An App-Based Proton Pump Inhibitor Discontinuation Tool: A Multicentre, Open-Label, Randomised Superiority Trial.

backgroundProton pump inhibitors (PPIs) are frequently used without long-term indication. Discontinuation remains challenging because of rebound symptoms. Whether digital guidance tools improve discontinuation is unknown. We evaluated whether an app improves PPI discontinuation.

methodsIn this open-label adaptive randomised controlled superiority trial, adults using daily PPI for ≥ 4 weeks without chronic PPI indication, according to the Dutch College of General Practitioners guideline, were recruited from outpatient clinics of Internal Medicine, Gastroenterology, Rheumatology and Nephrology departments at three Dutch hospitals. Patients were excluded if their physician deemed PPI use necessary beyond guideline recommendations, after prior upper gastrointestinal surgery, in case of inability to understand the study, unavailability of a smartphone/tablet, or limited life expectancy. Patients were randomly assigned (1:1), stratified by department and initial indication, to receive information on PPI discontinuation through an app (intervention) or brochure (control). Primary outcome was PPI discontinuation at 2 months follow-up, defined as self-declared intake of ≤ 1 tablet in the preceding 14 days. Sample-size was revised earlier than prespecified based on interim data. The trial is registered as closed to accrual at ClinicalTrials.gov (NCT05348252).

resultsBetween May 15, 2022, and March 31, 2023, 174 patients were randomized (86 intervention, 88 control). Nine and two patients, respectively, did not receive the allocated intervention. Of the 163 participants (mean age 54 y/o [SD 11], 76 males [47%]), 66/77 (86%) discontinued PPIs in the intervention group versus 55/86 (64%) in the control group (RR 1.34, 95% CI 1.11-1.61, p = 0.002). Adverse events occurred in 18/121 (15%) patients who discontinued PPI use and in 6/42 (14%) who did not. Only 4/121 (3%) and 1/42 (2%), respectively, were potentially attributable to PPI discontinuation.

conclusionAn app-based intervention significantly improves discontinuation of inappropriate PPI use compared with an information brochure and could therefore be considered for PPI deprescribing initiatives.