NCT03448575

Safer Use of Antipsychotics in Youth

A Targeted Approach To A Safer Use of Antipsychotics In Youth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 733 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Child Behavior Disorders

Interventions

Type	Name	Description
OTHER	Control - Provider Medication Alert Only	Simple text medication alert referencing Choosing Wisely guidelines.
OTHER	Intervention - Alert + CAP Review AND Enhanced BH Access	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.

Timeline

• Start date: 2018-03-29
• Primary completion: 2020-06-30
• Completion: 2021-12-24
• First posted: 2018-02-28
• Last updated: 2024-10-31
• Results posted: 2024-10-31

Locations

4 sites across 1 country: United States