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

Sponsor

Northwestern University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05656560

Collaborator

National Institute on Aging (NIA) (NIH), University of Pittsburgh Medical Center (Other), University of Southern California (Other), University of California, Los Angeles (Other)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polypharmacy	Behavioral: Clinical decision support (CDS)-Commitment nudge Other: Clinician education Behavioral: Clinical decision support (CDS)-Justification nudge	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

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.	Behavioral: Clinical decision support (CDS)-Commitment nudge EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy Other Names: Commitment nudge Other: Clinician education Brief, online education module for primary care clinicians
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.	Behavioral: Clinical decision support (CDS)-Commitment nudge EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy Other Names: Commitment nudge 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

Outcome Measures

Primary Outcome Measures

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

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 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 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 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 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 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.
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 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 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 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.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Northwestern University
National Institute on Aging (NIA)
University of Pittsburgh Medical Center
University of Southern California
University of California, Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stephen Persell, MD, MPH, Professor; Director, Center for Primary Care Innovation, Northwestern University

ClinicalTrials.gov Identifier:

NCT05656560

Other Study ID Numbers:

STU00213231
R01AG070054

First Posted:

Dec 19, 2022

Last Update Posted:

Dec 19, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Stephen Persell, MD, MPH, Professor; Director, Center for Primary Care Innovation, Northwestern University

clinical decision support

electronic health record

behavioral economics

high-risk geriatric polypharmacy

Study Results

No Results Posted as of Dec 19, 2022