Dataset Information

Understanding implementation success: protocol for an in-depth, mixed-methods process evaluation of a cluster randomised controlled trial testing methods to improve detection of Lynch syndrome in Australian hospitals.

ABSTRACT:

Introduction

In multisite intervention trials, implementation success often varies widely across settings. Process evaluations are crucial to interpreting trial outcomes and understanding contextual factors and causal chains necessary for successful implementation. Lynch syndrome is a hereditary cancer predisposition conferring an increased risk of colorectal, endometrial and other cancer types. Despite systematic screening protocols to identify Lynch syndrome, the condition remains largely underdiagnosed. The Hide and Seek Project ('HaSP') is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks. To enhance widespread implementation of optimal Lynch syndrome identification, there is a need to understand not only what works, but also why, in what contexts, and at what costs. Here we describe an in-depth investigation of factors influencing successful implementation of procedures evaluated in the HaSP trial.

Methods and analysis

A mixed-methods, theory-driven process evaluation will be undertaken in parallel to the HaSP trial. Data will include: interviews of Implementation Leads and Lynch syndrome stakeholders, pre-post implementation questionnaires, audio analysis of meetings and focus groups, observation of multidisciplinary team meetings, fidelity checklists and project log analysis. Results will be triangulated and coded, drawing on the Theoretical Domains Framework, Consolidated Framework for Implementation Research and Proctor's implementation outcomes.

Ethics and dissemination

Use of a theory-based process evaluation will enhance interpretation and generalisability of HaSP trial findings, and contribute to the implementation research field by furthering understanding of the conditions necessary for implementation success. Ethical approval has been granted and results will be disseminated via publications in peer-reviewed journals and conference presentations. At trial completion, key findings will be fed back to sites to enable refinement of intervention strategies, both in the context of Lynch syndrome and for the possible generalisability of intervention components in other genetic and broader clinical specialties.

Hasp trial registration number

Australian New Zealand Clinical Trials Registry (Identifier: ACTRN12618001072202). Registered 27 June 2018. http://www.ANZCTR.org.au/ACTRN12618001072202.aspx.

SUBMITTER: Morrow A

PROVIDER: S-EPMC7299044 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Understanding implementation success: protocol for an in-depth, mixed-methods process evaluation of a cluster randomised controlled trial testing methods to improve detection of Lynch syndrome in Australian hospitals.

Morrow April A Tucker Katherine M KM Shaw Tim J TJ Parkinson Bonny B Abraham Charles C Wolfenden Luke L Taylor Natalie N

BMJ open 20200615 6

<h4>Introduction</h4>In multisite intervention trials, implementation success often varies widely across settings. Process evaluations are crucial to interpreting trial outcomes and understanding contextual factors and causal chains necessary for successful implementation. Lynch syndrome is a hereditary cancer predisposition conferring an increased risk of colorectal, endometrial and other cancer types. Despite systematic screening protocols to identify Lynch syndrome, the condition remains larg ...[more]

PMID: 32540886

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Project description:BackgroundTrial method research produces recommendations on how to best conduct trials. However, findings are not routinely implemented into practice. To better understand why, we conducted a mixed method study on the challenges of implementing trial method research findings into UK-based clinical trial units.MethodsThree stages of research were conducted. Firstly, case studies of completed projects that provided methodological recommendations were identified within trial design, conduct, analysis, and reporting. These case studies were used as survey examples to query obstacles and facilitators to implementing method research. Survey participants were experienced trial staff, identified via email invitations to UK clinical trial units. This survey assessed the case studies' rates of implementation, and demographic characteristics of trial units through the Consolidated Framework for Implementation Research. Further, interviews were conducted with senior members of trial units to explore obstacles and facilitators in more detail. Participants were sampled from trial units that indicated their willingness to participate in interviews following the survey. Interviews, and analysis, were structured via the Capability, Opportunity, Motivation Model of Behaviour. Finally, potential strategies to leverage lessons learned were generated via the Behaviour Change Wheel.ResultsA total of 27 UK trial units responded to the survey. The rates of implementation across the case studies varied, with most trial units implementing recommendations in trial conduct and only few implementing recommendations in reporting. However, most reported implementing recommendations was important but that they lacked the resources to do so. A total of 16 senior members of trial units were interviewed. Several themes were generated from interviews and fell broadly into categories related to the methods recommendations themselves, the trial units, or external factors affecting implementation. Belief statements within themes indicated resources issues and awareness of recommendations as frequent implementation obstacles. Participation in trial networks and recommendations packaged with relevant resources were cited frequently as implementation facilitators. These obstacles and facilitators mirrored results from the survey. Results were mapped, via the Behaviour Change Wheel, to intervention functions likely to change behaviours of obstacles and facilitators identified. These intervention functions were developed into potential solutions to reduce obstacles and enhance facilitators to implementation.ConclusionsSeveral key areas affecting implementation of trial method recommendations were identified. Potential methods to enhance facilitators and reduce obstacles are suggested. Future research is needed to refine these methods and assess their feasibility and acceptability.

Project description:By 2030, 80 % of the annual 8.3 million deaths attributable to tobacco will be in low-income countries (LICs). Yet, services to support people to quit tobacco are not part of routine primary care in LICs. This study explored the challenges to implementing a behavioural support (BS) intervention to promote tobacco cessation within primary care in Nepal.The study used qualitative and quantitative methods within an action research approach in three primary health care centres (PHCCs) in two districts of Nepal. Before implementation, 21 patient interviews and two focus groups with health workers informed intervention design. Over a 6-month period, two researchers facilitated action research meetings with staff and observed implementation, recording the process and their reflections in diaries. Patients were followed up 3 months after BS to determine tobacco use (verified biochemically) and gain feedback on the intervention. A further five interviews with managers provided reflections on the process. The qualitative analysis used Normalisation Process Theory (NPT) to understand implementation.Only 2 % of out-patient appointments identified the patient as a smoker. Qualitative findings highlight patients' unwillingness to admit their smoking status and limited motivation among health workers to offer the intervention. Patient-centred skills needed for BS were new to staff, who found them challenging particularly with low-literacy patients (skill set workability). Heath workers saw cessation advice and BS as an addition to their existing workload (relational integration). While there was strong policy buy-in, operationalising this through reporting and supervision was limited (contextual integration). Of the 44 patients receiving the intervention, 27 were successfully followed up after 3 months; 37 % of these had quit (verified biochemically).Traditionally, primary health care in LICs has focused on acute care; with increasing recognition of the need for lifestyle change, health workers must develop new skills and relationships with patients. Appropriate and regular recording, reporting, supervision and clear leadership are needed if health workers are to take responsibility for smoking cessation. The consistent implementation of these health system activities is a requirement if cessation services are to be normalised within routine primary care.

Project description:BackgroundTraditional discharge processes lack a patient-centred focus. This project studied the implementation and effectiveness of an individualized discharge tool across Ontario hospitals. The Patient Oriented Discharge Summary (PODS) is an individualized discharge tool with guidelines that was co-designed with patients and families to enable a patient-centred process.MethodsTwenty one acute-care and rehabilitation hospitals in Ontario, Canada engaged in a community of practice and worked over a period of 18 months to implement PODS. An effectiveness-implementation hybrid design using a triangulation approach was used with hospital-collected data, patient and provider surveys, and interviews of project teams. Key outcomes included: penetration and fidelity of the intervention, change in patient-centred processes, patient and provider satisfaction and experience, and healthcare utilization. Statistical methods included linear mixed effects models and generalized estimating equations.ResultsOf 65,221 discharges across hospitals, 41,884 patients (64%) received a PODS. There was variation in reach and implementation pattern between sites, though none of the between site covariates was significantly associated with implementation success. Both high participation in the community of practice and high fidelity were associated with higher penetration. PODS improved family involvement during discharge teaching (7% increase, p = 0.026), use of teach-back (11% increase, p < 0.001) and discussion of help needed (6% increase, p = 0.041). Although unscheduled healthcare utilization decreased with PODS implementation, it was not statistically significant.ConclusionsThis project highlighted the system-wide adaptability and ease of implementing PODS across multiple patient groups and hospital settings. PODS demonstrated an improvement in patient-centred discharge processes linked to quality standards and health outcomes. A community of practice and high quality content may be needed for successful implementation.

Project description:BackgroundAn on-site pharmacist (OSP) intervention was implemented which sought to improve medication management within residential aged care facilities (RACFs) in the Australian Capital Territory, Australia. The objectives of this mixed methods study were to evaluate the implementation fidelity of the OSP intervention and to determine the moderating factors which influenced delivery of this intervention.MethodsThis convergent parallel mixed methods study was underpinned by Hasson's conceptual framework for implementation fidelity. Implementation fidelity for seven intervention RACFs was quantitatively assessed using three quantitative data sets: (1) range of OSP intervention activities delivered; (2) random sample of 10% of medication reviews assessed for quality; (3) proportion of residents who received at least one medication review. Semi-structured interviews (n = 14) with managers and OSPs across the intervention RACFs were conducted to identify moderating factors which may have influenced OSP intervention delivery.ResultsThe OSP intervention was generally delivered as intended with overall medium levels of implementation fidelity. This delivery was supported by a range of facilitation strategies with most participants perceiving that the intervention was delivered to a high standard. RACF managers and OSPs were mostly well engaged and responsive. A number of potential barriers (including the part-time OSP role, COVID-19 pandemic, RACFs spread out over a large area with significant distance between resident dwellings) and facilitators (including the pharmacist support meetings, OSPs who took time to establish relationships, RACF managers who actively supported OSPs and worked with them) for OSP intervention delivery were identified which have potential implications for the roll out of OSPs within Australian RACFs.ConclusionIn this study, the implementation fidelity of OSP intervention delivery was assessed with overall medium levels of fidelity found across the intervention RACFs. This suggested that the OSP intervention can generally be delivered as intended in real world RACFs. OSP intervention delivery was influenced by a range of moderating factors, some of which posed barriers and others which facilitated the OSP intervention being delivered as intended.

Project description:BACKGROUND:The Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is one of the first large pragmatic randomized clinical trials (pRCTs) to be conducted in U.S. nursing homes (N = 119 intervention and N = 241 control across two health-care systems). The trial aims to evaluate the effectiveness of a suite of videos to improve advance care planning (ACP) for nursing home patients. This report uses mixed methods to explore the optimal and suboptimal conditions necessary for implementation fidelity within pRCTs in nursing homes. METHODS:PROVEN's protocol required designated facility champions to offer an ACP video to long-stay patients every 6 months during the 18-month implementation period. Champions completed a video status report, stored within electronic medical records, each time a video was offered. Data from the report were used to derive each facility's adherence rate (i.e., cumulative video offer). Qualitative interviews held after 15 months with champions were purposively sampled from facilities within the highest and lowest adherence rates (i.e., those in the top and bottom quintiles). Two researchers analyzed interview data thematically using a deductive approach based upon six domains of the revised Conceptual Framework for Implementation Fidelity (CFIF). Matrices were developed to compare coded narratives by domain across facility adherence status. RESULTS:In total, 28 interviews involving 33 champions were analyzed. Different patterns were observed across high- versus low-adherence facilities for five CFIF domains. In low-adherence nursing homes, (1) there were limited implementation resources (Context), (2) there was often a perceived negative patient or family responsiveness to the program (Participant Responsiveness), and (3) champions were reticent in offering the videos (Recruitment). In high-adherence nursing homes, (1) there was more perceived patient and family willingness to engage in the program (Participant Responsiveness), (2) champions supplemented the video with ACP conversations (Quality of Delivery), (3) there were strategic approaches to recruitment (Recruitment), and (4) champions appreciated external facilitation (Strategies to Facilitate Implementation). CONCLUSIONS:Critical lessons for implementing pRCTs in nursing homes emerged from this report: (1) flexible fidelity is important (i.e., delivering core elements of an intervention while permitting the adaptation of non-core elements), (2) reciprocal facilitation is vital (i.e., early and ongoing stakeholder engagement in research design and, reciprocally, researchers' and organizational leaders' ongoing support of the implementation), and (3) organizational and champion readiness should be formally assessed early and throughout implementation to facilitate remediation. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02612688. Registered on 19 November 2015.

Project description:BackgroundRelapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility.ObjectiveThis study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report.MethodsThe overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies.ResultsThe results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019.ConclusionsThe findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial.Trial registrationISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262.International registered report identifier (irrid)DERR1-10.2196/15634.

Dataset Information

Understanding implementation success: protocol for an in-depth, mixed-methods process evaluation of a cluster randomised controlled trial testing methods to improve detection of Lynch syndrome in Australian hospitals.

Introduction

Methods and analysis

Ethics and dissemination

Hasp trial registration number

Publications

Understanding implementation success: protocol for an in-depth, mixed-methods process evaluation of a cluster randomised controlled trial testing methods to improve detection of Lynch syndrome in Australian hospitals.

Similar Datasets

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