Alzheimer Disease, Dementia Alzheimers, Dementia of Alzheimer Type
Conditions
Keywords
Low Value Care, Antipsychotic medication
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.
Interventions
BEHAVIORALEHR 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.
OTHERUsual Care
Patients will receive usual care from their physicians.
Sponsors
National Institute on Aging (NIA)
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Total of New Antipsychotic Pill-days Prescribed | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Receive Handout | 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 |
| Number of Patients With ER Visit | 90 days | Number of patients with at least one emergency department visit within 90 days of being exposed to the intervention |
| Number of Patients With Hospitalization | 90 days | Number of patients with at least one hospitalization within 90 days of being exposed to the intervention |
| Hospitalizations (Including Psychiatric Hospitalizations) | 90 days | Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention |
| Death Within 90 Days After Enrollment | 90 days | Death within 90 days after enrollment |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 67 |
| 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.
Physicians will not receive intervention and perform duties as usual.
Usual Care: Patients will receive usual care from their physicians. | 91 |
| Total | 158 |
Baseline characteristics
| Characteristic | Control | Total | EHR CDS Tool |
|---|---|---|---|
| Age, Continuous | 84.78 years STANDARD_DEVIATION 11.77 | 83.26 years STANDARD_DEVIATION 11.73 | 81.19 years STANDARD_DEVIATION 15.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 70 Participants | 122 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 16 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 20 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Category American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Category Asian | 7 Participants | 12 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Category Black or African American | 3 Participants | 8 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Category Other Race | 7 Participants | 10 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Category Unknown or Not Reported | 11 Participants | 19 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Category White | 63 Participants | 108 Participants | 45 Participants |
| Sex: Female, Male Female | 65 Participants | 106 Participants | 41 Participants |
| Sex: Female, Male Male | 26 Participants | 52 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 67 | 2 / 91 |
| other Total, other adverse events | 4 / 67 | 6 / 91 |
| serious Total, serious adverse events | 2 / 67 | 12 / 91 |
Outcome results
Primary
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
Time frame: 12 month time point
Population: Patients that received a new antipsychotic prescription (e.g., Quetiapine, Olanzapine, Risperidone, Aripiprazole, Haloperidol, Clozapine) from an eligible provider.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EHR CDS Tool | Cumulative Total of New Antipsychotic Pill-days Prescribed | 12569 New antipsychotic prescription days |
| Control | Cumulative Total of New Antipsychotic Pill-days Prescribed | 25916 New antipsychotic prescription days |
Secondary
Death Within 90 Days After Enrollment
Death within 90 days after enrollment
Time frame: 90 days
Secondary
Hospitalizations (Including Psychiatric Hospitalizations)
Hospitalizations (including psychiatric hospitalizations) within 90 days of being exposed to the intervention
Time frame: 90 days
Secondary
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
Time frame: 12 month time point
Population: All participants enrolled in the study were eligible to receive the non-Pharmacologic IDEA Strategy handout
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EHR CDS Tool | Number of Patients Who Receive Handout | 0 Participants |
| Control | Number of Patients Who Receive Handout | 0 Participants |
Secondary
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
Time frame: 90 days
Secondary
Number of Patients With Hospitalization
Number of patients with at least one hospitalization within 90 days of being exposed to the intervention
Time frame: 90 days