Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial

Not Applicable

Active, not recruiting

• Conditions: Polypharmacy
• Interventions: Behavioral: Clinical decision support (CDS)-Commitment nudge; Behavioral: Clinical decision support (CDS)-Justification nudge; Other: Clinician education

• 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

Arm && Interventions

Group	Intervention	Description
Justification nudge	Clinical decision support (CDS)-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.
Commitment nudge	Clinician education	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.
Commitment nudge + Justification nudge	Clinician education	This study arm will receive both the commitment nudge and the justification nudge.
Commitment nudge	Clinical decision support (CDS)-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.
Commitment nudge + Justification nudge	Clinical decision support (CDS)-Commitment nudge	This study arm will receive both the commitment nudge and the justification nudge.
Commitment nudge + Justification nudge	Clinical decision support (CDS)-Justification nudge	This study arm will receive both the commitment nudge and the justification nudge.
Clinician education only	Clinician education	Online clinician education
Justification nudge	Clinician education	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.

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 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 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 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)

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States