UCLA Health
Los Angeles, California, 90095, United States
NCT Number: NCT04851691
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90095, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Patients will receive usual care from their physicians.
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
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
Time frame: 90 days
Number of patients with at least one emergency department visit within 90 days of being exposed to the intervention
Time frame: 90 days
Number of patients with at least one hospitalization within 90 days of being exposed to the intervention
Time frame: 90 days
Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention
Time frame: 90 days
Death within 90 days after enrollment
University of California, Los Angeles
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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