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NCT Number: NCT05656560

Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Polypharmacy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medicine, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Clinical decision support (CDS)-Commitment nudge

Behavioral

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

Other names: Commitment nudge

Clinician education

Other

Brief, online education module for primary care clinicians

Clinical decision support (CDS)-Justification nudge

Behavioral

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

Other names: Justification nudge

Primary outcomes

  1. 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

  1. The rate of Emergency Department visits per patient -all cause

    Time frame: 18 months

    Denominator: All older adults with HRPP. Numerator: Patients with an emergency department encounter during the look back period.

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

    Time frame: 18 months

    Denominator: All older adults with HRPP. Numerator: Patients with an emergency department encounter for ADE during the look back period.

  3. The rate of hospital admissions per patient-all cause

    Time frame: 18 months

    Denominator: All older adults with HRPP. Numerator: Patients with an inpatient admission for any reason during the look back period.

  4. The rate of hospital admissions per patient-ADE-specific

    Time frame: 18 months

    Denominator: All older adults with HRPP. Numerator: Patients with an inpatient admission for ADE during the look back period.

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

    Time frame: 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.

  6. The percentage of HRPP patients with a fall drug-drug interaction

    Time frame: 18 months

    Denominator: All older adult patients with HRPP. Numerator: Patients with greater than or equal to 3 active eligible fall risk medications.

  7. The percentage of HRPP patients with Heart failure-NSAID interaction

    Time frame: 18 months

    Denominator: All older adult patients with HRPP with a CHF marker. Numerator: Patients with an active eligible NSAID medication.

  8. The percentage of HRPP patients with Heart Failure-thiazolidinedione interaction

    Time frame: 18 months

    Denominator: All older adults with HRPP with a CHF marker. Numerator: Patients with an active eligible thiazolidinedione medication.

  9. The percentage of HRPP patients with Heart failure with reduced ejection fraction- non-dihydropyridine calcium channel blocker interaction

    Time frame: 18 months

    Denominator: All older adults with HRPP with CHFlowEF marker. Numerator: Patients with an active eligible calcium channel blocker medication.

  10. The percentage of HRPP patients with CKD-glyburide/glimepiride interaction

    Time frame: 18 months

    Denominator: All older adults with HRPP with most-recent eGFR <60. Numerator: Patients with an active eligible glyburide-containing medication.

  11. The percentage of HRPP patients with CKD-NSAID interaction

    Time frame: 18 months

    Denominator: All older adults with HRPP with most-recent eGFR < 30. Numerator: Patients with an active eligible NSAID medication.

Other outcomes

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

    Time frame: 18 months

    Safety measure for discontinuing or reducing benzodiazepines and anticonvulsants

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

    Time frame: 18 months

    Safety measure for discontinuing or reducing tricyclic antidepressants, gabapentinoids, serotonin and norepinephrine reuptake inhibitors, opioids, and NSAIDs

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

    Time frame: 18 months

    Safety measure for discontinuing or reducing tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors and selective serotonin reuptake inhibitors

  4. The percentage of HRPP patients with a hospitalization or ED visit for anxiety.

    Time frame: 18 months

    Safety measure for discontinuing or reducing benzodiazepines, serotonin and norepinephrine reuptake inhibitors and selective serotonin reuptake inhibitors

  5. The percentage of HRPP patients with a hospitalization or ED visit for sedative withdrawal.

    Time frame: 18 months

    Safety measure for discontinuing or reducing benzodiazepines and Z-drugs (GABA receptor modulators)

  6. The percentage of HRPP patients with a hospitalization or ED visit for opioid withdrawal.

    Time frame: 18 months

    Safety measure for discontinuing or reducing opioids

  7. The percentage of HRPP patients with a hospitalization or ED visit for behavioral disturbance in dementia or psychosis.

    Time frame: 18 months

    Safety measure for discontinuing or reducing antipsychotics

  8. The percentage of HRPP patients with a hospitalization or ED visit for hyperglycemia.

    Time frame: 18 months

    Safety measure for discontinuing or reducing glyburide, glimepiride, and thiazolidinediones

  9. The percentage of HRPP patients with a hospitalization or ED visit for tachycardia (other than ventricular) or hypertensive emergency.

    Time frame: 18 months

    Safety measure for discontinuing or reducing non-dihydropyridine calcium channel blockers

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

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

Registry information

Official study title

Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records

Acronym: HRPP

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 19, 2022
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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