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

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Northwestern University

Status

Active, not recruiting

Conditions

Polypharmacy

Treatments

Other: Clinician education
Behavioral: Clinical decision support (CDS)-Commitment nudge
Behavioral: Clinical decision support (CDS)-Justification nudge

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05656560
R01AG070054 (U.S. NIH Grant/Contract)
STU00213231

Details and patient eligibility

About

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.

Enrollment

786 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • None

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

786 participants in 4 patient groups

Clinician education only
Other group
Description:
Online clinician education
Treatment:
Other: Clinician education
Commitment nudge
Experimental group
Description:
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.
Treatment:
Behavioral: Clinical decision support (CDS)-Commitment nudge
Other: Clinician education
Justification nudge
Experimental group
Description:
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.
Treatment:
Behavioral: Clinical decision support (CDS)-Justification nudge
Other: Clinician education
Commitment nudge + Justification nudge
Experimental group
Description:
This study arm will receive both the commitment nudge and the justification nudge.
Treatment:
Behavioral: Clinical decision support (CDS)-Justification nudge
Behavioral: Clinical decision support (CDS)-Commitment nudge
Other: Clinician education

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Stephen D Persell, MD, MPH; Tiffany Brown, MPH

Data sourced from clinicaltrials.gov

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