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Clinical Trials/NCT05656560
NCT05656560
Active, not recruiting
Not Applicable

Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records

Northwestern University2 sites in 1 country786 target enrollmentJune 8, 2023
ConditionsPolypharmacy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Polypharmacy
Sponsor
Northwestern University
Enrollment
786
Locations
2
Primary Endpoint
The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure)
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 8, 2023
End Date
May 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephen Persell, MD, MPH

Professor; Director, Center for Primary Care Innovation

Northwestern University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure)

Time Frame: 18 months

The composite of the 7 high-risk polypharmacy measures (Secondary outcomes #6-12)

Secondary Outcomes

  • The percentage of HRPP patients with Heart Failure-thiazolidinedione interaction(18 months)
  • The percentage of HRPP patients with CKD-NSAID interaction(18 months)
  • The rate of Emergency Department visits per patient -all cause(18 months)
  • The rate of hospital admissions per patient-all cause(18 months)
  • The percentage of HRPP patients with a fall condition-drug interaction(18 months)
  • The percentage of HRPP patients with Heart failure with reduced ejection fraction- non-dihydropyridine calcium channel blocker interaction(18 months)
  • The percentage of HRPP patients with CKD-glyburide/glimepiride interaction(18 months)
  • The rate of Emergency Department visits per patient-Adverse drug event (ADE)-specific(18 months)
  • The percentage of HRPP patients with Heart failure-NSAID interaction(18 months)
  • The rate of hospital admissions per patient-ADE-specific(18 months)
  • The percentage of HRPP patients with a fall drug-drug interaction(18 months)

Study Sites (2)

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