Safer Use of Antipsychotics in Youth

Study Overview
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Brief Summary
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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
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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: Antipsychotics are not recommended 1st line treatment for non-psychotic disorders; A child and adolescent psychiatrist (CAP) will review antipsychotic usage by youth; 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.

Official Title
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A Targeted Approach To A Safer Use of Antipsychotics In Youth

Conditions
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Child Behavior Disorders

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Providers are preassigned to one of two study arms: usual care control or intervention arm. Patients are assigned to the same arm as the provider triggering the best practice alert and study algorithm.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control - Medication Alert Only<br>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. | Other: Control - Provider Medication Alert Only<br>* Simple text medication alert referencing Choosing Wisely guidelines.<br>|
| Experimental: Intervention - Alert + CAP Review AND Enhanced BH Access<br>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. | Other: Intervention - Alert + CAP Review AND Enhanced BH Access<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of youth with antipsychotic orders at 6 months | Measured by medication orders placed within the health system | 180 day period following index date | 
| Total person-months of antipsychotics ordered for youth | Measured by medication orders placed within the health system | 180 day period following index date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of youth using antipsychotics at 6 months | Measured by medication fill data available to the health system | 180 day period following index date | 
| Total person-months of antipsychotic use by youth | Measured by medication fill data available to the health system | 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 | 180 day period following index date | 
| Baseline and follow-up safety assessments | Percentage of patients with BMI measurements, and with safety lab tests ordered and completed at baseline and 3 months | 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 | 180 day period following index date | 
| Behavioral health (BH) navigation acceptance | Percent of intervention arm patients that agree to BH navigation | 180 day period following index date | 
| Use of usual care therapy | Percentage of patients attending two or more system-provided therapy sessions | 180 day period following index date | 
| Use of bridging therapy | Percentage of patients attending two or more study-provided bridging therapy sessions | 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 | 180 day period following index date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Youth, Mental Health, Psychotropic, Medication Safety, Quality Improvement