Clinical trial NCT05656560: Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial
Official title: Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Polypharmacy
Keywords: clinical decision support
electronic health record
behavioral economics
high-risk geriatric polypharmacy
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of Pittsburgh Medical Center
name: University of Southern California
name: University of California, Los Angeles
First posted: 2022-12-19
Enrollment: 786
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure)
timeFrame: 18 months
Secondary outcomes:
measure: The rate of Emergency Department visits per patient -all cause
timeFrame: 18 months
measure: The rate of Emergency Department visits per patient-Adverse drug event (ADE)-specific
timeFrame: 18 months
measure: The rate of hospital admissions per patient-all cause
timeFrame: 18 months
measure: The rate of hospital admissions per patient-ADE-specific
timeFrame: 18 months
measure: The percentage of HRPP patients with a fall condition-drug interaction
timeFrame: 18 months
measure: The percentage of HRPP patients with a fall drug-drug interaction
timeFrame: 18 months
measure: The percentage of HRPP patients with Heart failure-NSAID interaction
timeFrame: 18 months
measure: The percentage of HRPP patients with Heart Failure-thiazolidinedione interaction
timeFrame: 18 months
measure: The percentage of HRPP patients with Heart failure with reduced ejection fraction- non-dihydropyridine calcium channel blocker interaction
timeFrame: 18 months
measure: The percentage of HRPP patients with CKD-glyburide/glimepiride interaction
timeFrame: 18 months
measure: The percentage of HRPP patients with CKD-NSAID interaction
timeFrame: 18 months
Other outcomes:
measure: The percentage of HRPP patients with a hospitalization or emergency department (ED) visit for seizure.
timeFrame: 18 months
measure: The percentage of HRPP patients with a hospitalization or ED visit for pain.
timeFrame: 18 months
measure: The percentage of HRPP patients with a hospitalization or ED visit for depression or suicidality
timeFrame: 18 months
measure: The percentage of HRPP patients with a hospitalization or ED visit for anxiety.
timeFrame: 18 months
measure: The percentage of HRPP patients with a hospitalization or ED visit for sedative withdrawal.
timeFrame: 18 months
measure: The percentage of HRPP patients with a hospitalization or ED visit for opioid withdrawal.
timeFrame: 18 months
measure: The percentage of HRPP patients with a hospitalization or ED visit for behavioral disturbance in dementia or psychosis.
timeFrame: 18 months
measure: The percentage of HRPP patients with a hospitalization or ED visit for hyperglycemia.
timeFrame: 18 months
measure: The percentage of HRPP patients with a hospitalization or ED visit for tachycardia (other than ventricular) or hypertensive emergency.
timeFrame: 18 months
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
References: