Implementation science and psycho-oncology: Advancing the translation of evidence into practice.

OBJECTIVES: This Special issue of Psycho-Oncology highlights examples of the application of implementation science to research in psycho-oncology. The aim is to demonstrate the different ways that implementation science is being used to generate evidence that can more readily translate evidence into changes in clinical practice. We hope this issue fosters greater interest in using the tools of implementation science to improve the lives of people affected by cancer. METHODS: The papers in the issue were selected from among those that responded to a call for submissions on the application of implementation science frameworks and methods to issues in psycho-oncology. The focus included but was not limited to research on: understanding barriers and facilitators of intervention/practice adoption; assessing implementation outcomes, evaluating implementation strategies, and improving behavioural and/or clinical outcomes. RESULTS: The 11 papers in this issue were grouped for presentation purposes into four common topics: barriers and facilitators to implementation; feasibility as a key implementation outcome; the design, selection and adaptation of implementation strategies; and building the foundation for psycho-oncology research translation via systematic reviews that focus on implementation strategy design. CONCLUSION: These papers demonstrate the breadth of current applications of implementation science to research in psycho-oncology. Alongside the studies featured in this issue, including cost-effectiveness analyses, tests of nationally-focused strategies and proactive planning for adaptation, we look forward to other innovations that will promote further growth of both disciplines to improve the integration of psycho-oncology interventions across healthcare systems.

Integrating design thinking and implementation science principles in delivering a medication review service in the community pharmacy setting-An implementation testing study.

BACKGROUND: Medication review (MR) services are evidenced-based practices in which a systematic assessment of a patient's medication is conducted, primarily aiming to optimize drug therapy and minimize adverse drug events through pharmacist interventions. Although studies show that MR services are effective, the implementation of MR services in Malaysia has been challenging due to several barriers. An MR services blueprint was developed to be adapted to the Malaysian community pharmacy setting as part of tailoring strategies. OBJECTIVE: Through utilizing the design thinking triple diamond model and implementation science principles, a powerful guide for healthcare researchers and stakeholders to assist with effective service implementation, this study aimed to evaluate the implementation testing and observe the effectiveness of the developed MR service blueprint. METHOD: The study utilizes an effectiveness-implementation Type 3 hybrid implementation science framework conducted from May 2021 to April 2022. Employing a qualitative ethnographic approach, researchers observed pharmacy study sites during the implementation of MR services. Both qualitative and quantitative data were collected across exploration, preparation, testing, and operational phases. Implementation outcomes evaluated include phases, reach, fidelity, acceptability, as well as implementation barriers and strategies. MR intervention outcomes included service characteristics and the number and type of drug-related problems and interventions offered. RESULTS: 17 community pharmacists were invited to pilot the MR service blueprint for six months in their setting. Of this, 78.5% (n = 11) of the pharmacies reached the testing phase, and 36% (n = 4) reached the implementation phase. Fifty-four patients were in the study, giving an implementation reach of 70%. The majority of surveyed patients expressed satisfaction with the service. The total DRP identified was 133, and 64 interventions were provided by the pharmacists. Facilitation strategies such as "Engage stakeholders by creating ownership of the change" and "Equip stakeholders with training" are needed to overcome the barriers. CONCLUSION: This study marked the beginning of successful MR service implementation at Malaysian community pharmacies. Future studies with multi-level partnered strategies are required to reach full implementation and sustainability.

A data-driven approach to implementing the HPTN 094 complex intervention INTEGRA in local communities.

BACKGROUND: HIV burden in the US among people who inject drugs (PWID) is driven by overlapping syndemic factors such as co-occurring health needs and environmental factors that synergize to produce worse health outcomes among PWID. This includes stigma, poverty, and limited healthcare access (e.g. medication to treat/prevent HIV and for opioid use disorder [MOUD]). Health services to address these complex needs, when they exist, are rarely located in proximity to each other or to the PWID who need them. Given the shifting drug use landscapes and geographic heterogeneity in the US, we evaluate a data-driven approach to guide the delivery of such services to PWID in local communities. METHODS: We used a hybrid, type I, embedded, mixed method, data-driven approach to identify and characterize viable implementation neighborhoods for the HPTN 094 complex intervention, delivering integrated MOUD and HIV treatment/prevention through a mobile unit to PWID across five US cities. Applying the PRISM framework, we triangulated geographic and observational pre-implementation phase data (epidemiological overdose and HIV surveillance data) with two years of implementation phase data (weekly ecological assessments, study protocol meetings) to characterize environmental factors that affected the viability of implementation neighborhoods over time and across diverse settings. RESULTS: Neighborhood-level drug use and geographic diversity alongside shifting socio-political factors (policing, surveillance, gentrification) differentially affected the utility of epidemiological data in identifying viable implementation neighborhoods across sites. In sites where PWID are more geographically dispersed, proximity to structural factors such as public transportation and spaces where PWID reside played a role in determining suitable implementation sites. The utility of leveraging additional data from local overdose and housing response systems to identify viable implementation neighborhoods was mixed. CONCLUSIONS: Our findings suggest that data-driven approaches provide a contextually relevant pragmatic strategy to guide the real-time implementation of integrated care models to better meet the needs of PWID and help inform the scale-up of such complex interventions. This work highlights the utility of implementation science methods that attend to the impact of local community environmental factors on the implementation of complex interventions to PWID across diverse drug use, sociopolitical, and geographic landscapes in the US. TRIAL REGISTRATION: ClincalTrials.gov, Registration Number: NCT04804072 . Registered 18 February 2021.

Offering extended use of the contraceptive implant via an implementation science framework: a qualitative study of clinicians' perceived barriers and facilitators.

BACKGROUND: The etonogestrel contraceptive implant is currently approved by the United States Food and Drug Administration (FDA) for the prevention of pregnancy up to 3 years. However, studies that suggest efficacy up to 5 years. There is little information on the prevalence of extended use and the factors that influence clinicians in offering extended use. We investigated clinician perspectives on the barriers and facilitators to offering extended use of the contraceptive implant. METHODS: Using the Consolidated Framework for Implementation Research (CFIR), we conducted semi-structured qualitative interviews. Participants were recruited from a nationwide survey study of reproductive health clinicians on their knowledge and perspective of extended use of the contraceptive implant. To optimize the diversity of perspectives, we purposefully sampled participants from this study. We used content analysis and consensual qualitative research methods to inform our coding and data analysis. Themes arose deductively and inductively. RESULTS: We interviewed 20 clinicians including advance practice clinicians, family medicine physicians, obstetrician/gynecologist and complex family planning sub-specialists. Themes regarding barriers and facilitators to extended use of the contraceptive implant emerged. Barriers included the FDA approval for 3 years and clinician concern about liability in the context of off-label use of the contraceptive implant. Educational materials and a champion of extended use were facilitators. CONCLUSIONS: There is opportunity to expand access to extended use of the contraceptive implant by developing educational materials for clinicians and patients, identifying a champion of extended use, and providing information on extended use prior to replacement appointments at 3 years.

Adapting and testing measures of organizational context in primary care clinics in KwaZulu-Natal, South Africa.

BACKGROUND: Implementation science frameworks situate intervention implementation and sustainment within the context of the implementing organization and system. Aspects of organizational context such as leadership have been defined and measured largely within US health care settings characterized by decentralization and individual autonomy. The relevance of these constructs in other settings may be limited by differences like collectivist orientation, resource constraints, and hierarchical power structures. We aimed to adapt measures of organizational context in South African primary care clinics. METHODS: We convened a panel of South African experts in social science and HIV care delivery and presented implementation domains informed by existing frameworks and prior work in South Africa. Based on panel input, we selected contextual domains and adapted candidate items. We conducted cognitive interviews with 25 providers in KwaZulu-Natal Province to refine measures. We then conducted a cross-sectional survey of 16 clinics with 5-20 providers per clinic (N = 186). We assessed reliability using Cronbach's alpha and calculated interrater agreement (awg) and intraclass correlation coefficient (ICC) at the clinic level. Within clinics with moderate agreement, we calculated correlation of clinic-level measures with each other and with hypothesized predictors - staff continuity and infrastructure - and a clinical outcome, patient retention on antiretroviral therapy. RESULTS: Panelists emphasized contextual factors; we therefore focused on elements of clinic leadership, stress, cohesion, and collective problem solving (critical consciousness). Cognitive interviews confirmed salience of the domains and improved item clarity. After excluding items related to leaders' coordination abilities due to missingness and low agreement, all other scales demonstrated individual-level reliability and at least moderate interrater agreement in most facilities. ICC was low for most leadership measures and moderate for others. Measures tended to correlate within facility, and higher stress was significantly correlated with lower staff continuity. Organizational context was generally more positively rated in facilities that showed consistent agreement. CONCLUSIONS: As theorized, organizational context is important in understanding program implementation within the South African health system. Most adapted measures show good reliability at individual and clinic levels. Additional revision of existing frameworks to suit this context and further testing in high and low performing clinics is warranted.

Implementing the Brøset Violence Checklist in the ED.

ABSTRACT: The emerging field of implementation science (IS) facilitates the sustainment of evidence-based practice in clinical care. This article, the second in a series on applying IS, describes how a nurse-led IS team at a multisite health system implemented the Brøset Violence Checklist-a validated, evidence-based tool to predict a patient's potential to become violent-in the system's adult EDs, with the aim of decreasing the rate of violence against staff. The authors discuss how they leveraged IS concepts, methods, and tools to achieve this goal.

Cost-A Hidden Aspect of Equity-Grounded Implementation Science.

This JAMA Forum discusses the cost of health inequities, the lack of attention to implementation science and the costs in the research enterprise, and provides recommendations for targeting cost in equity-grounded implementation science.

Scaling up a brief alcohol intervention to prevent HIV infection in Vietnam: a cluster randomized, implementation trial.

BACKGROUND: Evidence-based interventions (EBIs) often address normative behaviors. If a behavior is also common among clinicians, they may be skeptical about the necessity or effectiveness of an EBI. Alternatively, clinicians' attitudes and behaviors may be misaligned, or they may lack the knowledge and self-efficacy to deliver the EBI. Several EBIs address unhealthy alcohol use, a common and often culturally acceptable behavior. But unhealthy alcohol use may be particularly harmful to people with HIV (PWH). Here, we present an implementation trial using an experiential implementation strategy to address clinicians' knowledge, attitudes, and behaviors. Clinicians receive the experiential intervention before they begin delivering an evidence-based brief alcohol intervention (BAI) to PWH with unhealthy alcohol use. METHODS: Design: In this hybrid type 3 implementation-effectiveness cluster randomized controlled trial, ART clinics (n = 30) will be randomized 1:1 to facilitation, a flexible strategy to address implementation barriers, or facilitation plus the experiential brief alcohol intervention (EBAI). In the EBAI arm, clinicians, irrespective of their alcohol use, will be offered the BAI as experiential learning. EBAI will address clinicians' alcohol-related attitudes and behaviors and increase their knowledge and confidence to deliver the BAI. PARTICIPANTS: ART clinic staff will be enrolled and assessed at pre-BAI training, post-BAI training, 3, 12, and 24 months. All PWH at the ART clinics who screen positive for unhealthy alcohol use will be offered the BAI. A subset of PWH (n = 810) will be enrolled and assessed at baseline, 3, and 12 months. OUTCOMES: We will compare implementation outcomes (acceptability, fidelity, penetration, costs, and sustainability) and effectiveness outcomes (viral suppression and alcohol use) between the two arms. We will assess the impact of site-level characteristics on scaling-up the BAI. We will also evaluate how experiencing the BAI affected clinical staff's alcohol use and clinic-level alcohol expectations in the EBAI arm. DISCUSSION: This trial contributes to implementation science by testing a novel strategy to implement a behavior change intervention in a setting in which clinicians themselves may engage in the behavior. Experiential learning may be useful to address normative and difficult to change lifestyle behaviors that contribute to chronic diseases. TRIAL REGISTRATION: NCT06358885 (04/10/2024), https://clinicaltrials.gov/study/NCT06358885 .

Implementation science in humanitarian assistance: applying a novel approach for humanitarian care optimization.

Humanitarian assistance is hindered by a lack of strategies to optimize care delivery through research and organized networks. Distinct from global health, humanitarian assistance struggles to address its multifaceted challenges, including duplicative resources, uncoordinated communication, unregulated staff expertise and safety, financial waste, and poor-quality metrics and care delivery. Implementation science provides an exciting and underutilized approach that can be applied to address these challenges, by studying how to effectively design, implement, optimize, and scale evidence-based interventions. Though successful in well-resourced and global health systems, implementation science approaches are rare in humanitarian assistance. Adopting implementation science approaches including identifying determinants, creating accessible evidence-based intervention bundles, adapting study methodologies for the humanitarian context, and partnering with implementation experts could make these promising approaches more accessible for thousands of humanitarian actors delivering healthcare for millions of vulnerable patients worldwide.

Strengthening healthcare delivery in Rwanda: Implementation science training for reproductive health researchers.

BACKGROUND: Addressing the gap between research and practice is crucial for enhancing reproductive healthcare outcomes. In Rwanda and other low- and middle-income countries, bolstering health researchers' implementation science (IS) capacity is essential. We present a pre-post-intervention study assessing the influence of an intensive IS training program on Rwandan reproductive health researchers' perceived IS knowledge and self-efficacy in applying IS in their own research. METHODS: To introduce IS principles, we held a one-day training for a diverse cohort of 25 sexual and reproductive health researchers in Rwanda. The training encompassed modules on IS concepts, methodologies, and practical applications. Pre- and post-training assessments gauged changes in participants' perceived IS knowledge and self-efficacy in applying IS in their own work. RESULTS: The study revealed a significant improvement in self-efficacy related to performing IS related tasks. Researchers reported heightened confidence in designing and implementing evidence-based interventions. In terms of perceived knowledge, participants retained what they learned at 4 months. The training fostered a collaborative learning environment, encouraging participants to exchange ideas and experiences. CONCLUSION: Targeted training in IS appears to enhance reproductive health researchers' capacity to translate research into practice, potentially leading to improved healthcare outcomes in Rwanda. Moving forward, we advocate for the Ministry of Health to establish structures for IS research agenda-setting, particularly for sexual and reproductive health and rights. Ideally, universities, health systems, and research institutions will incorporate IS capacity strengthening into their routine activities. Ongoing training is crucial to reinforce and expand IS knowledge. Our findings are expected to inform future interventions and guide policy development.

Exploring the content and delivery of feedback facilitation co-interventions: a systematic review.

BACKGROUND: Policymakers and researchers recommend supporting the capabilities of feedback recipients to increase the quality of care. There are different ways to support capabilities. We aimed to describe the content and delivery of feedback facilitation interventions delivered alongside audit and feedback within randomised controlled trials. METHODS: We included papers describing feedback facilitation identified by the latest Cochrane review of audit and feedback. The piloted extraction proforma was based upon a framework to describe intervention content, with additional prompts relating to the identification of influences, selection of improvement actions and consideration of priorities and implications. We describe the content and delivery graphically, statistically and narratively. RESULTS: We reviewed 146 papers describing 104 feedback facilitation interventions. Across included studies, feedback facilitation contained 26 different implementation strategies. There was a median of three implementation strategies per intervention and evidence that the number of strategies per intervention is increasing. Theory was used in 35 trials, although the precise role of theory was poorly described. Ten studies provided a logic model and six of these described their mechanisms of action. Both the exploration of influences and the selection of improvement actions were described in 46 of the feedback facilitation interventions; we describe who undertook this tailoring work. Exploring dose, there was large variation in duration (15-1800 min), frequency (1 to 42 times) and number of recipients per site (1 to 135). There were important gaps in reporting, but some evidence that reporting is improving over time. CONCLUSIONS: Heterogeneity in the design of feedback facilitation needs to be considered when assessing the intervention's effectiveness. We describe explicit feedback facilitation choices for future intervention developers based upon choices made to date. We found the Expert Recommendations for Implementing Change to be valuable when describing intervention components, with the potential for some minor clarifications in terms and for greater specificity by intervention providers. Reporting demonstrated extensive gaps which hinder both replication and learning. Feedback facilitation providers are recommended to close reporting gaps that hinder replication. Future work should seek to address the 'opportunity' for improvement activity, defined as factors that lie outside the individual that make care or improvement behaviour possible. REVIEW REGISTRATION: The study protocol was published at: https://www.protocols.io/private/4DA5DE33B68E11ED9EF70A58A9FEAC02 .

Leveraging systems science and design thinking to advance implementation science: moving toward a solution-oriented paradigm.

Many public health challenges are characterized by complexity that reflects the dynamic systems in which they occur. Such systems involve multiple interdependent factors, actors, and sectors that influence health, and are a primary driver of challenges of insufficient implementation, sustainment, and scale of evidence-based public health interventions. Implementation science frameworks have been developed to help embed evidence-based interventions in diverse settings and identify key factors that facilitate or hinder implementation. These frameworks are largely static in that they do not explain the nature and dynamics of interrelationships among the identified determinants, nor how those determinants might change over time. Furthermore, most implementation science frameworks are top-down, deterministic, and linear, leaving critical gaps in understanding of both how to intervene on determinants of successful implementation and how to scale evidence-based solutions. Design thinking and systems science offer methods for transforming this problem-oriented paradigm into one that is solution-oriented. This article describes these two approaches and how they can be integrated into implementation science strategies to promote implementation, sustainment, and scaling of public health innovation, ultimately resulting in transformative systems changes that improve population health.

Ultrasound in Cardiopulmonary Arrest and Resuscitation: Constructing Comprehensive Implementation Frameworks in High-Risk Settings.

OBJECTIVES: Information obtained from point-of-care ultrasound during cardiopulmonary arrest and resuscitation (POCUS-CA) can be used to identify underlying pathophysiology and provide life-sustaining interventions. However, integration of POCUS-CA into resuscitation care is inconsistent. We used expert consensus building methodology to help identify discrete barriers to clinical integration. We subsequently applied implementation science frameworks to generate generalizable strategies to overcome these barriers. MEASURES AND MAIN RESULTS: Two multidisciplinary expert working groups used KJ Reverse-Merlin consensus building method to identify and characterize barriers contributing to failed POCUS-CA utilization in a hypothetical future state. Identified barriers were organized into affinity groups. The Center for Implementation Research (CFIR) framework and Expert Recommendations for Implementing Change (CFIR-ERIC) tool were used to identify strategies to guide POCUS-US implementation. RESULTS: Sixteen multidisciplinary resuscitation content experts participated in the working groups and identified individual barriers, consolidated into 19 unique affinity groups that mapped 12 separate CFIR constructs, representing all 5 CFIR domains. The CFIR-ERIC tool identified the following strategies as most impactful to address barriers described in the affinity groups: identify and prepare champions, conduct local needs assessment, conduct local consensus discussions, and conduct educational meetings. CONCLUSIONS: KJ Reverse-Merlin consensus building identified multiple barriers to implementing POCUS-CA. Implementation science methodologies identified and prioritized strategies to overcome barriers and guide POCUS-CA implementation across diverse clinical settings.

Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya.

BACKGROUND: Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries. METHODS: This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years). DISCUSSION: This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries. TRIAL REGISTRATION: NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023.

A Narrative Review of NICU Implementation of Evidence-Based Early Relational Health Interventions.

BACKGROUND: Early relational health (ERH) interventions in the neonatal intensive care unit (NICU) buffer infants from toxic stress effects. Implementation science (IS) can guide successful uptake of evidence-based practice (EBP) ERH interventions. It is unknown if implementors of ERH interventions currently use the resources of IS to improve implementation. PURPOSE: A narrative review of recent literature on implementation of ERH EBPs was completed to understand (a) which ERH interventions are currently being implemented in NICUs globally, (b) whether clinical implementors of ERH interventions have adopted the resources of IS, (c) existence of implementation gaps, and (d) implementation outcomes of ERH interventions in contemporary literature. DATA SOURCES: Scopus, PubMed, and CINHAL were searched for original research regarding implementation of dyadic ERH interventions using key words related to IS and ERH. STUDY SELECTION: For inclusion, ERH EBPs had to have been implemented exclusively in NICU settings, contained data addressing an IS domain, printed in English within the last 5 years. Twenty-four studies met inclusion criteria. DATA EXTRACTION: Studies were distilled for intervention, IS domains addressed, location, aims, design, sample, and outcomes. RESULTS: Eleven ERH interventions were described in the literature. Few studies utilized the resources of IS, indicating variable degrees of success in implementation. Discussions of implementation cost were notably missing. IMPLICATIONS FOR PRACTICE AND RESEARCH: Implementors of ERH interventions appear to be largely unfamiliar with IS resources. More work is needed to reach clinicians with the tools and resources of IS to improve implementation outcomes.

Inter-organizational alignment and implementation outcomes in integrated mental healthcare for children and adolescents: a cross-sectional observational study.

BACKGROUND: Integrated care involves care provided by a team of professionals, often in non-traditional settings. A common example worldwide is integrated school-based mental health (SBMH), which involves externally employed clinicians providing care at schools. Integrated mental healthcare can improve the accessibility and efficiency of evidence-based practices (EBPs) for vulnerable populations suffering from fragmented traditional care. However, integration can complicate EBP implementation due to overlapping organizational contexts, diminishing the public health impact. Emerging literature suggests that EBP implementation may benefit from the similarities in the implementation context factors between the different organizations in integrated care, which we termed inter-organizational alignment (IOA). This study quantitatively explored whether and how IOA in general and implementation context factors are associated with implementation outcomes in integrated SBMH. METHODS: SBMH clinicians from community-based organizations (CBOs; nclinician = 27) and their proximal student-support school staff (nschool = 99) rated their schools and CBOs (clinician only) regarding general (organizational culture and molar climate) and implementation context factors (Implementation Climate and Leadership), and nine common implementation outcomes (e.g., treatment integrity, service access, acceptability). The levels of IOA were estimated by intra-class correlations (ICCs). We fitted multilevel models to estimate the standalone effects of context factors from CBOs and schools on implementation outcomes. We also estimated the 2-way interaction effects between CBO and school context factors (i.e., between-setting interdependence) on implementation outcomes. RESULTS: The IOA in general context factors exceeded those of implementation context factors. The standalone effects of implementation context factors on most implementation outcomes were larger than those of general context factors. Similarly, implementation context factors between CBOs and schools showed larger 2-way interaction effects on implementation outcomes than general context factors. CONCLUSIONS: This study preliminarily supported the importance of IOA in context factors for integrated SBMH. The findings shed light on how IOA in implementation and general context factors may be differentially associated with implementation outcomes across a broad array of integrated mental healthcare settings.

Pressure Injury Prevention in Adult Critically Ill Patients: A Best Practice Implementation Project.

Implementation science is the process of integrating an intervention into practice within an organization or health system and is a useful strategy to improve practice, affect patient outcomes, and promote practice sustainability. In this series, AJN and the journal JBI Evidence Implementation have partnered to deliver examples of how health care facilities from around the world have worked to solve common patient care problems. Through this partnership, we strive to create awareness and share knowledge and experiences by publishing summaries of studies that have appeared in JBI Evidence Implementation. These summaries are designed to provide nursing teams with an overview of the barriers faced and the strategies and resources needed to improve practice and drive change at the unit level. Our goal is to ensure that AJN readers have access to important evidence-based information designed to influence patient outcomes and nursing practice.-Carl A. Kirton, DNP, MBA, RN, ANP, FAAN.

The effect of audit and feedback and implementation support on guideline adherence and patient outcomes in cardiac rehabilitation: a study protocol for an open-label cluster-randomized effectiveness-implementation hybrid trial.

BACKGROUND: Providing secondary prevention through structured and comprehensive cardiac rehabilitation programmes to patients after a myocardial infarction (MI) reduces mortality and morbidity and improves health-related quality of life. Cardiac rehabilitation has the highest recommendation in current guidelines. While treatment target attainment rates at Swedish cardiac rehabilitation centres is among the highest in Europe, there are considerable differences in service delivery and variations in patient-level outcomes between centres. In this trial, we aim to study whether centre-level guideline adherence and patient-level outcomes across Swedish cardiac rehabilitation centres can be improved through a) regular audit and feedback of cardiac rehabilitation structure and processes through a national quality registry and b) supporting cardiac rehabilitation centres in implementing guidelines on secondary prevention. Furthermore, we aim to evaluate the implementation process and costs. METHODS: The study is an open-label cluster-randomized effectiveness-implementation hybrid trial including all 78 cardiac rehabilitation centres (attending to approximately 10 000 MI patients/year) that report to the SWEDEHEART registry. The centres will be randomized 1:1:1 to three clusters: 1) reporting cardiac rehabilitation structure and process variables to SWEDEHEART every six months (audit intervention) and being offered implementation support to implement guidelines on secondary prevention (implementation support intervention); 2) audit intervention only; or 3) no intervention offered. Baseline cardiac rehabilitation structure and process variables will be collected. The primary outcome is an adherence score measuring centre-level adherence to secondary prevention guidelines. Secondary outcomes include patient-level secondary prevention risk factor goal attainment at one-year after MI and major adverse coronary outcomes for up to five-years post-MI. Implementation outcomes include barriers and facilitators to guideline adherence evaluated using semi-structured focus-group interviews and relevant questionnaires, as well as costs and cost-effectiveness assessed by a comparative health economic evaluation. DISCUSSION: Optimizing cardiac rehabilitation centres' delivery of services to meet standards set in guidelines may lead to improvement in cardiovascular risk factors, including lifestyle factors, and ultimately a decrease in morbidity and mortality after MI. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT05889416 . Registered 2023-03-23.