Implementation of an evidence-based management algorithm for patients with chronic pancreatitis (COMBO trial): study protocol for a stepped-wedge cluster-randomized controlled trial

Trials, vol. 24, pp. 18

Abstract

BACKGROUND: Chronic pancreatitis (CP) is an inflammatory disease that may be complicated by abdominal pain, pancreatic dysfunction, nutritional deficiencies, and diminished bone density. Importantly, it is also associated with a substantially impaired quality of life and reduced life expectancy. This may partly be explained by suboptimal treatment, in particular the long-term management of this chronic condition, despite several national and international guidelines. Standardization of care through a structured implementation of guideline recommendations may improve the level of care and lower the complication rate of these patients. Therefore, the aim of the present study is to evaluate to what extent patient education and standardization of care, through the implementation of an evidence-based integrated management algorithm, improve quality of life and reduce pain severity in patients with CP. METHODS: The COMBO trial is a nationwide stepped-wedge cluster-randomized controlled trial. In a stepwise manner, 26 centers, clustered in 6 health regions, cross-over from current practice to care according to an evidence-based integrated management algorithm. During the current practice phase, study participants are recruited and followed longitudinally through questionnaires. Individual patients contribute data to both study periods. Co-primary study endpoints consist of quality of life (assessed by the PANQOLI score) and level of pain (assessed by the Izbicki questionnaire). Secondary outcomes include process measure outcomes, clinical outcomes (e.g., pancreatic function, nutritional status, bone health, interventions, medication use), utilization of healthcare resources, (in) direct costs, and the level of social participation. Standard follow-up is 35 months from the start of the trial. DISCUSSION: This is the first stepped-wedge cluster-randomized controlled trial to investigate whether an evidence-based integrated therapeutic approach improves quality of life and pain severity in patients with CP as compared with current practice. TRIAL REGISTRATION: ISRCTN, ISRCTN13042622. Registered on 5 September 2020.

Authors 10

1. Florence E.M. de Rijk corresponding

   Erasmus MC · St. Antonius Ziekenhuis · Erasmus University Rotterdam

   Affiliation as printed

   Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. f.derijk@erasmusmc.nl

   Department of Research and Development, St. Antonius Hospital, Nieuwegein, The Netherlands. f.derijk@erasmusmc.nl

   Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands

2. Charlotte L. van Veldhuisen

   Amsterdam UMC Location University of Amsterdam · St. Antonius Ziekenhuis · Amsterdam Gastroenterology Endocrinology Metabolism

   Affiliation as printed

   Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands

   Department of Research and Development, St. Antonius Hospital, Nieuwegein, The Netherlands

   Department of Surgery, Amsterdam UMC, Location University of Amsterdam, Amsterdam, The Netherlands

3. Marc G. Besselink

   Amsterdam UMC Location University of Amsterdam · Amsterdam Gastroenterology Endocrinology Metabolism

   Affiliation as printed

   Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands

   Department of Surgery, Amsterdam UMC, Location University of Amsterdam, Amsterdam, The Netherlands

4. Jeanin Elise van Hooft Aachen Department of Gastroenterology and Hepatology

   Leiden University Medical Center

   Affiliation as printed

   Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands

5. Hjalmar C. van Santvoort

   University Medical Center Utrecht · St. Antonius Ziekenhuis

   Affiliation as printed

   Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands

   Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands

6. Erwin J. M. van Geenen

   Radboud University Medical Center

   Affiliation as printed

   Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands

7. Cornelis H. van Werkhoven
   Affiliation as printed

   Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands

8. Pieter Jan F. de Jonge

   Erasmus MC · Erasmus University Rotterdam

   Affiliation as printed

   Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands

9. Marco J. Bruno

   Erasmus MC · Erasmus University Rotterdam

   Affiliation as printed

   Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands

10. Robert C. Verdonk

    St. Antonius Ziekenhuis

    Affiliation as printed

    Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands