Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase

NCT03791580 | Withdrawn

• 2 other identifiers: STU00207210R21AG057396
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Polypharmacy is common among older adults in the United States and is associated with harms such as adverse drug reactions and higher costs of care. This pilot-phase project is designed to test two electronic health record (EHR)-based behavioral economic nudges to help primary care clinicians reduce the rate of high-risk polypharmacy among their older adult patients.

Conditions

Fall; Congestive Heart Failure; Chronic Kidney Failure; Adverse Drug Event

Keywords

Polypharmacy; Primary Health Care; Economics, Behavioral; Deprescriptions; Decision Support Systems, Clinical; Electronic Health Records; Geriatrics

Outcome Measures

Primary Outcomes (7)

• High-risk polypharmacy criterion: Fall condition-drug interaction

  Denominator: count of patients aged \>=65 years AND who have \>=1 fall marker within the prior 2 years (ICD-10 codes for falls or hip fractures; OR who are recorded in the EHR as being high-risk for falls). Numerator: count of patients in the denominator who have 5+ medications in their EHR med list AND who have \>=1 medication in their EHR med list that is a tricyclic antidepressant, Z-drug (e.g., zolpidem), benzodiazepine, antipsychotic, anticonvulsant, SSRI/SNRI, or opioid.

  28 months

• High-risk polypharmacy criterion: Fall drug-drug interaction

  Denominator: count of patients aged \>=65 years. Numerator: count of patients in the denominator who have 5+ meds AND who have \>=3 medications in their EHR med list that are tricyclic antidepressants, Z-drugs (e.g., zolpidem), benzodiazepines, antipsychotics, anticonvulsants, SSRIs/SNRIs, or opioids.

  28 month

• High-risk polypharmacy criterion: CKD-glyburide/glimepiride interaction

  Denominator: count of patients aged \>=65 years AND who have most-recent estimated glomerular filtration rate (eGFR) \< 60 as estimated by the Cockcroft-Gault equation. Numerator: count of patients in the denominator who have 5+ meds AND glyburide or glimepiride in their EHR med list.

  28 months

• High-risk polypharmacy criterion: CKD-NSAID interaction

  Denominator: count of patients aged \>=65 years AND who have most-recent eGFR \< 30 as estimated by the Cockcroft-Gault equation. Numerator: count of patients in the denominator who have 5+ meds AND a systemically-absorbed non-steroidal anti-inflammatory drug (NSAID) in their EHR med list.

  28 months

• High-risk polypharmacy criterion: CHF-NSAID interaction

  Denominator: count of patients aged \>=65 years AND who have 5+ meds AND congestive heart failure (identified via ICD-10 code within prior 2 years). Numerator: count of patients in the denominator who have a systemically-absorbed non-steroidal anti-inflammatory drug (NSAID) in their EHR med list.

  28 months

• High-risk polypharmacy criterion: CHF-non-dihydropyridine calcium channel blocker interaction

  Denominator: count of patients aged \>=65 years AND who have low-ejection-fraction congestive heart failure (identified via ICD-10 code within prior 2 years). Numerator: count of patients in the denominator who have 5+ meds AND a non-dihydropyridine calcium channel blocker in their EHR med list.

  28 months

• High-risk polypharmacy criterion: CHF-thiazolidinedione interaction

  Denominator: count of patients aged \>=65 years AND who have low-ejection-fraction congestive heart failure (identified via ICD-10 code within prior 2 years). Numerator: count of patients in the denominator who have 5+ meds AND a thiazolidinedione in their EHR med list.

  28 months

Study Arms (4)

Commitment nudge

EXPERIMENTAL

Primary care clinicians in the practice assigned to this arm will receive only the commitment nudge.

Behavioral: Commitment nudge

Justification nudge

EXPERIMENTAL

Primary care clinicians in the practice assigned to this arm will receive only the justification nudge.

Behavioral: Justification nudge

Commitment + Justification nudges

EXPERIMENTAL

Primary care clinicians in the practice assigned to this arm will receive both the commitment nudge and the justification nudge.

Behavioral: Commitment nudge; Behavioral: Justification nudge

Non-participating

NO INTERVENTION

Primary care clinicians in Northwestern-affiliated practices other than the 3 pilot-participating practices will not receive any study interventions.

Interventions

Commitment nudge BEHAVIORAL

The commitment nudge will ask clinicians to commit to discussing high-risk polypharmacy at the next office visit with patients who have high-risk polypharmacy. Clinicians who commit will receive a reminder just before the next office visit begins. The patient will also receive notification of the commitment via EHR patient portal. This nudge will be operationalized via two sequential clinician-facing EHR best practice alerts (BPAs): the first at time of opening any encounter (including encounters other than a face-to-face office visit, e.g., medication refills), and the second (contingent on making a commitment to discuss high-risk polypharmacy) at time of opening the subsequent encounter for a face-to-face office visit. Each of these BPAs will describe the specific high-risk polypharmacy criterion (or criteria) the patient meets, the specific harms associated with the medication(s) triggering the criterion/criteria, and lower-risk alternative treatment strategies.

Commitment + Justification nudges; Commitment nudge

Justification nudge BEHAVIORAL

The justification nudge will ask clinicians who prescribe or renew a drug that meets high-risk polypharmacy criteria (in the context of the patient's other medications) to write a brief justification for prescribing this high-risk medication. This written justification will be recorded in the patient's medical record. The best practice alert requesting the justification will also describe the specific high-risk polypharmacy criterion (or criteria) the patient meets, the specific harms associated with the medication(s) triggering the criterion/criteria, and lower-risk alternative treatment strategies.

Commitment + Justification nudges; Justification nudge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care clinicians practicing in one of the participating Northwestern-affiliated practices

You may not qualify if:

• none

Sponsors & Collaborators

• University of California, Los Angeles: collaborator
• University of Southern California: collaborator
• University of Pittsburgh: collaborator
• National Institute on Aging (NIA): collaborator
• RAND: lead
• Northwestern University: collaborator

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Heart Failure; Kidney Failure, Chronic; Drug-Related Side Effects and Adverse Reactions; Behavior

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Study Officials

• Mark W Friedberg, MD, MPP

  RAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will randomly assign each of the 3 participating pilot practices to 1 of 3 arms: (1) commitment nudge, (2) justification nudge, or (3) both commitment and justification nudges. Randomization will be at the practice level, without replacement, thus assigning exactly 1 practice to each arm. All participating clinicians within a given practice will receive the same nudges. Northwestern-affiliated practices that do not participate in the pilot will constitute a fourth arm of this pilot study.

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: January 2, 2019
• Study Start: February 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)