Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial (HRPP)

Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Polypharmacy
• Intervention / Treatment: Other: Clinician education; Behavioral: Clinical decision support (CDS)-Commitment nudge; Behavioral: Clinical decision support (CDS)-Justification nudge

• Study Type: Interventional
• Enrollment (Actual): 786
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Northwestern Medicine or UPMC primary care clinic: Internal Medicine, Family Medicine, or General Practice or Geriatrics

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Clinician education only; Online clinician education	Other: Clinician education; Brief, online education module for primary care clinicians
Experimental: 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.	Other: Clinician education; Brief, online education module for primary care clinicians; Behavioral: Clinical decision support (CDS)-Commitment nudge; EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy; Other Names: Commitment nudge
Experimental: 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.	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; Other Names: Justification nudge
Experimental: Commitment nudge + Justification nudge; This study arm will receive both the commitment nudge and the justification nudge.	Other: Clinician education; Brief, online education module for primary care clinicians; Behavioral: Clinical decision support (CDS)-Commitment nudge; EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy; Other Names: Commitment nudge; Behavioral: Clinical decision support (CDS)-Justification nudge; EHR clinical decision support alerts-clinician rational for high risk polypharmacy; Other Names: Justification nudge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure)	The composite of the 7 high-risk polypharmacy measures (Secondary outcomes #6-12)	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of Emergency Department visits per patient -all cause	Denominator: All older adults with HRPP. Numerator: Patients with an emergency department encounter during the look back period.	18 months
The rate of Emergency Department visits per patient-Adverse drug event (ADE)-specific	Denominator: All older adults with HRPP. Numerator: Patients with an emergency department encounter for ADE during the look back period.	18 months
The rate of hospital admissions per patient-all cause	Denominator: All older adults with HRPP. Numerator: Patients with an inpatient admission for any reason during the look back period.	18 months
The rate of hospital admissions per patient-ADE-specific	Denominator: All older adults with HRPP. Numerator: Patients with an inpatient admission for ADE during the look back period.	18 months
The percentage of HRPP patients with a fall condition-drug interaction	Denominator: All older adult patients with HRPP with a fall marker. Numerator: Patients with an active eligible fall risk medication on medication list.	18 months
The percentage of HRPP patients with a fall drug-drug interaction	Denominator: All older adult patients with HRPP. Numerator: Patients with greater than or equal to 3 active eligible fall risk medications.	18 months
The percentage of HRPP patients with Heart failure-NSAID interaction	Denominator: All older adult patients with HRPP with a CHF marker. Numerator: Patients with an active eligible NSAID medication.	18 months
The percentage of HRPP patients with Heart Failure-thiazolidinedione interaction	Denominator: All older adults with HRPP with a CHF marker. Numerator: Patients with an active eligible thiazolidinedione medication.	18 months
The percentage of HRPP patients with Heart failure with reduced ejection fraction- non-dihydropyridine calcium channel blocker interaction	Denominator: All older adults with HRPP with CHFlowEF marker. Numerator: Patients with an active eligible calcium channel blocker medication.	18 months
The percentage of HRPP patients with CKD-glyburide/glimepiride interaction	Denominator: All older adults with HRPP with most-recent eGFR <60. Numerator: Patients with an active eligible glyburide-containing medication.	18 months
The percentage of HRPP patients with CKD-NSAID interaction	Denominator: All older adults with HRPP with most-recent eGFR < 30. Numerator: Patients with an active eligible NSAID medication.	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of HRPP patients with a hospitalization or emergency department (ED) visit for seizure.	Safety measure for discontinuing or reducing benzodiazepines and anticonvulsants	18 months
The percentage of HRPP patients with a hospitalization or ED visit for opioid withdrawal.	Safety measure for discontinuing or reducing opioids	18 months
The percentage of HRPP patients with a hospitalization or ED visit for hyperglycemia.	Safety measure for discontinuing or reducing glyburide, glimepiride, and thiazolidinediones	18 months
The percentage of HRPP patients with a hospitalization or ED visit for pain.	Safety measure for discontinuing or reducing tricyclic antidepressants, gabapentinoids, serotonin and norepinephrine reuptake inhibitors, opioids, and NSAIDs	18 months
The percentage of HRPP patients with a hospitalization or ED visit for depression or suicidality	Safety measure for discontinuing or reducing tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors and selective serotonin reuptake inhibitors	18 months
The percentage of HRPP patients with a hospitalization or ED visit for anxiety.	Safety measure for discontinuing or reducing benzodiazepines, serotonin and norepinephrine reuptake inhibitors and selective serotonin reuptake inhibitors	18 months
The percentage of HRPP patients with a hospitalization or ED visit for sedative withdrawal.	Safety measure for discontinuing or reducing benzodiazepines and Z-drugs (GABA receptor modulators)	18 months
The percentage of HRPP patients with a hospitalization or ED visit for behavioral disturbance in dementia or psychosis.	Safety measure for discontinuing or reducing antipsychotics	18 months
The percentage of HRPP patients with a hospitalization or ED visit for tachycardia (other than ventricular) or hypertensive emergency.	Safety measure for discontinuing or reducing non-dihydropyridine calcium channel blockers	18 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of California, Los Angeles; National Institute on Aging (NIA); University of Southern California; University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Actual): May 11, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: clinical decision support; behavioral economics; electronic health record; high-risk geriatric polypharmacy
• Other Study ID Numbers: STU00213231; R01AG070054 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No