Fig. 1

Spirit flow diagram of enrolment, interventions, and assessments for the COMBO study, a stepped-wedge cluster-randomized controlled trial. *Number of outpatient clinic visits varies between patients and depends on the stepped-wedge design of this trial. ^aBaseline variables: age, sex, center, nicotine and alcohol use, co-morbidity, etiology of chronic pancreatitis, disease duration, prior endoscopic- and/or surgical interventions, pancreatic function and medication use. ^bCo-primary endpoints: mean difference in quality of life (PANQOLI) and level of pain (Izbicki Pain Score) at 12 months after the end of the transition period for each cluster (intention-to-treat analysis) and at 12 months after start intervention for the individual patient defined as the first outpatient clinic visit after the kick-off meeting has been performed (per-protocol analysis). ^cSecondary endpoints comprise the following domains: (1) individual components of the co-primary endpoints, (2) process measure outcomes, (3) clinical outcomes (e.g., pancreatic function, nutritional status, bone health), (4) utilization of healthcare resources, and (5) social participation and are collected from patient records at 12 months after the end of the transition period for each cluster (intention-to-treat analysis) and at 12 months after start intervention for the individual patient defined as the first outpatient clinic visit after the kick-off meeting has been performed (per-protocol analysis)