A Toolkit for Implementation of Clinical Genomic Testing: Using a Combined Stakeholder and Evidence-Driven Approach

Abstract

BACKGROUNDThe complexity of clinical genomics – testing your entire genetic information for health benefit – is a rapidly evolving field demanding swift clinical practice change at multiple levels as widespread testing in healthcare becomes a reality. We aimed to a) describe a combined stakeholder- and evidence-driven approach to developing a toolkit for implementing genomics into the Australian health system, and b) hypothesise key steps in the change to Theoretical Domains Framework (TDF) domains via coded implementation strategies and associated mechanistic links. METHODSThe TDF was used to analyse interview data from 16 nongenetic medical specialists using genomics in practice. Barriers and enablers were identified for three key target behaviour areas across the genomic testing process: 1) identifying patients, 2) test ordering/reporting, and 3) providing results. Barriers were grouped by distinct TDF domains, and, where barriers overlapped, ‘overarching’ domains were identified. Intuitive enabling strategies generated by clinicians were aligned with identified barriers, and retrospectively coded against evidence-based behaviour change techniques (BCTs). Additional theory-driven strategies were developed to address remaining identified barriers. Using structured expert consensus processes, members of the research team participated in a series of workshops to discuss and agree theory-informed links and propose mechanisms through which specific implementation strategies would address TDF-based barriers.RESULTSA total of 32 barriers were coded against TDF domains and constructs, and eight overarching TDF domains were identified on 13 occasions. Across all target behaviour areas, 21 BCTs were represented within the 30 intuitive enabling strategies generated by clinicians, found to be used on 49 occasions. Of these, nine (18%) aligned with a corresponding distinct TDF domain coded barrier that has previously demonstrated statistically significant mechanistic links. 20 new implementation strategies were developed to address nine remaining barriers using a theory-driven approach.CONCLUSIONThis study provides rich detail of crucial stages in intervention development, aiming to ensure implementation strategies are both evidence-informed and contextually appropriate. All barriers were mapped to the TDF, implementation strategies coded against BCTs, and standardised hypothesised behavioural pathways have been proposed, making potential underlying theory explicit. Next steps will be to test toolkit effectiveness for facilitating scale-up of genomics across Australia.