute care were represented by nine domains of the TDF. Two closely linked domains emerged as major barriers to EMMS use: Environmental Context and Resources (availability and properties of computers on wheels (COWs); technology characteristics; specific contexts; competing demands and time pressure) and Social/Professional Role and Identity (conflict between using EMMS appropriately and executing behaviours critical to nurses' professional role and identity). The study identified three potential BCTs to address the Environmental Context and Resources domain barrier: adding objects to the environment; restructuring the physical environment; and prompts and cues. Seven BCTs to address Social/Professional Role and Identity were identified: social process of encouragement; pressure or support; information about others' approval; incompatible beliefs; identification of self as role model; framing/reframing; social comparison; and demonstration of behaviour. It proposes several targeted interventions to deliver these BCTs. The TDF provides a useful approach to identify barriers to nurses' prescribed use of EMMS, and can inform the design of targeted theory-based interventions to improve EMMS implementation.

 


Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework.

Simon French, Sally Green, Denise O'Connor, Joanne McKenzie, Jill Francis, Susan Michie, Rachelle Buchbinder, Peter Schattner, Neil Spike, Jeremy Grimshaw

Implementation science : IS [7:38] (2012)

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There is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. This article is one in a Series of articles documenting the development and use of the Theoretical Domains Framework (TDF) to advance the science of implementation research. The intervention was developed considering three main components: theory, evidence, and practical issues. We used a four-step approach, consisting of guiding questions, to direct the choice of the most appropriate components of an implementation intervention: Who needs to do what, differently? Using a theoretical framework, which barriers and enablers need to be addressed? Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? And how can behaviour change be measured and understood? A complex implementation intervention was designed that aimed to improve acute low back pain management in primary care. We used the TDF to identify the barriers and enablers to the uptake of evidence into practice and to guide the choice of intervention components. These components were then combined into a cohesive intervention. The intervention was delivered via two facilitated interactive small group workshops. We also produced a DVD to distribute to all participants in the intervention group. We chose outcome measures in order to assess the mediating mechanisms of behaviour change. We have illustrated a four-step systematic method for developing an intervention designed to change clinical practice based on a theoretical framework. The method of development provides a systematic framework that could be used by others developing complex implementation interventions. While this framework should be iteratively adjusted and refined to suit other contexts and settings, we believe that the four-step process should be maintained as the primary framework to guide researchers through a comprehensive intervention development process.