Implementation study of an evidence-based management algorithm for patients with chronic pancreatitis

Rationale: Chronic pancreatitis is associated with a markedly reduced life-expectancy and quality of life. In a recently performed study, current care for patients with chronic pancreatitis in the Netherlands proved not to be in accordance with the in 2017 published European guideline. This may indicate suboptimal care for these patients. Implementation of an evidence-based management algorithm to standardize care could improve this level of care, lower the complication rate and improve the quality of life for patients with chronic pancreatitis.

Objective: To assess whether standardized care through the implementation of an evidence-based management algorithm of interventions for patients with chronic pancreatitis results in an improvement in quality of life and reduction of pain severity as compared to current practice.

Study design: A nationwide stepped-wedge, cluster randomized controlled trial. All participating hospitals cross over from current practice to care according to the treatment algorithm. The sequence of crossing over is randomized. Study participants will be enrolled during the current practice phase and be followed longitudinally until the end of the study. In the end, this evidence-based management algorithm will be implemented in all participating hospitals.

Intervention: Evidence-based management algorithm

Comparison: Care for chronic pancreatitis patients according to current practice.

Endpoints: In this study, there are two co-primary outcomes: quality of life and pain severity. Both will be measured longitudinally in all included patients. Follow-up period will be a minimum of 12 months after start intervention.

The hypothesis of this study is that implementation of an evidence-based management algorithm to standardize care will improve the level of care, lower the complication rate and improve the quality of life for patients with chronic pancreatitis.

The patient follow-up will be completed 35 months after randomization to determine the order in which each cluster group will undergo the cross-over.

Evidence-based management algorithm consisting of a combination of interventions, all considered as part of best practice, based on the recommendations of the United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (2017) and an extensive systematic literature analysis.