Comparison of implementation strategies to influence adherence to the clinical pathway for screening, assessment and management of anxiety and depression in adult cancer patients (ADAPT CP): study protocol of a cluster randomised controlled trial

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Abstract

Background

Health service change is difficult to achieve. One strategy to facilitate such change is the clinical pathway, a guide for clinicians containing a defined set of evidence-based interventions for a specific condition. However, optimal strategies for implementing clinical pathways are not well understood. Building on a strong evidence-base, the Psycho-Oncology Co-operative Research Group (PoCoG) in Australia developed an evidence and consensus-based clinical pathway for screening, assessing and managing cancer-related anxiety and depression (ADAPT CP) and web-based resources to support it - staff training, patient education, cognitive-behavioural therapy and a management system (ADAPT Portal). The ADAPT Portal manages patient screening and prompts staff to follow the recommendations of the ADAPT CP. This study compares the clinical and cost effectiveness of two implementation strategies (varying in resource intensiveness), designed to encourage adherence to the ADAPT CP over a 12-month period.

Methods

This cluster randomised controlled trial will recruit 12 cancer service sites, stratified by size (large versus small), and randomised at site level to a standard (Core) versus supported (Enhanced) implementation strategy. After a 3-month period of site engagement, staff training and site tailoring of the ADAPT CP and Portal, each site will “Go-live”, implementing the ADAPT CP for 12 months. During the implementation phase, all eligible patients will be introduced to the ADAPT CP as routine care. Patient participants will be registered on the ADAPT Portal to complete screening for anxiety and depression. Staff will be responsible for responding to prompts to follow the ADAPT CP. The primary outcome will be adherence to the ADAPT CP. Secondary outcomes include staff attitudes to and experiences of following the ADAPT CP, using the ADAPT Portal and being exposed to ADAPT implementation strategies, collected using quantitative and qualitative methods. Data will be collected at T0 (baseline, after site engagement), T1 (6 months post Go-live) and T2 (12 months post Go-live).

Discussion

This will be the first cluster randomised trial to establish optimal levels of implementation effort and associated costs to achieve successful uptake of a clinical pathway within cancer care.

Trial registration

The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347

Related collections

Most cited references 16

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Sample size calculator for cluster randomized trials.

Marion K Campbell, Sean Thomson, Craig Ramsay … (2004)

Cluster randomized trials, where individuals are randomized in groups are increasingly being used in healthcare evaluation. The adoption of a clustered design has implications for design, conduct and analysis of studies. In particular, standard sample sizes have to be inflated for cluster designs, as outcomes for individuals within clusters may be correlated; inflation can be achieved either by increasing the cluster size or by increasing the number of clusters in the study. A sample size calculator is presented for calculating appropriate sample sizes for cluster trials, whilst allowing the implications of both methods of inflation to be considered.

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Author and article information

Contributors

Phyllis Butow: +612 93512859 , phyllis.butow@sydney.edu.au

Joanne Shaw: joanne.shaw@sydney.edu.au

Heather L. Shepherd:

ORCID: http://orcid.org/0000-0002-3350-1325

heather.shepherd@sydney.edu.au

Melanie Price: melanieanneprice@iinet.net.au

Lindy Masya: lindy.masya@sydney.edu.au

Brian Kelly: brian.kelly@newcastle.edu.au

Nicole M. Rankin: Nicole.Rankin@nswcc.org.au

Afaf Girgis: afaf.girgis@unsw.edu.au

Thomas F. Hack: THack@sbrc.ca

Philip Beale: Philip.Beale@health.nsw.gov.au

Rosalie Viney: Rosalie.Viney@chere.uts.edu.au

Haryana M. Dhillon: haryana.dhillon@sydney.edu.au

Joseph Coll: joseph.coll@att.net

Patrick Kelly: p.kelly@sydney.edu.au

Melanie Lovell: mlovell@hammond.com.au

Peter Grimison: peter.grimison@lh.org.au

Tim Shaw: tim.shaw@sydney.edu.au

Tim Luckett: Tim.Luckett@uts.edu.au

Jessica Cuddy: jessica.cuddy@sydney.edu.au

Fiona White: f.white@sydney.edu.au

Journal

Journal ID (nlm-ta): BMC Cancer

Journal ID (iso-abbrev): BMC Cancer

Title: BMC Cancer

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2407

Publication date (Electronic): 7 November 2018

Publication date PMC-release: 7 November 2018

Publication date Collection: 2018

Volume: 18

Electronic Location Identifier: 1077

Affiliations

[1 ]ISNI 0000 0004 1936 834X, GRID grid.1013.3, Psycho-Oncology Co-operative Research Group (PoCoG), , University of Sydney, ; Sydney, NSW 2006 Australia

[2 ]ISNI 0000 0000 8831 109X, GRID grid.266842.c, School of Medicine and Public Health, , University of Newcastle, ; Newcastle, NSW Australia

[3 ]ISNI 0000 0001 2166 6280, GRID grid.420082.c, Cancer Council NSW, ; Woolloomooloo, NSW Australia

[4 ]ISNI 0000 0004 4902 0432, GRID grid.1005.4, Centre for Oncology Education and Research Translation (CONCERT), Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, , University of New South Wales, ; Kensington, Australia

[5 ]ISNI 0000 0004 1936 9609, GRID grid.21613.37, College of Nursing, Rady Faculty of Health Sciences, , University of Manitoba, ; Winnipeg, Canada

[6 ]ISNI 0000 0001 0701 0170, GRID grid.419404.c, CancerCare Manitoba Research Institute, ; Winnipeg, Canada

[7 ]Cancer Services for the Sydney Local Health District (Incorporating Royal Prince Alfred, Concord and Canterbury Hospitals, Campsie, NSW Australia

[8 ]ISNI 0000 0004 1936 7611, GRID grid.117476.2, Centre for Health Economics Research and Evaluation, , University of Technology, ; Sydney, NSW Australia

[9 ]ISNI 0000 0004 1936 834X, GRID grid.1013.3, Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), , University of Sydney, ; Sydney, NSW Australia

[10 ]ISNI 0000 0004 1936 834X, GRID grid.1013.3, School of Public Health, , University of Sydney, ; Sydney, NSW Australia

[11 ]HammondCare Northern Sydney, Sydney, NSW Australia

[12 ]ISNI 0000 0004 1936 834X, GRID grid.1013.3, Northern Clinical School, , University of Sydney, ; Sydney, NSW Australia

[13 ]GRID grid.419783.0, Chris O’Brien Lifehouse, ; Camperdown, NSW Australia

[14 ]ISNI 0000 0004 1936 834X, GRID grid.1013.3, Sydney Medical School, , University of Sydney, ; Sydney, NSW Australia

[15 ]ISNI 0000 0004 1936 834X, GRID grid.1013.3, Charles Perkins Centre Faculty of Health Sciences, , University of Sydney, ; Sydney, NSW Australia

[16 ]ISNI 0000 0004 1936 7611, GRID grid.117476.2, Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), , University of Technology Sydney, ; Ultimo, NSW Australia

Author information

Heather L. Shepherd http://orcid.org/0000-0002-3350-1325

Article

Publisher ID: 4962

DOI: 10.1186/s12885-018-4962-9

PMC ID: 6223096

PubMed ID: 30404619

SO-VID: 034cb4e9-f60c-4006-8d0d-37c1fbe3ea96

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 12 July 2018

Date accepted : 16 October 2018

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100001171, Cancer Institute NSW;

Award ID: 14/TPB/1-02

Award Recipient : Phyllis Butow

Custom metadata

ScienceOpen disciplines: Oncology & Radiotherapy

Keywords: implementation,clinical pathways,cancer,anxiety and depression,cluster randomised controlled trial,health services,psycho-oncology

Data availability:

ScienceOpen disciplines: Oncology & Radiotherapy

Keywords: implementation, clinical pathways, cancer, anxiety and depression, cluster randomised controlled trial, health services, psycho-oncology

Comparison of implementation strategies to influence adherence to the clinical pathway for screening, assessment and management of anxiety and depression in adult cancer patients (ADAPT CP): study protocol of a cluster randomised controlled trial

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Abstract

Background

Methods

Discussion

Trial registration

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Karger: Oncology

Most cited references 16

Enabling the implementation of evidence based practice: a conceptual framework

Implementing clinical guidelines: current evidence and future implications.

Sample size calculator for cluster randomized trials.

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