Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services: the Stop Cancer PAIN trial
Abstract Background Pain is a common and distressing symptom in people with cancer, but is under-recognised and under-treated. Australian guidelines for ‘Cancer Pain Management in Adults’ are available on the Cancer Council Australia Cancer Guideline Wiki. This study aims to evaluate the effectivene...
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| Format: | Article |
| Language: | English |
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BMC
2018-07-01
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| Series: | BMC Health Services Research |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12913-018-3318-0 |
| _version_ | 1819102643247644672 |
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| author | Tim Luckett Jane Phillips Meera Agar Lawrence Lam Patricia M. Davidson Nicola McCaffrey Frances Boyle Tim Shaw David C. Currow Alison Read Annmarie Hosie Melanie Lovell |
| author_facet | Tim Luckett Jane Phillips Meera Agar Lawrence Lam Patricia M. Davidson Nicola McCaffrey Frances Boyle Tim Shaw David C. Currow Alison Read Annmarie Hosie Melanie Lovell |
| author_sort | Tim Luckett |
| collection | DOAJ |
| description | Abstract Background Pain is a common and distressing symptom in people with cancer, but is under-recognised and under-treated. Australian guidelines for ‘Cancer Pain Management in Adults’ are available on the Cancer Council Australia Cancer Guideline Wiki. This study aims to evaluate the effectiveness and cost-effectiveness of a suite of guideline implementation strategies for improving pain outcomes in adults with cancer in oncology and palliative care outpatient settings. Methods The study will use a stepped-wedge cluster randomised controlled design, with oncology and palliative care outpatient services as the clusters. Patients will be eligible if they are adults with cancer and pain presenting to participating services during the study period. During an initial control arm, services will routinely screen patients for average and worst pain over the past 24 h using a 0–10 numerical rating scale (NRS) and have unfettered access to online guidelines. During the intervention arm, staff at each service will be encouraged to use: 1) a patient education booklet and self-management resource; 2) an online spaced learning cancer pain education module for clinicians from different disciplines; and 3) audit and feedback of service performance on key indices of cancer pain screening, assessment and management. Service-based clinical change champions will lead implementation of these strategies. The trial’s primary outcome will be the probability that patients initially screened as having moderate-severe (≥5/10 NRS) worst pain experience a clinically important improvement one week later, defined as ≥ 30% reduction. Secondary outcomes will include patient empowerment and quality of life, carer experience, and cost-effectiveness. For the main analysis, linear mixed models will be used, accounting for clustering and the longitudinal design. Eighty-two patients per service at six services (N = 492) will provide > 90% power. A qualitative sub-study and analyses of structural and process factors will explore opportunities for further refinement and tailoring of the intervention. Discussion This pragmatic trial will inform implementation of guidelines across a range of oncology and palliative care outpatient service contexts. If found effective, the implementation strategies will be made freely available on the Wiki alongside the guidelines. Trial registration Registered 23/01/2015 on the Australian New Zealand Clinical Trials Registry (ACTRN12615000064505). |
| first_indexed | 2024-12-22T01:37:49Z |
| format | Article |
| id | doaj.art-396cf2c1e175409d9b107c2510b27ead |
| institution | Directory Open Access Journal |
| issn | 1472-6963 |
| language | English |
| last_indexed | 2024-12-22T01:37:49Z |
| publishDate | 2018-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Health Services Research |
| spelling | doaj.art-396cf2c1e175409d9b107c2510b27ead2022-12-21T18:43:19ZengBMCBMC Health Services Research1472-69632018-07-0118111310.1186/s12913-018-3318-0Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services: the Stop Cancer PAIN trialTim Luckett0Jane Phillips1Meera Agar2Lawrence Lam3Patricia M. Davidson4Nicola McCaffrey5Frances Boyle6Tim Shaw7David C. Currow8Alison Read9Annmarie Hosie10Melanie Lovell11Faculty of Health, IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation Sydney), University of Technology Sydney (UTS)Faculty of Health, IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation Sydney), University of Technology Sydney (UTS)Faculty of Health, IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation Sydney), University of Technology Sydney (UTS)Tung Wah CollegeSchool of Nursing, Johns Hopkins UniversityDeakin Health Economics, Centre for Population Health Research, School of Health and Social Development, Deakin UniversityThe Mater Hospital, Cancer CareFaculty of Health Sciences, Charles Perkins Centre, The University of SydneyFaculty of Health, IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation Sydney), University of Technology Sydney (UTS)Department of Renal/Oncology, Gosford HospitalFaculty of Health, IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation Sydney), University of Technology Sydney (UTS)Department of Palliative Care, HammondCare, Greenwich HospitalAbstract Background Pain is a common and distressing symptom in people with cancer, but is under-recognised and under-treated. Australian guidelines for ‘Cancer Pain Management in Adults’ are available on the Cancer Council Australia Cancer Guideline Wiki. This study aims to evaluate the effectiveness and cost-effectiveness of a suite of guideline implementation strategies for improving pain outcomes in adults with cancer in oncology and palliative care outpatient settings. Methods The study will use a stepped-wedge cluster randomised controlled design, with oncology and palliative care outpatient services as the clusters. Patients will be eligible if they are adults with cancer and pain presenting to participating services during the study period. During an initial control arm, services will routinely screen patients for average and worst pain over the past 24 h using a 0–10 numerical rating scale (NRS) and have unfettered access to online guidelines. During the intervention arm, staff at each service will be encouraged to use: 1) a patient education booklet and self-management resource; 2) an online spaced learning cancer pain education module for clinicians from different disciplines; and 3) audit and feedback of service performance on key indices of cancer pain screening, assessment and management. Service-based clinical change champions will lead implementation of these strategies. The trial’s primary outcome will be the probability that patients initially screened as having moderate-severe (≥5/10 NRS) worst pain experience a clinically important improvement one week later, defined as ≥ 30% reduction. Secondary outcomes will include patient empowerment and quality of life, carer experience, and cost-effectiveness. For the main analysis, linear mixed models will be used, accounting for clustering and the longitudinal design. Eighty-two patients per service at six services (N = 492) will provide > 90% power. A qualitative sub-study and analyses of structural and process factors will explore opportunities for further refinement and tailoring of the intervention. Discussion This pragmatic trial will inform implementation of guidelines across a range of oncology and palliative care outpatient service contexts. If found effective, the implementation strategies will be made freely available on the Wiki alongside the guidelines. Trial registration Registered 23/01/2015 on the Australian New Zealand Clinical Trials Registry (ACTRN12615000064505).http://link.springer.com/article/10.1186/s12913-018-3318-0CancerPainGuidelinesImplementationTranslationSelf-management |
| spellingShingle | Tim Luckett Jane Phillips Meera Agar Lawrence Lam Patricia M. Davidson Nicola McCaffrey Frances Boyle Tim Shaw David C. Currow Alison Read Annmarie Hosie Melanie Lovell Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services: the Stop Cancer PAIN trial BMC Health Services Research Cancer Pain Guidelines Implementation Translation Self-management |
| title | Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services: the Stop Cancer PAIN trial |
| title_full | Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services: the Stop Cancer PAIN trial |
| title_fullStr | Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services: the Stop Cancer PAIN trial |
| title_full_unstemmed | Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services: the Stop Cancer PAIN trial |
| title_short | Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services: the Stop Cancer PAIN trial |
| title_sort | protocol for a phase iii pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost effectiveness of screening and guidelines with versus without implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services the stop cancer pain trial |
| topic | Cancer Pain Guidelines Implementation Translation Self-management |
| url | http://link.springer.com/article/10.1186/s12913-018-3318-0 |
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