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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Colorectal Cancer | Study protocol

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

Authors: April Morrow, Emily Hogden, Yoon-Jung Kang, Julia Steinberg, Karen Canfell, Michael J. Solomon, James G. Kench, Anthony J. Gill, Tim Shaw, Nicholas Pachter, Bonny Parkinson, Luke Wolfenden, Gillian Mitchell, Finlay Macrae, Kathy Tucker, Natalie Taylor

Published in: Trials | Issue 1/2019

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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, ACTRN12618001072​202. Registered on 27 June 2018.
Appendix
Available only for authorised users
Footnotes
1
Policy1-Lynch comprises five model components, including a model of natural history of CRC in LS, model of screening for LS in incident CRC cases (i.e. identifying probands), model of screening for LS in family members (i.e. predictive genetic testing), model of prophylaxis and surveillance (prophylactic surgery, colonoscopic surveillance) and model of invasive cancer (cancer treatment and survival).
 
Literature
1.
Khoury MJ, Gwinn M, Yoon PW, Dowling N, Moore CA, Bradley L. The continuum of translation research in genomic medicine: how can we accelerate the appropriate integration of human genome discoveries into health care and disease prevention? Genet Med. 2007;9(10):665–74.PubMedCrossRef
2.
3.
Green RC, Berg JS, Grody WW, Kalia SS, Korf BR, Martin CL, et al. ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med. 2013;15(7):565.PubMedPubMedCentralCrossRef
4.
Manolio TA, Chisholm RL, Ozenberger B, Roden DM, Williams MS, Wilson R, et al. Implementing genomic medicine in the clinic: the future is here. Genet Med. 2013;15(4):258.PubMedPubMedCentralCrossRef
5.
Roberts MC, Kennedy AE, Chambers DA, Khoury MJ. The current state of implementation science in genomic medicine: opportunities for improvement. Genet Med. 2017;19(8):858–63.PubMedPubMedCentralCrossRef
6.
George A, Riddell D, Seal S, Talukdar S, Mahamdallie S, Ruark E, et al. Implementing rapid, robust, cost-effective, patient-centred, routine genetic testing in ovarian cancer patients. Sci Rep. 2016;6:29506.PubMedPubMedCentralCrossRef
7.
8.
Hampel H, Sweet K, Westman JA, Offit K, Eng C. Referral for cancer genetics consultation: a review and compilation of risk assessment criteria. J Med Genet. 2004;41(2):81–91.PubMedPubMedCentralCrossRef
9.
Kentwell M, Dow E, Antill Y, Wrede CD, McNally O, Higgs E, et al. Mainstreaming cancer genetics: a model integrating germline BRCA testing into routine ovarian cancer clinics. Gynecol Oncol. 2017;145(1):130–6.PubMedCrossRef
10.
Weren RD, Mensenkamp AR, Simons M, Eijkelenboom A, Sie AS, Ouchene H, et al. Novel BRCA1 and BRCA2 tumor test as basis for treatment decisions and referral for genetic counselling of patients with ovarian carcinomas. Hum Mutat. 2017;38(2):226–35.PubMedCrossRef
11.
Brennan B, Hemmings CT, Clark I, Yip D, Fadia M, Taupin DR. Universal molecular screening does not effectively detect Lynch syndrome in clinical practice. Ther Adv Gastroenterol. 2017;10(4):361–71.CrossRef
12.
Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, et al. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015;10(1):21.PubMedPubMedCentralCrossRef
13.
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4(1):50.PubMedPubMedCentralCrossRef
14.
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–7.PubMedPubMedCentralCrossRef
15.
16.
Taylor N, Lawton R, Slater B, Foy R. The demonstration of a theory-based approach to the design of localized patient safety interventions. Implement Sci. 2013;8(1):123.PubMedPubMedCentralCrossRef
17.
Hrisos S, Eccles M, Johnston M, Francis J, Kaner EF, Steen N, et al. An intervention modelling experiment to change GPs' intentions to implement evidence-based practice: using theory-based interventions to promote GP management of upper respiratory tract infection without prescribing antibiotics #2. BMC Health Serv Res. 2008;8(1):10.PubMedPubMedCentralCrossRef
18.
19.
Cane J, O’Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012;7(1):37.PubMedPubMedCentralCrossRef
20.
McKenzie JE, O'Connor DA, Page MJ, Mortimer DS, French SD, Walker BF, et al. Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial): a cluster randomised trial protocol. Implement Sci. 2010;5(1):86.PubMedPubMedCentralCrossRef
21.
Tavender EJ, Bosch M, Gruen RL, Green SE, Michie S, Brennan SE, et al. Developing a targeted, theory-informed implementation intervention using two theoretical frameworks to address health professional and organisational factors: a case study to improve the management of mild traumatic brain injury in the emergency department. Implement Sci. 2015;10(1):74.PubMedPubMedCentralCrossRef
22.
Backman R, Foy R, Michael BD, Defres S, Kneen R, Solomon T. The development of an intervention to promote adherence to national guidelines for suspected viral encephalitis. Implement Sci. 2015;10(1):37.PubMedPubMedCentralCrossRef
23.
Möhler R, Köpke S, Meyer G. Criteria for reporting the development and evaluation of complex interventions in healthcare: revised guideline (CReDECI 2). Trials. 2015;16(1):204.PubMedPubMedCentralCrossRef
24.
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258.PubMedPubMedCentralCrossRef
25.
Harvey G, Kitson A. Translating evidence into healthcare policy and practice: single versus multi-faceted implementation strategies–is there a simple answer to a complex question? Int J Health Policy Manag. 2015;4(3):123.PubMedPubMedCentralCrossRef
26.
Møller P, Seppälä TT, Bernstein I, Holinski-Feder E, Sala P, Evans DG, et al. Cancer risk and survival in path_MMR carriers by gene and gender up to 75 years of age: a report from the Prospective Lynch Syndrome Database. Gut. 2018;67(7):1306–16.PubMedCrossRef
27.
Schmeler KM, Lynch HT, L-m C, Munsell MF, Soliman PT, Clark MB, et al. Prophylactic surgery to reduce the risk of gynecologic cancers in the Lynch syndrome. N Engl J Med. 2006;354(3):261–9.PubMedCrossRef
28.
Barrow P, Khan M, Lalloo F, Evans D, Hill J. Systematic review of the impact of registration and screening on colorectal cancer incidence and mortality in familial adenomatous polyposis and Lynch syndrome. Br J Surg. 2013;100(13):1719–31.PubMedCrossRef
29.
Wong C, Gibbs P, Johns J, Jones I, Faragher I, Lynch E, et al. Value of database linkage: are patients at risk of familial colorectal cancer being referred for genetic counselling and testing? Intern Med J. 2008;38(5):328–33.PubMedCrossRef
30.
Long JC, Debono D, Williams R, Salisbury E, O'Neill S, Eykman E, et al. Using behaviour change and implementation science to address low referral rates in oncology. BMC Health Serv Res. 2018;18(1):904.
31.
Leistikow IP, Kalkman CJ, de Bruijn H. Why patient safety is such a tough nut to crack. BMJ. 2011;342:d3447.PubMedCrossRef
32.
33.
Eccles M, Grimshaw J, Walker A, Johnston M, Pitts N. Changing the behavior of healthcare professionals: the use of theory in promoting the uptake of research findings. J Clin Epidemiol. 2005;58(2):107–12.PubMedCrossRef
34.
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Br Med J. 2013;346:e7586.PubMedPubMedCentralCrossRef
35.
Grant S, Mayo-Wilson E, Montgomery P, Macdonald G, Michie S, Hopewell S, et al. CONSORT-SPI 2018 explanation and elaboration: guidance for reporting social and psychological intervention trials. Trials. 2018;19(1):406.PubMedPubMedCentralCrossRef
36.
Long JC, Winata T, Debono D, Phan-Thien K-C, Zhu C, Taylor N. Process evaluation of a behaviour change approach to improving clinical practice for detecting hereditary cancer. BMC Health Serv Res. 2019;19(1):180.PubMedPubMedCentralCrossRef
37.
Taylor N, Parveen S, Robins V, Slater B, Lawton R. Development and initial validation of the Influences on Patient Safety Behaviours Questionnaire. Implement Sci. 2013;8(1):81.PubMedPubMedCentralCrossRef
38.
Michie S, Atkins L, West R. The behaviour change wheel: a guide to designing interventions. 1st ed. London: Silverback Publishing; 2014.
39.
Gonzales R, Handley MA, Ackerman S, O'Sullivan PS. A framework for training health professionals in implementation and dissemination science. Acad Med. 2012;87(3):271–8.PubMedPubMedCentral
40.
Atkins L, Francis J, Islam R, O’Connor D, Patey A, Ivers N, et al. A guide to using the theoretical domains framework of behaviour change to investigate implementation problems. Implement Sci. 2017;12(1):77.PubMedPubMedCentralCrossRef
41.
McCormack B, Rycroft-Malone J, DeCorby K, Hutchinson AM, Bucknall T, Kent B, et al. A realist review of interventions and strategies to promote evidence-informed healthcare: a focus on change agency. Implement Sci. 2013;8(1):107.PubMedPubMedCentralCrossRef
42.
Michie S, Atkins L, West R. The behaviour change wheel : a guide to designing interventions. UK: Silverback; 2014.
43.
Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, et al. Standards for Reporting Implementation Studies (StaRI) Statement. BMJ. 2017;356:i6795.PubMedPubMedCentralCrossRef
44.
Rodda S, Merkouris SS, Abraham C, Hodgins DC, Cowlishaw S, Dowling NA. Therapist-delivered and self-help interventions for gambling problems: A review of contents. J Behav Addict. 2018;7(2):1–16.PubMedPubMedCentralCrossRef
45.
Abraham C. Charting variability to ensure conceptual and design precision: a comment on Ogden (2016). Health Psychol Rev. 2016;10(3):260–4.PubMedCrossRef
46.
Leyrat C, Morgan KE, Leurent B, Kahan BC. Cluster randomized trials with a small number of clusters: which analyses should be used? Int J Epidemiol. 2017;47(1):321–31.CrossRef
47.
Lew J-B, Simms KT, Smith MA, Hall M, Kang Y-J, Xu XM, et al. Primary HPV testing versus cytology-based cervical screening in women in Australia vaccinated for HPV and unvaccinated: effectiveness and economic assessment for the National Cervical Screening Program. Lancet Public Health. 2017;2(2):e96–e107.PubMedCrossRef
48.
Lew J-B, St John DJB, Xu X-M, Greuter MJE, Caruana M, Cenin DR, et al. Long-term evaluation of benefits, harms, and cost-effectiveness of the National Bowel Cancer Screening Program in Australia: a modelling study. Lancet Public Health. 2017;2(7):e331–e40.PubMedCrossRef
49.
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81–95.PubMedCrossRef
Metadata
Title
Comparing theory and non-theory based implementation approaches to improving referral practices in cancer genetics: a cluster randomised trial protocol
Authors
April Morrow
Emily Hogden
Yoon-Jung Kang
Julia Steinberg
Karen Canfell
Michael J. Solomon
James G. Kench
Anthony J. Gill
Tim Shaw
Nicholas Pachter
Bonny Parkinson
Luke Wolfenden
Gillian Mitchell
Finlay Macrae
Kathy Tucker
Natalie Taylor
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3457-6

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