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

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RanD

Status

Withdrawn

Conditions

Chronic Kidney Failure
Adverse Drug Event
Fall
Congestive Heart Failure

Treatments

Behavioral: Commitment nudge
Behavioral: Justification nudge

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03791580
STU00207210
R21AG057396 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • none

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

0 participants in 4 patient groups

Commitment nudge
Experimental group
Description:
Primary care clinicians in the practice assigned to this arm will receive only the commitment nudge.
Treatment:
Behavioral: Commitment nudge
Justification nudge
Experimental group
Description:
Primary care clinicians in the practice assigned to this arm will receive only the justification nudge.
Treatment:
Behavioral: Justification nudge
Commitment + Justification nudges
Experimental group
Description:
Primary care clinicians in the practice assigned to this arm will receive both the commitment nudge and the justification nudge.
Treatment:
Behavioral: Justification nudge
Behavioral: Commitment nudge
Non-participating
No Intervention group
Description:
Primary care clinicians in Northwestern-affiliated practices other than the 3 pilot-participating practices will not receive any study interventions.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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