Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial

Not Applicable

Active, not recruiting

• Conditions: Polypharmacy

• Registration Number: NCT05656560
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-12-09
• Study First Posted: 2022-12-19
• Study Start: 2023-06-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-05-10
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 786

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States