Skip to content

Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial

Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05656560
Acronym
HRPP
Enrollment
786
Registered
2022-12-19
Start date
2023-06-08
Completion date
2027-05-31
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polypharmacy

Keywords

clinical decision support, electronic health record, behavioral economics, high-risk geriatric polypharmacy

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.

Interventions

BEHAVIORALClinical decision support (CDS)-Commitment nudge

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

OTHERClinician education

Brief, online education module for primary care clinicians

BEHAVIORALClinical decision support (CDS)-Justification nudge

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure)18 monthsThe composite of the 7 high-risk polypharmacy measures (Secondary outcomes #6-12)

Secondary

MeasureTime frameDescription
The rate of Emergency Department visits per patient -all cause18 monthsDenominator: 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)-specific18 monthsDenominator: 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 cause18 monthsDenominator: 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-specific18 monthsDenominator: 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 interaction18 monthsDenominator: 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 interaction18 monthsDenominator: 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 interaction18 monthsDenominator: 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 interaction18 monthsDenominator: 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 interaction18 monthsDenominator: 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 interaction18 monthsDenominator: 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 interaction18 monthsDenominator: All older adults with HRPP with most-recent eGFR \< 30. Numerator: Patients with an active eligible NSAID medication.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026