Comparing theory and non-theory based implementation approaches to improving referral practices in cancer genetics: a cluster randomised trial protocol

Abstract

Background Lynch syndrome (LS) is an inherited, cancer predisposition syndrome associated with an increased risk of colorectal, endometrial and other cancer types. Identifying individuals with LS allows access to cancer risk management strategies proven to reduce cancer incidence and improve survival. However, LS is underdiagnosed and genetic referral rates are poor. Improving LS referral is complex, and requires multisystem behaviour change. Although barriers have been identified, evidence-based strategies to facilitate behaviour change are lacking. The aim of this study is to compare the effectiveness of a theory-based implementation approach against a non-theory based approach for improving detection of LS amongst Australian patients with colorectal cancer (CRC). Methods A two-arm parallel cluster randomised trial design will be used to compare two identical, structured implementation approaches, distinguished only by the use of theory to identify barriers and design targeted intervention strategies, to improve LS referral practices in eight large Australian hospital networks. Each hospital network will be randomly allocated to a trial arm, with stratification by state. A trained healthcare professional will lead the following phases at each site: (1) undertake baseline clinical practice audits, (2) form multidisciplinary Implementation Teams, (3) identify target behaviours for practice change, (4) identify barriers to change, (5) generate intervention strategies, (6) support staff to implement interventions and (7) evaluate the effectiveness of the intervention using post-implementation clinical data. The theoretical and non-theoretical components of each trial arm will be distinguished in phases 4–5. Study outcomes include a LS referral process map for each hospital network, with evaluation of the proportion of patients with risk-appropriate completion of the LS referral pathway within 2 months of CRC resection pre and post implementation. Discussion This trial will determine the more effective approach for improving the detection of LS amongst patients with CRC, whilst also advancing understanding of the impact of theory-based implementation approaches in complex health systems and the feasibility of training healthcare professionals to use them. Insights gained will guide the development of future interventions to improve LS identification on a larger scale and across different contexts, as well as efforts to address the gap between evidence and practice in the rapidly evolving field of genomic research. Trial registration ANZCTR, ACTRN12618001072202 . Registered on 27 June 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3457-6) contains supplementary material, which is available to authorized users.

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].…”

Pathways to a cancer-free future: a protocol for modelled evaluations to minimise the future burden of colorectal cancer in Australia

“…The next step, implementation of interventions and policies into practice, is crucial for ensuring the benefits of optimal approaches are realised by the Australian population, and has begun for patients with Lynch syndrome. 18 Evidencebased approaches to inform 'best buys' in policy reform, accounting for context, system complexity and stakeholder perspectives, are a fundamental prerequisite for successful and sustained translation of discoveries into real-world settings. The Pathways programme presents the opportunity to continually optimise evidence-based support for cancer control interventions.…”

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

“…A detailed protocol for the HaSP trial is available elsewhere. 15 Briefly, a cluster RCT will be used to test a theoretically driven structured implementation approach against a structured implementation approach (without the explicit use of theory) for improving LS referral practices for CRC patients in eight large Australian hospital networks. At each hospital network, a locally employed healthcare professional (eg, nurse, genetic counsellor) will be appointed and trained as an 'Implementation Lead' to coordinate the implementation approach, with ongoing support from researchers with expertise in implementation science and behavioural change.…”

“…[12][13][14] Undertaking an in-depth process evaluation alongside an intervention trial can provide a more detailed picture of contextual influences and complex causal processes, thereby helping policy-makers, clinicians and researchers interpret trial findings and understand how they might be applied elsewhere. 14 The Hide and Seek Project (HaSP): Improving detection of patients with colorectal cancer (CRC) with a high risk of Lynch syndrome (LS) 15 is a cluster RCT that will assess the effectiveness of two different implementation approaches aimed at improving detection of LS among patients with CRC, and is the focus of this in-depth process evaluation. LS is a hereditary cancer predisposition conferring an increased lifetime risk of colorectal, endometrial, ovarian and other cancer types.…”