Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial
NCT05656560 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 786
Last updated 2026-04-29
Summary
High-risk polypharmacy is common among older adults in the United States, is particularly dangerous for individuals with dementia or cognitive impairment, and is associated with harms such as adverse drug reactions, falls, and higher costs of care. This project aims to test in a pragmatic clinic-randomized controlled trial two electronic health record-based behavioral economic nudges to help clinicians reduce high-risk polypharmacy among their older adult patients and in the subgroup with dementia or cognitive impairment.
The main questions this trial aims to answer are:
Aim 1: To evaluate the effects of an EHR-based commitment nudge, a justification nudge, and the combination of both nudges on a composite measure of high-risk polypharmacy via a pragmatic randomized controlled trial. The investigators will use cluster randomization in which primary care clinics are randomized to receive 0, 1, or 2 nudges using a factorial design. The nudges will run for 18 months, followed by 12 months of observation to assess persistence of effects.
Aim 2: To qualitatively and quantitatively assess clinician experiences with the EHR-based nudges, including their acceptability and effects on workflow. At the conclusion of the intervention period, the investigators will perform semi-structured interviews and field a clinician survey.
Conditions
- Polypharmacy
Interventions
- BEHAVIORAL
-
Clinical decision support (CDS)-Commitment nudge
EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy
- OTHER
-
Clinician education
Brief, online education module for primary care clinicians
- BEHAVIORAL
-
Clinical decision support (CDS)-Justification nudge
EHR clinical decision support alerts-clinician rational for high risk polypharmacy
Sponsors & Collaborators
-
National Institute on Aging (NIA)
collaborator NIH -
University of Pittsburgh Medical Center
collaborator OTHER -
University of Southern California
collaborator OTHER -
University of California, Los Angeles
collaborator OTHER - lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-08
- Primary Completion
- 2026-05-10
- Completion
- 2027-05-31
Countries
- United States
Study Locations
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