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

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

Aligning intuition and theory: enhancing the replicability of behaviour change interventions in cancer genetics

“…Some have since applied implementation science and/or behaviour change theory principles to their clinical and research practices (e.g. [24,25]).…”

“…Second, we were unable to formally evaluate if and how the intervention strategies would differ if theory were to be used prospectively. However, further work is underway in the context of hereditary cancer clinical practice to directly test and explore the differences in effects of intuitively and theory informed approaches to intervention design [24,25].…”

The health and economic impact of implementation strategies for improving detection of hereditary cancer patients—protocol for an in-depth cost-effectiveness evaluation with microsimulation modelling

“…The analysis will combine clinical trial outcomes (changes in Lynch syndrome tumour testing and referral practices) and cost data. Measures for cost collection have been incorporated into an in-depth process evaluation conducted simultaneously alongside the HaSP trial [27]. Analysis will be performed in three stages: a HaSP cost analysis (stage 1), incorporation of HaSP costs into a microsimulation model (stage 2) and a cost-effectiveness evaluation (stage 3).…”

“…the approach resulting in greater improvement in Lynch syndrome referral), there is a further need to assess their comparative costs. A mixed-methods, theory-driven process evaluation is being undertaken in parallel to the HaSP trial in each of the hospital networks [27]. Guided by the UK Medical Research Council guidance statement on process evaluations [28], qualitative and quantitative data will be obtained from various sources throughout each of the HaSP phases (e.g.…”

“…Aligning with new recommendations in the implementation science literature, findings from the economic evaluation will be interpreted alongside contextual information and stakeholder perspectives obtained from the qualitative process evaluation data [29]. Full details of the qualitative measures and analysis plan are available elsewhere [27]. Methods for collecting and evaluating cost data have been incorporated in the process evaluation and are summarised below and in Fig.…”