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

Not Applicable

• Conditions: Fall; Chronic Kidney Failure; Congestive Heart Failure; Adverse Drug Event
• Interventions: Behavioral: Commitment nudge; Behavioral: Justification nudge

• Registration Number: NCT03791580
• Lead Sponsor: RAND

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.

Study Timeline

• Study First Submitted: 2018-12-29
• Study First Submitted QC: 2018-12-29
• Study First Posted: 2019-01-02
• Study Start: 2019-02-11
• Status Verified: 2019-06
• Primary Completion: 2019-06-01
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-13
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Commitment + Justification nudges	Commitment nudge	Primary care clinicians in the practice assigned to this arm will receive both the commitment nudge and the justification nudge.
Commitment nudge	Commitment nudge	Primary care clinicians in the practice assigned to this arm will receive only the commitment nudge.
Justification nudge	Justification nudge	Primary care clinicians in the practice assigned to this arm will receive only the justification nudge.
Commitment + Justification nudges	Justification nudge	Primary care clinicians in the practice assigned to this arm will receive both the commitment nudge and the justification nudge.

Primary Outcome Measures

Name	Time	Method
High-risk polypharmacy criterion: CKD-glyburide/glimepiride interaction	28 months	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.
High-risk polypharmacy criterion: CHF-thiazolidinedione interaction	28 months	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.
High-risk polypharmacy criterion: Fall condition-drug interaction	28 months	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.
High-risk polypharmacy criterion: CHF-NSAID interaction	28 months	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.
High-risk polypharmacy criterion: CHF-non-dihydropyridine calcium channel blocker interaction	28 months	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.
High-risk polypharmacy criterion: Fall drug-drug interaction	28 month	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.
High-risk polypharmacy criterion: CKD-NSAID interaction	28 months	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.

Trial Locations

Locations (1)

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States