Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Catherine Sarkisian (ucla)
Headshot of Catherine Sarkisian
Catherine Sarkisian

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Alzheimer Disease, Dementia Alzheimers, Dementia of Alzheimer Type, Low Value Care, Antipsychotic medication, Dementia, EHR CDS, EHR CDS tool

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Location

  • UCLA Health
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

  • Catherine Sarkisian (ucla)
    Dr. Catherine Sarkisian is a geriatrician and NIH-funded research scientist. Since early in her training she has committed her career to improving quality of life among vulnerable older adults. Most of her work has focused on implementing and evaluating academic-community partnered interventions and more recently, academic-health-system partnered pragmatic trials.

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04851691
Study Type
Interventional
Participants
Expecting 117 study participants
Last Updated