Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial
Open Access
- 16 April 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Trials
- Vol. 21 (1), 1-18
- https://doi.org/10.1186/s13063-020-4180-z
Abstract
Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life. PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide. The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life. ClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.Funding Information
- KWF Kankerbestrijding (UVA2013-5842)
This publication has 28 references indexed in Scilit:
- The Randomized Registry Trial — The Next Disruptive Technology in Clinical Research?The New England Journal of Medicine, 2013
- Stepped wedge designs could reduce the required sample size in cluster randomized trialsJournal of Clinical Epidemiology, 2013
- SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical TrialsAnnals of Internal Medicine, 2013
- Consort 2010 statement: extension to cluster randomised trialsBMJ, 2012
- Informed Consent and Cluster-Randomized TrialsAmerican Journal of Public Health, 2012
- Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementationJournal of Clinical Epidemiology, 2011
- Effects of evidence-based clinical practice guidelines on quality of care: a systematic reviewQuality and Safety in Health Care, 2009
- Design and analysis of stepped wedge cluster randomized trialsContemporary Clinical Trials, 2007
- Randomized clinical trial of pylorus-preserving duodenopancreatectomy versus classical Whipple resection—long term resultsBritish Journal of Surgery, 2005
- Curative resection is the single most important factor determining outcome in patients with pancreatic adenocarcinomaBritish Journal of Surgery, 2004