Randomized Controlled Trial

. 2018 Nov 7;18(1):1077.

doi: 10.1186/s12885-018-4962-9.

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

Phyllis Butow¹, Joanne Shaw², Heather L Shepherd², Melanie Price², Lindy Masya², Brian Kelly^{2

3}, Nicole M Rankin^{2

4}, Afaf Girgis^{2

5}, Thomas F Hack^{6

7}, Philip Beale⁸, Rosalie Viney⁹, Haryana M Dhillon^{2

10}, Joseph Coll², Patrick Kelly¹¹, Melanie Lovell^{12

13}, Peter Grimison^{14

15}, Tim Shaw¹⁶, Tim Luckett¹⁷, Jessica Cuddy², Fiona White²; ADAPT Program Group

Collaborators, Affiliations

Collaborators

Affiliations

¹ Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Sydney, NSW, 2006, Australia. phyllis.butow@sydney.edu.au.
² Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Sydney, NSW, 2006, Australia.
³ School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.
⁴ Cancer Council NSW, Woolloomooloo, NSW, Australia.
⁵ 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.
⁶ College of Nursing, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada.
⁷ CancerCare Manitoba Research Institute, Winnipeg, Canada.
⁸ Cancer Services for the Sydney Local Health District (Incorporating Royal Prince Alfred, Concord and Canterbury Hospitals, Campsie, NSW, Australia.
⁹ Centre for Health Economics Research and Evaluation, University of Technology, Sydney, NSW, Australia.
¹⁰ Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), University of Sydney, Sydney, NSW, Australia.
¹¹ School of Public Health, University of Sydney, Sydney, NSW, Australia.
¹² HammondCare Northern Sydney, Sydney, NSW, Australia.
¹³ Northern Clinical School, University of Sydney, Sydney, NSW, Australia.
¹⁴ Chris O'Brien Lifehouse, Camperdown, NSW, Australia.
¹⁵ Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
¹⁶ Charles Perkins Centre Faculty of Health Sciences, University of Sydney, Sydney, NSW, Australia.
¹⁷ Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), University of Technology Sydney, Ultimo, NSW, Australia.

PMID: 30404619
PMCID: PMC6223096
DOI: 10.1186/s12885-018-4962-9

Randomized Controlled Trial

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

Phyllis Butow et al. BMC Cancer. 2018.

. 2018 Nov 7;18(1):1077.

doi: 10.1186/s12885-018-4962-9.

Authors

Collaborators

Affiliations

¹ Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Sydney, NSW, 2006, Australia. phyllis.butow@sydney.edu.au.
² Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Sydney, NSW, 2006, Australia.
³ School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.
⁴ Cancer Council NSW, Woolloomooloo, NSW, Australia.
⁵ 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.
⁶ College of Nursing, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada.
⁷ CancerCare Manitoba Research Institute, Winnipeg, Canada.
⁸ Cancer Services for the Sydney Local Health District (Incorporating Royal Prince Alfred, Concord and Canterbury Hospitals, Campsie, NSW, Australia.
⁹ Centre for Health Economics Research and Evaluation, University of Technology, Sydney, NSW, Australia.
¹⁰ Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), University of Sydney, Sydney, NSW, Australia.
¹¹ School of Public Health, University of Sydney, Sydney, NSW, Australia.
¹² HammondCare Northern Sydney, Sydney, NSW, Australia.
¹³ Northern Clinical School, University of Sydney, Sydney, NSW, Australia.
¹⁴ Chris O'Brien Lifehouse, Camperdown, NSW, Australia.
¹⁵ Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
¹⁶ Charles Perkins Centre Faculty of Health Sciences, University of Sydney, Sydney, NSW, Australia.
¹⁷ Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), University of Technology Sydney, Ultimo, NSW, Australia.

PMID: 30404619
PMCID: PMC6223096
DOI: 10.1186/s12885-018-4962-9

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.

Keywords: Anxiety and depression; Cancer; Clinical pathways; Cluster randomised controlled trial; Health services; Implementation; Psycho-oncology.

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Conflict of interest statement

Authors’ information

Not applicable.

Ethics approval and consent to participate

This research is being conducted in accordance with the Declaration of Helsinki and Ethical Approval for this study has been granted by Sydney Local Health District (RPAH Zone) Human Research Ethics Committee, Protocol X16-0378 HREC/16/RPAH/522. Research Participation Agreement and Governance Approvals have been obtained from individual participating institutions. Protocol amendments will be submitted to to the HREC as required throughout the duration of the study.

Cancer service staff at participating cancer services will be give their consent when invited to complete surveys and participate in interviews. Patients at each site participate in the ADAPT CP as part of routine care (which they are offered and can refuse). Patients provide informed consent to collection of health service usage data from the Medical and Pharmaceutical Benefit Schemes in Australia by the research team.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Authors’ information

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

Similar articles

Cited by

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous