Clinical trial NCT03791580: Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase
Official title: Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: University of California, Los Angeles
name: University of Southern California
name: University of Pittsburgh
name: National Institute on Aging (NIA)
First posted: 2019-01-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Polypharmacy increases the likelihood of being prescribed and harmed by high-risk medications. As noted in the 2014 National Action Plan for Adverse Drug Event (ADE) Prevention, polypharmacy both increases the likelihood of being prescribed high-risk medications and increases the likelihood that these high-risk medications will lead to adverse drug events. This pilot-phase study is intended to test clinicians' perceptions of EHR-based nudges designed to reduce high-risk polypharmacy among patients aged 65 years or more, thereby enabling investigators to refine the nudges, and to generate outcomes data that will inform power calculations for a subsequent larger study (the main study) of the nudges' effectiveness.

In this pilot-phase study, the investigators will deploy 2 EHR-based behavioral nudges (a commitment nudge and a justification nudge) among 18 or more primary care clinicians in 3 primary care practices (6 clinicians or more per practice) affiliated with Northwestern University for approximately 4 months. The 3 practices participating in the pilot will be a convenience sample of Northwestern-affiliated practices known to study investigators.

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.

The investigators will ask leaders of participating practices for their qualitative observations on how clinicians and patients experience the nudges (e.g., how the nudges affect workflows). The investigators also will collect data on the outcome measures before and during the approximately 4-month pilot period and compare these data to contemporaneous outcomes measures generated by Northwestern-affiliated practices that do not participate in the pilot.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: High-risk polypharmacy criterion: Fall condition-drug interaction
timeFrame: 28 months
measure: High-risk polypharmacy criterion: Fall drug-drug interaction
timeFrame: 28 month
measure: High-risk polypharmacy criterion: CKD-glyburide/glimepiride interaction
timeFrame: 28 months
measure: High-risk polypharmacy criterion: CKD-NSAID interaction
timeFrame: 28 months
measure: High-risk polypharmacy criterion: CHF-NSAID interaction
timeFrame: 28 months
measure: High-risk polypharmacy criterion: CHF-non-dihydropyridine calcium channel blocker interaction
timeFrame: 28 months
measure: High-risk polypharmacy criterion: CHF-thiazolidinedione interaction
timeFrame: 28 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: RAND
name: Mark W Friedberg, MD, MPP
role: PRINCIPAL_INVESTIGATOR
References: