Trial Outcomes & Findings for An Electronic Clinical Decision Support Tool to Reduce Low-value Antipsychotic Prescriptions (NCT NCT04851691)

NCT ID: NCT04851691

Last Updated: 2024-09-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

158 participants

Primary outcome timeframe

12 month time point

Results posted on

2024-09-19

Participant Flow

Patients were enrolled into the study when an eligible provider initiated a new antipsychotic prescription (e.g., Quetiapine, Olanzapine, Risperidone, Aripiprazole, Haloperidol, Clozapine) during a patient visit. Eligible providers were assigned an arm of the study based on their 2019 new antipsychotic orders for this population. Patients were enrolled into each arm based on the providers arm assignment. Healthcare Providers were not enrolled in the study.

Participant milestones

Participant milestones
Measure
EHR CDS Tool
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the EHR CDS tool. The 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.
Control
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the control. Usual Care: Patients will receive usual care from their physicians.
Overall Study
STARTED
67
91
Overall Study
COMPLETED
67
91
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
EHR CDS Tool
n=67 Participants
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the 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 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.
Control
n=91 Participants
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the control. Physicians will not receive intervention and perform duties as usual. Usual Care: Patients will receive usual care from their physicians.
Total
n=158 Participants
Total of all reporting groups
Age, Continuous
81.19 years
STANDARD_DEVIATION 15.14 • n=5 Participants
84.78 years
STANDARD_DEVIATION 11.77 • n=7 Participants
83.26 years
STANDARD_DEVIATION 11.73 • n=5 Participants
Sex: Female, Male
Female
41 Participants
n=5 Participants
65 Participants
n=7 Participants
106 Participants
n=5 Participants
Sex: Female, Male
Male
26 Participants
n=5 Participants
26 Participants
n=7 Participants
52 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
52 Participants
n=5 Participants
70 Participants
n=7 Participants
122 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=5 Participants
10 Participants
n=7 Participants
16 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
9 Participants
n=5 Participants
11 Participants
n=7 Participants
20 Participants
n=5 Participants
Race/Ethnicity, Customized
Race Category · Asian
5 Participants
n=5 Participants
7 Participants
n=7 Participants
12 Participants
n=5 Participants
Race/Ethnicity, Customized
Race Category · Other Race
3 Participants
n=5 Participants
7 Participants
n=7 Participants
10 Participants
n=5 Participants
Race/Ethnicity, Customized
Race Category · White
45 Participants
n=5 Participants
63 Participants
n=7 Participants
108 Participants
n=5 Participants
Race/Ethnicity, Customized
Race Category · Unknown or Not Reported
8 Participants
n=5 Participants
11 Participants
n=7 Participants
19 Participants
n=5 Participants
Race/Ethnicity, Customized
Race Category · Black or African American
5 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants
Race/Ethnicity, Customized
Race Category · American Indian or Alaska Native
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 month time point

Population: Patients that received a new antipsychotic prescription (e.g., Quetiapine, Olanzapine, Risperidone, Aripiprazole, Haloperidol, Clozapine) from an eligible provider.

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

Outcome measures

Outcome measures
Measure
EHR CDS Tool
n=67 Participants
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the 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 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.
Control
n=91 Participants
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the control. Physicians will not receive intervention and perform duties as usual. Usual Care: Patients will receive usual care from their physicians.
Cumulative Total of New Antipsychotic Pill-days Prescribed
12569 New antipsychotic prescription days
25916 New antipsychotic prescription days

SECONDARY outcome

Timeframe: 12 month time point

Population: All participants enrolled in the study were eligible to receive the non-Pharmacologic IDEA Strategy handout

Number of patients who receive the non-Pharmacologic IDEA Strategy handout at 12 month time point comparing the intervention vs. control

Outcome measures

Outcome measures
Measure
EHR CDS Tool
n=67 Participants
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the 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 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.
Control
n=91 Participants
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the control. Physicians will not receive intervention and perform duties as usual. Usual Care: Patients will receive usual care from their physicians.
Number of Patients Who Receive Handout
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 90 days

Number of patients with at least one emergency department visit within 90 days of being exposed to the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Number of patients with at least one hospitalization within 90 days of being exposed to the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 days

Death within 90 days after enrollment

Outcome measures

Outcome data not reported

Adverse Events

EHR CDS Tool

Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths

Control

Serious events: 12 serious events
Other events: 6 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
EHR CDS Tool
n=67 participants at risk
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the 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 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.
Control
n=91 participants at risk
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the control. Physicians will not receive intervention and perform duties as usual. Usual Care: Patients will receive usual care from their physicians.
General disorders
Inpatient Admission
3.0%
2/67 • Participants were tracked for adverse events 3 months after their first encounter with a randomized physician during which a new antipsychotic medication order is initiated.
An adverse event is defined as an Emergency Department visit that did not require hospitalization. Serious adverse events include hospitalization or death. Providers were not assessed for adverse events
13.2%
12/91 • Participants were tracked for adverse events 3 months after their first encounter with a randomized physician during which a new antipsychotic medication order is initiated.
An adverse event is defined as an Emergency Department visit that did not require hospitalization. Serious adverse events include hospitalization or death. Providers were not assessed for adverse events

Other adverse events

Other adverse events
Measure
EHR CDS Tool
n=67 participants at risk
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the 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 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.
Control
n=91 participants at risk
Patients with an encounter in which the physician attempts to place an order for a new antipsychotic prescription. Physician has been assigned to the control. Physicians will not receive intervention and perform duties as usual. Usual Care: Patients will receive usual care from their physicians.
General disorders
Emergency Department visits that did not require admissions
6.0%
4/67 • Participants were tracked for adverse events 3 months after their first encounter with a randomized physician during which a new antipsychotic medication order is initiated.
An adverse event is defined as an Emergency Department visit that did not require hospitalization. Serious adverse events include hospitalization or death. Providers were not assessed for adverse events
6.6%
6/91 • Participants were tracked for adverse events 3 months after their first encounter with a randomized physician during which a new antipsychotic medication order is initiated.
An adverse event is defined as an Emergency Department visit that did not require hospitalization. Serious adverse events include hospitalization or death. Providers were not assessed for adverse events

Additional Information

Project Manager

University of California Los Angeles, Division of General Internal Medicine and Health Services Research

Phone: 310-825-8253

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place