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

Autor: David C. Currow, Tim Luckett, Lawrence T. Lam, Nicola McCaffrey, Meera Agar, Frances M. Boyle, Alison Read, Jane Phillips, Tim Shaw, Annmarie Hosie, Patricia M. Davidson, Melanie Lovell
Rok vydání: 2018
Předmět:
Oncology
Male
Translation
Palliative care
Cost effectiveness
Cost-Benefit Analysis
Study Protocol
0302 clinical medicine
Neoplasms
Outpatients
Ambulatory Care
Cluster Analysis
Multicenter Studies as Topic
030212 general & internal medicine
Cluster randomised controlled trial
Early Detection of Cancer
Randomized Controlled Trials as Topic
Cancer
lcsh:Public aspects of medicine
Health Policy
Palliative Care
Cancer Pain
Patient education
Health professional education
030220 oncology & carcinogenesis
Health Policy & Services
Female
Adult
medicine.medical_specialty
Pain
Guidelines
Clinical change champions
03 medical and health sciences
Quality of life (healthcare)
Internal medicine
Audit and feedback
medicine
Self-management
Humans
Pain Management
business.industry
Australia
lcsh:RA1-1270
Guideline
Clinical trial
Clinical Trials
Phase III as Topic
Implementation
Quality of Life
Cancer pain
business
Zdroj: BMC Health Services Research
BMC Health Services Research, Vol 18, Iss 1, Pp 1-13 (2018)
ISSN: 1472-6963
Popis: © 2018 The Author(s). 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).
Databáze: OpenAIRE
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