NCT05656560

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
786

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jun 2023May 2027

First Submitted

Initial submission to the registry

November 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

June 8, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2026

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Expected
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

November 17, 2022

Last Update Submit

May 21, 2026

Conditions

Polypharmacy

Keywords

clinical decision supportelectronic health recordbehavioral economicshigh-risk geriatric polypharmacy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • The rate of Emergency Department visits per patient -all cause

    18 months

  • The rate of Emergency Department visits per patient-Adverse drug event (ADE)-specific

    18 months

  • The rate of hospital admissions per patient-all cause

    18 months

  • The rate of hospital admissions per patient-ADE-specific

    18 months

  • The percentage of HRPP patients with a fall condition-drug interaction

    18 months

  • +6 more secondary outcomes

Other Outcomes (9)

  • The percentage of HRPP patients with a hospitalization or emergency department (ED) visit for seizure.

    18 months

  • The percentage of HRPP patients with a hospitalization or ED visit for pain.

    18 months

  • The percentage of HRPP patients with a hospitalization or ED visit for depression or suicidality

    18 months

  • +6 more other outcomes

Study Arms (4)

Clinician education only

OTHER

Online clinician education

Other: Clinician education

Commitment nudge

EXPERIMENTAL

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.

Behavioral: Clinical decision support (CDS)-Commitment nudgeOther: Clinician education

Justification nudge

EXPERIMENTAL

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 educationBehavioral: Clinical decision support (CDS)-Justification nudge

Commitment nudge + Justification nudge

EXPERIMENTAL

This study arm will receive both the commitment nudge and the justification nudge.

Behavioral: Clinical decision support (CDS)-Commitment nudgeOther: Clinician educationBehavioral: Clinical decision support (CDS)-Justification nudge

Interventions

Clinical decision support (CDS)-Commitment nudgeBEHAVIORAL

EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy

Also known as: Commitment nudge
Commitment nudgeCommitment nudge + Justification nudge
Clinician educationOTHER

Brief, online education module for primary care clinicians

Clinician education onlyCommitment nudgeCommitment nudge + Justification nudgeJustification nudge
Clinical decision support (CDS)-Justification nudgeBEHAVIORAL

EHR clinical decision support alerts-clinician rational for high risk polypharmacy

Also known as: Justification nudge
Commitment nudge + Justification nudgeJustification nudge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor; Director, Center for Primary Care Innovation

Study Record Dates

First Submitted

November 17, 2022

First Posted

December 19, 2022

Study Start

June 8, 2023

Primary Completion

May 11, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

US(2)