An Electronic Clinical Decision Support Tool to Reduce Low-value Antipsychotic Prescriptions

January 18, 2024 updated by: Catherine A. Sarkisian, University of California, Los Angeles

A Pragmatic Randomized-controlled Trial of a Multi-pronged Electronic Health Record-based Clinical Decision Support Tool to Reduce Low-value Antipsychotic Prescriptions Among Older Adults With Alzheimer's and Related Dementias

The goal of this study will be to design, implement and test the impact of a quality improvement (QI) intervention that uses an EHR CDS tool among physicians newly ordering an antipsychotic medication for older adults with ADRD. The study team hypothesizes that the intervention will reduce each participating clinician's pill days per patient prescribed.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Importance: Among patients with Alzheimer's disease and its related dementias (ADRD) with behavioral disturbances, antipsychotic prescriptions have limited efficacy and substantially increase risk of death. Despite an FDA 2005 "black box" warning and multiple professional physician society guidelines discouraging their use, physicians continue to frequently prescribe antipsychotic medications as first-line therapy for behavioral disturbances among patients with ADRD.

Objective: This study will measure the impact of a multi-pronged electronic health record (EHR) clinical decision support (CDS) tool intervention to reduce physician prescriptions of new antipsychotic medications among older adults with ADRD.

Design, Setting, and Participants: Utilizing a pragmatic parallel cluster-randomized trial design, the study will randomize eligible physicians from a large urban academic medical center to either receive an EHR CDS tool (intervention) or not (control) when they prescribe a new antipsychotic medication during a visit with a patient with ADRD. The intervention will include three components: (1) alerts the prescriber that antipsychotic prescriptions increase mortality; (2) offers non-pharmacological behavioral resources for caregivers; and if the prescriber does not cancel the order (3) auto-defaults the prescription to contain the lowest dose and number of pills (n=30) without refills. In addition, the PI will email all providers randomized to the intervention arm in order to make them aware of the components of this intervention and its motivation. Acknowledging the clinical complexity of this vulnerable patient population, the multidisciplinary study team attempted to design the intervention to maximize impact while minimizing clinician burden. Over a one-year timeframe, the study team will compare the cumulative total of new antipsychotic pill-days prescribed (primary outcome) by physicians in the intervention group versus in the control group.

Hypothesis: This pragmatic trial will advance understanding of how a multi-pronged EHR CDS tool can potentially reduce harmful, low-value care among older adults with ADRD.

Study Type

Interventional

Enrollment (Estimated)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Physicians who will be eligible to receive the EHR CDS tool intervention include those who provide ambulatory care in the UCLA health system and have newly prescribed antipsychotics (e.g., Quetiepine, Olanzapine, Risperidone, Aripiprazole, Haloperidol, Clozapine) for eligible patients (described below) at the medical center in the last 24 months.
  • Eligible patients will be enrolled in the study during their first encounter with one of the randomized physicians (see above) during which a new antipsychotic medication order will be initiated. Inclusion criteria for patients will include: 1) having an assigned primary care physician (PCP) and/or assignment to an Accountable Care Organization (ACO) at UCLA Health, and: 2) being part of the health system's EHR-based dementia registry.

Exclusion Criteria:

  • Patients who have diagnosis codes for schizophrenic disorders, delusion disorders, bipolar disorders, or other non-organic psychoses on their problem list.
  • Patients with Parkinson's disease on their problem list
  • Patients who have been prescribed antipsychotics in the prior 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EHR CDS tool
Multi-pronged electronic health record (EHR) clinical decision support (CDS) tool intervention to reduce physician prescriptions of new antipsychotic medications among older adults with ADRD
Behavioral: EHR CDS
When a clinician initiates a new antipsychotic prescription for a patient with dementia, a three-pronged electronic health record clinical decision support tool "pops up": (1) Alerting clinicians that antipsychotic prescriptions increase patient mortality; (2) Offering non-pharmacological behavioral resources for caregivers via a link to the IDEA! strategy resources on how caregivers can best manage a patient's behavioral disturbance non-pharmacologically, which will be available in the EHR to include in the patient's after visit summary; and (3) Defaulting prescriptions to a low supply of pills in to order to minimize harm. In addition, the PI will email all providers randomized to the intervention arm in order to make them aware of the components of this intervention and its motivation.
Experimental: Control
Physicians will not receive intervention and perform duties as usual.
Other: Usual Care
Patients will receive usual care from their physicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative total of new antipsychotic pill-days prescribed
Time Frame: 12 month time point
Cumulative total of new antipsychotic prescription days supplied by clinicians per eligible patient in the 12 months after the intervention rollout date compared to the prior 12-months
12 month time point

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who receive handout
Time Frame: 12 month time point
Number of patients who receive the non-Pharmacologic IDEA Strategy handout at 12 month time point comparing the intervention vs. control
12 month time point
Number of patients with ER visit
Time Frame: 90 days
Number of patients with at least one emergency department visit within 90 days of being exposed to the intervention
90 days
Number of patients with hospitalization
Time Frame: 90 days
Number of patients with at least one hospitalization within 90 days of being exposed to the intervention
90 days
Hospitalizations (including psychiatric hospitalizations)
Time Frame: 90 days
Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention
90 days
Death within 90 days after enrollment
Time Frame: 90 days
Death within 90 days after enrollment
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Catherine A Sarkisian, MD, MSPH, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2021

Primary Completion (Actual)

April 11, 2023

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

April 2, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AG059815-01S1 (U.S. NIH Grant/Contract)
  • 1R01AG059815-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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