Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial
NCT ID: NCT05656560
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
786 participants
INTERVENTIONAL
2023-06-08
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase
NCT03791580
Population Health Approach to Optimizing Medications in Older Adults
NCT06110156
Reduction of Polypharmacy in Elderly People With Multiple Diseases
NCT05526963
NUDGE-EHR Replication Trial at Mass General Brigham
NCT05538065
Testing the Impact of Pre-visit Priming for Medications
NCT07281131
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Clinician education only
Online clinician education
Clinician education
Brief, online education module for primary care clinicians
Commitment nudge
The commitment nudge will be an EHR alert that is triggered when a clinician renews or orders a qualifying medication in any Epic encounter (including non-face-to-face encounters) for a patient aged 65 or greater who meets criteria for high-risk polypharmacy. When triggered, the commitment nudge will offer the clinician a choice option that sets a reminder to discuss polypharmacy at the patient's next visit date.
Clinical decision support (CDS)-Commitment nudge
EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy
Clinician education
Brief, online education module for primary care clinicians
Justification nudge
The justification nudge will be an EHR alert triggered for patients with high-risk polypharmacy when a clinician begins to renew or newly prescribe a medication that causes a high-risk criterion to be fulfilled (i.e., a medication meeting causing 1 of the 7 high-risk polypharmacy criteria/primary study measures to be met). This alert will inform the clinician of the high-risk nature of the prescription and request a free-text justification for starting or renewing the medication. This written justification will appear in the EHR in a section of that encounter that other EHR users can see.
Clinician education
Brief, online education module for primary care clinicians
Clinical decision support (CDS)-Justification nudge
EHR clinical decision support alerts-clinician rational for high risk polypharmacy
Commitment nudge + Justification nudge
This study arm will receive both the commitment nudge and the justification nudge.
Clinical decision support (CDS)-Commitment nudge
EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy
Clinician education
Brief, online education module for primary care clinicians
Clinical decision support (CDS)-Justification nudge
EHR clinical decision support alerts-clinician rational for high risk polypharmacy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinical decision support (CDS)-Commitment nudge
EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy
Clinician education
Brief, online education module for primary care clinicians
Clinical decision support (CDS)-Justification nudge
EHR clinical decision support alerts-clinician rational for high risk polypharmacy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Aging (NIA)
NIH
University of Pittsburgh Medical Center
OTHER
University of Southern California
OTHER
University of California, Los Angeles
OTHER
Northwestern University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stephen Persell, MD, MPH
Professor; Director, Center for Primary Care Innovation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northwestern Medicine
Chicago, Illinois, United States
UPMC
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STU00213231
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.