Safer Use of Antipsychotics in Youth

Child Behavior Disorders Clinical Trial

— SUAY  

Official title:

A Targeted Approach To A Safer Use of Antipsychotics In Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448575
• Other study ID #: HHSN271201600002C
• Status: Completed
• Phase: N/A
• Start date: March 29, 2018
• Est. completion date: December 24, 2021

Study information

• Verified date: April 2022
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 747
• Est. completion date: December 24, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior Disorders
• Mental Disorders

Intervention

Other:
• Control - Provider Medication Alert Only
Simple text medication alert referencing Choosing Wisely guidelines.
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	Nationwide Children's Hospital, Seattle Children's Hospital, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of youth with antipsychotic orders at 6 months	Measured by medication orders placed within the health system	180 day period following index date
Primary	Total person-months of antipsychotics ordered for youth	Measured by medication orders placed within the health system	180 day period following index date
Secondary	Percent of youth using antipsychotics at 6 months	Measured by medication fill data available to the health system	180 day period following index date
Secondary	Total person-months of antipsychotic use by youth	Measured by medication fill data available to the health system	180 day period following index date
Secondary	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
Secondary	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
Secondary	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
Secondary	Behavioral health (BH) navigation acceptance	Percent of intervention arm patients that agree to BH navigation	180 day period following index date
Secondary	Use of usual care therapy	Percentage of patients attending two or more system-provided therapy sessions	180 day period following index date
Secondary	Use of bridging therapy	Percentage of patients attending two or more study-provided bridging therapy sessions	180 day period following index date
Secondary	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