Design of a pragmatic cluster randomized controlled trial: Reducing high risk polypharmacy using behavioral economics through electronic health records.

Authors

Lucia C Petito, Jonathan Arnold, Mark W Friedberg, Tiffany Brown, Ji Young Lee, Yaw Peprah, Neelima Pathri, Timothy M Bober, Stephen Handler, Sara Bradley, Michael Schachter, Ryan Chmiel, Mark Sullivan, Jason N Doctor, Daniella Meeker, Noah Goldstein, Craig R Fox, Jeffrey A Linder, Stephen D Persell

Published in

Contemporary clinical trials. Pages 108522. Nov 02, 2026. Epub Nov 02, 2026.

Abstract

Inappropriate polypharmacy can lead to harms among older adults. Behavioral nudges delivered using decision support in electronic health records (EHR) may be a scalable way to reduce polypharmacy. The goal of the High-Risk PolyPharmacy (HRPP) trial is to evaluate the effectiveness of a 'commitment nudge' and a 'justification nudge' alone and in combination on reducing HRPP via a pragmatic, clinic-randomized trial among patients aged 65 years and older.
This 2 × 2 clinic-randomized factorial trial in primary care clinics in two health systems has four parallel arms: EHR commitment nudge, EHR justification nudge, both, or neither, all coupled with optional clinician education activities. Eligible patients are aged ≥65 years actively using ≥5 systemic, oral medications. The primary outcome is a composite of seven indicators of HRPP. Secondary outcomes include the individual components of HRPP and measures of health system burden: all-cause and adverse drug event-specific emergency department (ED) visits and ED visits followed by hospitalization.
We used constrained randomization to produce balance between study arms for 124 primary care clinics comprising 804 clinicians. At randomization, the median (range) practice had 573 (326-947) eligible patients; the average clinic-level prevalence of HRPP among these patients was 30.0%. The 18-month intervention began in 2023-October and 2024-November at NM and UPMC, respectively. Data collection will end in 2026-April at NM and 2026-December at UPMC.
This trial is evaluating the effectiveness and safety of EHR-embedded interventions to reduce HRPP. If successful, this intervention could offer a low-cost, scalable solution.
NCT05656560.

PMID:
42971398
Bibliographic data and abstract were imported from PubMed on 03 Nov 2026.

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