Bridging the Gap between Intuition and Theory: A Comparison of Different Approaches to Implementation Strategy Development for Improving Lynch Syndrome Detection.

INTRODUCTION: Despite growing calls for the explicit application of theory when designing behaviour change interventions, limited empirical evidence exists regarding the effectiveness of these methods compared to non-theoretical approaches. A cluster randomized controlled trial (Hide and Seek Project - HaSP) tested two implementation approaches for improving hereditary cancer referral practices with one key distinction: implementation strategies were designed based explicitly on psychological theory or based on stakeholder intuition. This study presents the detailed methods and resources used to facilitate this comparison, whilst examining the strategies generated through both approaches. METHODS: Across seven Australian hospitals, clinical stakeholders attended focus groups to co-design site-specific strategies for improving Lynch syndrome referral. Co-design methods differed according to trial arm. Implementation strategy content was examined, with intuitively derived strategies retrospectively coded to determine theoretical alignment. RESULTS: Fifty-one strategies were proposed across all sites (theory-based arm = 32, intuition-based arm = 19). Overall, nine behaviour change technique (BCT) categories were used on 77 occasions. In the theory-based trial arm, eight BCT categories were identified on 53 occasions; and five BCT categories on 24 occasions in the intuition-based arm. BCT categories were largely similar across both arms. After retrospectively coding intuitively derived strategies, 42% contained mechanistic links, thereby demonstrating theoretical alignment. CONCLUSION: Methods facilitated robust comparison of theoretical and intuitive approaches to implementation strategy design. Recognizing the known benefits of theory for enhancing scientific learning, applying these methods on a larger scale may provide definitive evidence about the comparative effectiveness of theoretical approaches.

In person and virtual process mapping experiences to capture and explore variability in clinical practice: application to genetic referral pathways across seven Australian hospital networks.

Genetic referral for Lynch syndrome (LS) exemplifies complex clinical pathways. Identifying target behaviours (TBs) for change and associated barriers requires structured group consultation activities with busy clinicians - consolidating implementation activities whilst retaining rigour is crucial. This study aimed to: i) use process mapping to gain in-depth understandings of site-specific LS testing and referral practices in Australian hospitals and support identification of TBs for change, ii) explore if barriers to identified TBs could be identified through process mapping focus-group data, and iii) demonstrate pandemic-induced transition from in-person to virtual group interactive process mapping methods. LS clinical stakeholders attended interactive in-person or virtual focus groups to develop site-specific "process maps" visually representing referral pathways. Content analysis of transcriptions informed site-specific process maps, then clinical audit data was compared to highlight TBs for change. TBs were reviewed in follow-up focus groups. Secondary thematic analysis explored barriers to identified TBs, coded against the Theoretical Domains Framework (TDF). The transition from in-person to pandemic-induced virtual group interactive process mapping methods was documented. Process mapping highlighted six key areas of clinical practice variation across sites and site-specific TBs for change were identified. Key barriers to identified TBs emerged, categorised to seven TDF domains. Process mapping revealed variations in clinical practices surrounding LS referral between sites. Incorporating qualitative perspectives enhances process mapping by facilitating identification of TBs for change and barriers, providing a pathway to developing targeted interventions. Virtual process mapping activities produced detailed data and enabled comprehensive map development.

To achieve change in the health system using implementation approaches, time-poor clinicians must engage in information-gathering and idea-generation activities. This research revealed that qualitative process mapping focus groups held both in-person and virtually can be used to streamline these activities, by simultaneously identifying target behaviours for change, and barriers to change, while gaining information about site-specific clinical processes. Hospital process mapping shows that complex clinical processes vary significantly between sites, and that understanding local variation is crucial to developing targeted interventions. This study has informed new approaches to implementation research methods.

Lynch syndrome testing of colorectal cancer patients in a high-income country with universal healthcare: a retrospective study of current practice and gaps in seven australian hospitals.

BACKGROUND: To inform effective genomic medicine strategies, it is important to examine current approaches and gaps in well-established applications. Lynch syndrome (LS) causes 3-5% of colorectal cancers (CRCs). While guidelines commonly recommend LS tumour testing of all CRC patients, implementation in health systems is known to be highly variable. To provide insights on the heterogeneity in practice and current bottlenecks in a high-income country with universal healthcare, we characterise the approaches and gaps in LS testing and referral in seven Australian hospitals across three states. METHODS: We obtained surgery, pathology, and genetics services data for 1,624 patients who underwent CRC resections from 01/01/2017 to 31/12/2018 in the included hospitals. RESULTS: Tumour testing approaches differed between hospitals, with 0-19% of patients missing mismatch repair deficiency test results (total 211/1,624 patients). Tumour tests to exclude somatic MLH1 loss were incomplete at five hospitals (42/187 patients). Of 74 patients with tumour tests completed appropriately and indicating high risk of LS, 36 (49%) were missing a record of referral to genetics services for diagnostic testing, with higher missingness for older patients (0% of patients aged ≤ 40 years, 76% of patients aged > 70 years). Of 38 patients with high-risk tumour test results and genetics services referral, diagnostic testing was carried out for 25 (89%) and identified a LS pathogenic/likely pathogenic variant for 11 patients (44% of 25; 0.7% of 1,624 patients). CONCLUSIONS: Given the LS testing and referral gaps, further work is needed to identify strategies for successful integration of LS testing into clinical care, and provide a model for hereditary cancers and broader genomic medicine. Standardised reporting may help clinicians interpret tumour test results and initiate further actions.

What would I do? Perspectives on the factors underlying Lynch syndrome genetic testing and results sharing decisions for high-risk colorectal cancer patients.

OBJECTIVE: Universal tumour testing for Lynch syndrome (LS) in all incident colorectal cancers (CRCs) and sequential diagnostic genetic testing is cost-effective in Australia. Because of this, our study aimed to understand factors underlying possible decisions faced by tumour test-positive CRC patients and their at-risk relatives throughout the LS diagnosis pathway. METHODS: Semi-structured telephone interviews were conducted with 23 participants, using four hypothetical scenarios. Vignette-guided closed- and open-ended questions asked about LS genetic testing uptake, discussing diagnosis with at-risk relatives, and risk-reducing interventions. Personal perspectives on genetic testing were collected pre-post vignette discussion. Inductive thematic analysis was performed on open-ended questions. Decisional pathway diagrams were developed to convey factors influencing complex decision-making processes. RESULTS: Participant responses incorporated unfolding scenario information, resulting in three decision themes: (1) wanting to know one's LS status; (2) informing family about LS; (3) navigating risk-reducing interventions. Across all themes, 'knowledge' emerged as a facilitator, and 'negative emotional experience' as a barrier. Personal supportive views toward genetic testing increased post-interview. CONCLUSIONS: When communicating with tumour test-positive CRC patients or their relatives about LS genetic testing, providing guidance/resources to inform decisions around risk-reducing interventions and informing family members is critical. Scenario-driven interviews provide insight into what individuals might do when facing complex healthcare decisions and could aid informed decision-making. This approach may be applicable in other conditions, particularly with mainstreaming being increasingly introduced into the genetic context.

Building capacity from within: qualitative evaluation of a training program aimed at upskilling healthcare workers in delivering an evidence-based implementation approach.

Translating evidence into complex health systems is an ongoing challenge. Building the capacity of healthcare workers in behavioral and implementation science methods may facilitate the use of evidence-based implementation approaches, leading to sustainable and effective translation. The aim was to describe the development, contents and evaluation of a training workshop aimed at upskilling hospital-embedded staff to deliver an evidence-based implementation approach. The Hide and Seek Project (HaSP) is a cluster randomized controlled trial testing two implementation approaches for improving hereditary cancer referral at eight Australian hospitals. Healthcare workers were recruited as "Implementation Leads" and trained via a one-day workshop-TRAining in evideNce-baSed ImpLementATion for hEalth (TRANSLATE). The purpose of TRANSLATE was to upskill Implementation Leads in the delivery of HaSP, as well as implementation science methods more broadly. Implementation Leads participated in semi-structured evaluation interviews, which were analyzed using inductive thematic analysis. Nine Implementation Leads from various professional backgrounds completed the training. Four key themes were identified: (i) training day reactions, (ii) learning, (iii) implementation barriers and facilitators, and (iv) building health system capacity for implementation. Participants reported high levels of satisfaction, and anticipated that the knowledge and skills may be useful in the future. We describe a novel training program focused on the delivery of evidence-based implementation within health systems. Guided by insights from this study, methods to deliver the training on a larger scale and across different contexts are being explored. The prolonged impact of TRANSLATE will be further evaluated at trial completion. Trial registration: ANZCTR, ACTRN12618001072202. Registered on June 27, 2018.

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

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.