Safer Use of Antipsychotics in Youth

Not Applicable

Completed

Conditions: Child Behavior Disorders

Interventions: Other: Control - Provider Medication Alert Only
Other: Intervention - Alert + CAP Review AND Enhanced BH Access

Registration Number: NCT03448575

Lead Sponsor: Kaiser Permanente

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 733

Inclusion Criteria

Patient is ≥ 3 and < 18 years of age at the time of the encounter at which the study alert fired (index date);
Patient is initiating a new episode of outpatient treatment with an antipsychotic medication. (New episodes are defined by no record of an antipsychotic medication being ordered within the health system as part of an outpatient care plan in the prior 180 days);
Study service (BH navigation, bridging therapy, CAP consult) ordered in Epic for the patient; (e.g., provider removed antipsychotic order and still ordered study services);

Exclusion Criteria

Patient has a diagnosed psychotic disorder, mania, autism spectrum disorder, or intellectual disability;
Patient was enrolled in the SUAY pilot study;
The antipsychotic entered is prochlorperazine (Comazol®);
An outpatient antipsychotic order is entered by a temporary provider in the health system (e.g., "doc of the day"). Orders placed by temporary providers do not count towards the 180 day medication free period for defining a new episode of care.
The antipsychotic order was placed within an urgent care, emergency department, or inpatient setting (to avoid intervening during a crisis). Orders placed in these settings do not count towards the 180 day medication free period for defining a new episode of care.
Primary language is not English

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control - Medication Alert Only	Control - Provider Medication Alert Only	The control arm medication alert is a simple text pop-up in the EMR that will inform the prescriber of Choosing Wisely® recommendations developed the American Psychiatric Association regarding antipsychotic medication use in children and adolescents.
Intervention - Alert + CAP Review AND Enhanced BH Access	Intervention - Alert + CAP Review AND Enhanced BH Access	The intervention alert prompts the prescriber to keep/remove the antipsychotic order, and/or order any study services: behavioral health navigation, expedited psychotherapy access, virtual consult with a child and adolescent psychiatrist (CAP). Passive case review by the study CAP will occur for all intervention arm cases. A virtual consult will be scheduled if the prescriber ordered it or the CAP needs to discuss the case. The CAP will provide the prescriber with a written summary of his/her review. Following review by the CAP, a navigator reaches out to the eligible intervention arm patient/family to offer extra support. The navigator's role is to (a) provide extra support to facilitate access and engagement in appropriate psychosocial therapies; (b) coordinate short-duration bridging therapy sessions for teens/families not engaged in psychotherapy, when appropriate; and (c) keep the prescriber informed of any clinically relevant updates.

Primary Outcome Measures

Name	Time	Method
Percent of Youths With Antipsychotic Orders at 6 Months	180 day period following index date	Measured by medication orders placed within the health system
Days' Supply of Antipsychotics Ordered for Youth	180 day period following index date	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.

Secondary Outcome Measures

Name	Time	Method
Change to Psychotropic Medication Treatment Plan	180 day period following index date	Percentage of patients with change to psychotropic medication treatment plan following exposure to study algorithm
Percent of Youths Using Antipsychotics at 6 Months	180 day period following index date	Measured by medication fill data available to the health system
Days' Supply of Antipsychotic Use by Youth	180 day period following index date	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.
Emergency Department/Urgent Care Visit Frequency	180 day period following index date	Measured by utilization data; both for psychiatric crises and for all other reasons
Baseline and Follow-up Safety Assessments - BMI	index date to 180 days post-index date	Percentage of patients with BMI measurements completed at baseline and 3 months
Behavioral Health (BH) Navigation Acceptance	180 day period following index date	Percent of intervention arm patients that agree to BH navigation
Use of Usual Care Therapy	180 day period following index date	Percentage of patients attending two or more system-provided therapy sessions
Use of Bridging Therapy	180 day period following index date	Percentage of patients attending two or more study-provided bridging therapy sessions
Use of Usual Care Therapy Following Bridging Therapy	180 day period following index date	Of patients in study therapy, percentage who subsequently attend two or more system-provided therapy sessions
Baseline and Follow-up Safety Assessments - Safety Lab Tests	index date to 180 days post-index date	Percentage of patients with safety lab tests ordered and completed at baseline and 3 months

Trial Locations

Locations (4): Kaiser Permanente Washington Health Research Institute
🇺🇸
Seattle, Washington, United States
Nationwide Children's Hospital / Partners for Kids
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Columbus, Ohio, United States
Kaiser Permanente Colorado Institute for Health Research
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Aurora, Colorado, United States
Kaiser Permanente Center for Health Research - Northwest
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Portland, Oregon, United States