An Electronic Clinical Decision Support Tool to Reduce Low-value Antipsychotic Prescriptions
Primary Purpose
Alzheimer Disease, Dementia Alzheimers, Dementia of Alzheimer Type
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EHR CDS
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Alzheimer Disease focused on measuring Low Value Care, Antipsychotic medication
Eligibility Criteria
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
Sites / Locations
- UCLA Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
EHR CDS tool
Control
Arm Description
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
Physicians will not receive intervention and perform duties as usual.
Outcomes
Primary Outcome Measures
Cumulative total of new antipsychotic pill-days prescribed
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
Secondary Outcome Measures
Number of patients who receive handout
Number of patients who receive the non-Pharmacologic IDEA Strategy handout at 12 month time point comparing the intervention vs. control
Number of patients with ER visit
Number of patients with at least one emergency department visit within 90 days of being exposed to the intervention
Number of patients with hospitalization
Number of patients with at least one hospitalization within 90 days of being exposed to the intervention
Hospitalizations (including psychiatric hospitalizations)
Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention
Death within 90 days after enrollment
Death within 90 days after enrollment
Full Information
NCT ID
NCT04851691
First Posted
April 2, 2021
Last Updated
May 16, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04851691
Brief Title
An Electronic Clinical Decision Support Tool to Reduce Low-value Antipsychotic Prescriptions
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
April 11, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia Alzheimers, Dementia of Alzheimer Type
Keywords
Low Value Care, Antipsychotic medication
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
117 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EHR CDS tool
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Experimental
Arm Description
Physicians will not receive intervention and perform duties as usual.
Intervention Type
Behavioral
Intervention Name(s)
EHR CDS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patients will receive usual care from their physicians.
Primary Outcome Measure Information:
Title
Cumulative total of new antipsychotic pill-days prescribed
Description
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
Time Frame
12 month time point
Secondary Outcome Measure Information:
Title
Number of patients who receive handout
Description
Number of patients who receive the non-Pharmacologic IDEA Strategy handout at 12 month time point comparing the intervention vs. control
Time Frame
12 month time point
Title
Number of patients with ER visit
Description
Number of patients with at least one emergency department visit within 90 days of being exposed to the intervention
Time Frame
90 days
Title
Number of patients with hospitalization
Description
Number of patients with at least one hospitalization within 90 days of being exposed to the intervention
Time Frame
90 days
Title
Hospitalizations (including psychiatric hospitalizations)
Description
Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention
Time Frame
90 days
Title
Death within 90 days after enrollment
Description
Death within 90 days after enrollment
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine A Sarkisian, MD, MSPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
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An Electronic Clinical Decision Support Tool to Reduce Low-value Antipsychotic Prescriptions
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