This study tests the effectiveness of an intervention treatment algorithm vs. usual care control in a practical clinical trial. Control arm providers will receive a standard medication alert in the electronic medical record (EMR) when initiating an antipsychotic prescription for an eligible patient. Intervention arm prescribers will receive an interactive medication alert in the EMR when prescribing for eligible patients and the patient and provider will enter the treatment algorithm (provider - medication alert plus clinical review by a child psychiatrist; patient - offer of personalized behavioral health navigation plus bridging therapy when appropriate). The study aims to recruit 800 eligible patients in 4 health systems.
SUAY is a practical clinical trial designed to test the effectiveness of an intervention aiming to improve the targeted and safer use of antipsychotic medications by guiding clinician-prescribing behavior of antipsychotics for children aged ≥ 3 and \< 18 years and encouraging psychosocial therapy for eligible youth. The intervention includes a medication best practice alert in Epic, consultation with a child and adolescent psychiatrist, and extra support for patients and families to improve behavioral health service access. The trial will be conducted in 4 non-academic health systems. Each health system will randomize prescribers to one of two study arms, intervention and control. During patient encounters, entering an antipsychotic for a potentially eligible patient will cause either the control or intervention medication alert to fire in the electronic medical record. The control arm medication alert will point prescribing clinicians to relevant Choosing Wisely® recommendations. The intervention arm medication alert will inform prescribers that: 1. Antipsychotics are not recommended 1st line treatment for non-psychotic disorders; 2. A child and adolescent psychiatrist (CAP) will review antipsychotic usage by youth; 3. Expedited access to bridging therapy, behavior health navigation, and/or a proactive consultation with a CAP may be ordered. The intervention medication alert will point prescribing clinicians to both Choosing Wisely® recommendations and to SUAY clinical prescribing guidelines. SUAY guidelines were developed by a national expert consensus panel in a prior phase of the study. Analytic data will be collected from automated data sources at the health systems. The primary outcomes are percent of children ordered an antipsychotic medication at 6 months of follow up, and total person-months of antipsychotic orders placed for participants during the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
733
Simple text medication alert referencing Choosing Wisely guidelines.
Interactive medication alert referencing SUAY Clinical Guidelines and offering options to keep/remove orders for the antipsychotic, virtual CAP consult, BH navigation for the patient, and access to bridging therapy for the patient.
Kaiser Permanente Colorado Institute for Health Research
Aurora, Colorado, United States
Nationwide Children's Hospital / Partners for Kids
Columbus, Ohio, United States
Kaiser Permanente Center for Health Research - Northwest
Portland, Oregon, United States
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States
Percent of Youths With Antipsychotic Orders at 6 Months
Measured by medication orders placed within the health system
Time frame: 180 day period following index date
Days' Supply of Antipsychotics Ordered for Youth
Average days' supply of antipsychotic medication (values fell between 1 and 180 days), as measured by the intended days' supply on the medication orders for each participant. Only orders placed within the health system were accounted for.
Time frame: 180 day period following index date
Percent of Youths Using Antipsychotics at 6 Months
Measured by medication fill data available to the health system
Time frame: 180 day period following index date
Days' Supply of Antipsychotic Use by Youth
Average days' supply of antipsychotic medication (values fell between 1 and 180 days), as measured by medication fill data available to the health system for each participant. Only pharmacy claims captured by the health system were accounted for.
Time frame: 180 day period following index date
Emergency Department/Urgent Care Visit Frequency
Measured by utilization data; both for psychiatric crises and for all other reasons
Time frame: 180 day period following index date
Baseline and Follow-up Safety Assessments - BMI
Percentage of patients with BMI measurements completed at baseline and 3 months
Time frame: index date to 180 days post-index date
Change to Psychotropic Medication Treatment Plan
Percentage of patients with change to psychotropic medication treatment plan following exposure to study algorithm
Time frame: 180 day period following index date
Behavioral Health (BH) Navigation Acceptance
Percent of intervention arm patients that agree to BH navigation
Time frame: 180 day period following index date
Use of Usual Care Therapy
Percentage of patients attending two or more system-provided therapy sessions
Time frame: 180 day period following index date
Use of Bridging Therapy
Percentage of patients attending two or more study-provided bridging therapy sessions
Time frame: 180 day period following index date
Use of Usual Care Therapy Following Bridging Therapy
Of patients in study therapy, percentage who subsequently attend two or more system-provided therapy sessions
Time frame: 180 day period following index date
Baseline and Follow-up Safety Assessments - Safety Lab Tests
Percentage of patients with safety lab tests ordered and completed at baseline and 3 months
Time frame: index date to 180 days post-index date
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