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A transformative translational change programme to introduce genomics into healthcare: a complexity and implementation science study protocol
  1. Natalie Taylor1,2,3,
  2. Stephanie Best2,4,
  3. Melissa Martyn5,6,7,
  4. Janet C Long2,
  5. Kathryn N North4,6,
  6. Jeffrey Braithwaite2,4,
  7. Clara Gaff5,7
  1. 1 Cancer Council New South Wales, Woolloomooloo, New South Wales, Australia
  2. 2 Centre for Healthcare Resilience and Implementation Science, Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia
  3. 3 Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia
  4. 4 Australian Genomics, Murdoch Children’s Research Institute, Parkville, Victoria, Australia
  5. 5 Melbourne Genomics Health Alliance, Walter and Eliza Hall Institute, Melbourne, Victoria, Australia
  6. 6 Murdoch Children’s Research Institute, Royal Children’s Hospital, Parkville, Victoria, Australia
  7. 7 Department of Paediatrics and Medicine, University of Melbourne, Melbourne, UK
  1. Correspondence to Dr Natalie Taylor; natalie.taylor{at}nswcc.org.au

Abstract

Introduction Translating scientific advances in genomic medicine into evidence-based clinical practice is challenging. Studying the natural translation of genomics into ‘early-adopting’ health system sectors is essential. We will (a) examine 29 health systems (Australian and Melbourne Genomics Health Alliance flagships) integrating genomics into practice and (b) combine this learning to co-design and test an evidence-based generalisable toolkit for translating genomics into healthcare.

Methods and analysis Twenty-nine flagships integrating genomics into clinical settings are studied as complex adaptive systems to understand emergent and self-organising behaviours among inter-related actors and processes. The Effectiveness–Implementation Hybrid approach is applied to gather information on the delivery and potential for real-world implementation. Stages ‘1’ and ‘2a’ (representing hybrid model 1) are the focus of this protocol. The Translation Science to Population Impact (TSci Impact) framework is used to study policy decisions and service provision, and the Theoretical Domains Framework (TDF) is used to understand individual level behavioural change; both frameworks are applied across stages 1 and 2a. Stage 1 synthesises interview data from 32 participants involved in developing the genomics clinical practice systems and approaches across five ‘demonstration-phase’ (early adopter) flagships. In stage 2a, stakeholders are providing quantitative and qualitative data on process mapping, clinical audits, uptake and sustainability (TSci Impact), and psychosocial and environmental determinants of change (TDF). Findings will be synthesised before codesigning an intervention toolkit to facilitate implementation of genomic testing. Study methods to simultaneously test the comparative effectiveness of genomic testing and the implementation toolkit (stage 2b), and the refined implementation toolkit while simply observing the genomics intervention (stage 3) are summarised.

Ethics and dissemination Ethical approval has been granted. The results will be disseminated in academic forums and used to refine interventions to translate genomics evidence into healthcare. Non-traditional academic dissemination methods (eg, change in guidelines or government policy) will also be employed.

  • genomics
  • complexity
  • implementation
  • behaviour change
  • sustainability
  • translation

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors NT conceived, designed and developed the detail of the study, provided advice for ethical approval, led and coordinated writing the paper. SB developed the detail of the study design, co-led the ethical approval and co-led writing the paper. MM conceived and co-designed the study details, led the ethical approval process and reviewed the paper. JCL co-designed the study details, provided advice for ethical approval and reviewed the paper. KNN is the Chief Investigator for the Australian Genomics Health Alliance NHMRC grant; she contributed to conception of the study, provided strategic input and reviewed the paper. JB contributed to conception of the study, provided advice, strategic input and expertise in implementation and complexity science, and reviewed the paper. CG conceived and co-designed the study, provided advice, strategic input and reviewed the paper. All authors read and approved the final manuscript. KNN, CG and JB are chief investigators on the National Health and Medical Research Council grant funding the Australian Genomics Health Alliance.

  • Funding The Melbourne Genomics Health Alliance is funded by the Victorian Government and Alliance 10 members (Royal Melbourne Hospital, Royal Children’s Hospital, the University of Melbourne, Walter and Eliza Hall Institute, Murdoch Children’s Research Institute, Commonwealth Scientific and Industrial Research Organisation, Australian Genome Research Facility, Peter MacCallum Cancer Centre, Austin Health, Monash Health). The Australian Genomics Health Alliance is funded by NHMRC grant 1113531.

  • Competing interests None declared.

  • Ethics approval Melbourne Health HREC.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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