Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial

Study Overview
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Brief Summary
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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.

Official Title
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Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records

Conditions
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Polypharmacy

Intervention / Treatment
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* Behavioral: Clinical decision support (CDS)-Commitment nudge
* Other: Clinician education
* Behavioral: Clinical decision support (CDS)-Justification nudge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Northwestern Medicine or UPMC primary care clinic: Internal Medicine, Family Medicine, or General Practice or Geriatrics Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clinician education only<br>Online clinician education | Other: Clinician education<br>* Brief, online education module for primary care clinicians<br>|
| Experimental: Commitment nudge<br>The commitment nudge will be an EHR alert that is triggered when a clinician renews or orders a qualifying medication in any Epic encounter (including non-face-to-face encounters) for a patient aged 65 or greater who meets criteria for high-risk polypharmacy. When triggered, the commitment nudge will offer the clinician a choice option that sets a reminder to discuss polypharmacy at the patient's next visit date. | Behavioral: Clinical decision support (CDS)-Commitment nudge<br>* EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy<br>* Other names: Commitment nudge;Other: Clinician education<br>* Brief, online education module for primary care clinicians<br>|
| Experimental: Justification nudge<br>The justification nudge will be an EHR alert triggered for patients with high-risk polypharmacy when a clinician begins to renew or newly prescribe a medication that causes a high-risk criterion to be fulfilled (i.e., a medication meeting causing 1 of the 7 high-risk polypharmacy criteria/primary study measures to be met). This alert will inform the clinician of the high-risk nature of the prescription and request a free-text justification for starting or renewing the medication. This written justification will appear in the EHR in a section of that encounter that other EHR users can see. | Other: Clinician education<br>* Brief, online education module for primary care clinicians<br>Behavioral: Clinical decision support (CDS)-Justification nudge<br>* EHR clinical decision support alerts-clinician rational for high risk polypharmacy<br>* Other names: Justification nudge;|
| Experimental: Commitment nudge + Justification nudge<br>This study arm will receive both the commitment nudge and the justification nudge. | Behavioral: Clinical decision support (CDS)-Commitment nudge<br>* EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy<br>* Other names: Commitment nudge;Other: Clinician education<br>* Brief, online education module for primary care clinicians<br>Behavioral: Clinical decision support (CDS)-Justification nudge<br>* EHR clinical decision support alerts-clinician rational for high risk polypharmacy<br>* Other names: Justification nudge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure) | The composite of the 7 high-risk polypharmacy measures (Secondary outcomes #6-12) | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of Emergency Department visits per patient -all cause | Denominator: All older adults with HRPP. Numerator: Patients with an emergency department encounter during the look back period. | 18 months | 
| The rate of Emergency Department visits per patient-Adverse drug event (ADE)-specific | Denominator: All older adults with HRPP. Numerator: Patients with an emergency department encounter for ADE during the look back period. | 18 months | 
| The rate of hospital admissions per patient-all cause | Denominator: All older adults with HRPP. Numerator: Patients with an inpatient admission for any reason during the look back period. | 18 months | 
| The rate of hospital admissions per patient-ADE-specific | Denominator: All older adults with HRPP. Numerator: Patients with an inpatient admission for ADE during the look back period. | 18 months | 
| The percentage of HRPP patients with a fall condition-drug interaction | Denominator: All older adult patients with HRPP with a fall marker. Numerator: Patients with an active eligible fall risk medication on medication list. | 18 months | 
| The percentage of HRPP patients with a fall drug-drug interaction | Denominator: All older adult patients with HRPP. Numerator: Patients with greater than or equal to 3 active eligible fall risk medications. | 18 months | 
| The percentage of HRPP patients with Heart failure-NSAID interaction | Denominator: All older adult patients with HRPP with a CHF marker. Numerator: Patients with an active eligible NSAID medication. | 18 months | 
| The percentage of HRPP patients with Heart Failure-thiazolidinedione interaction | Denominator: All older adults with HRPP with a CHF marker. Numerator: Patients with an active eligible thiazolidinedione medication. | 18 months | 
| The percentage of HRPP patients with Heart failure with reduced ejection fraction- non-dihydropyridine calcium channel blocker interaction | Denominator: All older adults with HRPP with CHFlowEF marker. Numerator: Patients with an active eligible calcium channel blocker medication. | 18 months | 
| The percentage of HRPP patients with CKD-glyburide/glimepiride interaction | Denominator: All older adults with HRPP with most-recent eGFR <60. Numerator: Patients with an active eligible glyburide-containing medication. | 18 months | 
| The percentage of HRPP patients with CKD-NSAID interaction | Denominator: All older adults with HRPP with most-recent eGFR < 30. Numerator: Patients with an active eligible NSAID medication. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical decision support, electronic health record, behavioral economics, high-risk geriatric polypharmacy