Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial

Polypharmacy Clinical Trial

— HRPP  

Official title:

Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05656560
• Other study ID #: STU00213231
• Secondary ID: R01AG070054
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Polypharmacy

Intervention

Behavioral:
• Clinical decision support (CDS)-Commitment nudge
EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy

Other:
• Clinician education
Brief, online education module for primary care clinicians

Behavioral:
• Clinical decision support (CDS)-Justification nudge
EHR clinical decision support alerts-clinician rational for high risk polypharmacy

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Northwestern University	National Institute on Aging (NIA), University of California, Los Angeles, University of Pittsburgh Medical Center, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The percentage of HRPP patients with a hospitalization or emergency department (ED) visit for seizure.	Safety measure for discontinuing or reducing benzodiazepines and anticonvulsants	18 months
Other	The percentage of HRPP patients with a hospitalization or ED visit for pain.	Safety measure for discontinuing or reducing tricyclic antidepressants, gabapentinoids, serotonin and norepinephrine reuptake inhibitors, opioids, and NSAIDs	18 months
Other	The percentage of HRPP patients with a hospitalization or ED visit for depression or suicidality	Safety measure for discontinuing or reducing tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors and selective serotonin reuptake inhibitors	18 months
Other	The percentage of HRPP patients with a hospitalization or ED visit for anxiety.	Safety measure for discontinuing or reducing benzodiazepines, serotonin and norepinephrine reuptake inhibitors and selective serotonin reuptake inhibitors	18 months
Other	The percentage of HRPP patients with a hospitalization or ED visit for sedative withdrawal.	Safety measure for discontinuing or reducing benzodiazepines and Z-drugs (GABA receptor modulators)	18 months
Other	The percentage of HRPP patients with a hospitalization or ED visit for opioid withdrawal.	Safety measure for discontinuing or reducing opioids	18 months
Other	The percentage of HRPP patients with a hospitalization or ED visit for behavioral disturbance in dementia or psychosis.	Safety measure for discontinuing or reducing antipsychotics	18 months
Other	The percentage of HRPP patients with a hospitalization or ED visit for hyperglycemia.	Safety measure for discontinuing or reducing glyburide, glimepiride, and thiazolidinediones	18 months
Other	The percentage of HRPP patients with a hospitalization or ED visit for tachycardia (other than ventricular) or hypertensive emergency.	Safety measure for discontinuing or reducing non-dihydropyridine calcium channel blockers	18 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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