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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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