Safer Use of Antipsychotics in Youth (SUAY)

A Targeted Approach To A Safer Use of Antipsychotics In Youth

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.

Study Overview

• Status: Completed
• Conditions: Child Behavior Disorders
• Intervention / Treatment: Other: Control - Provider Medication Alert Only; Other: Intervention - Alert + CAP Review AND Enhanced BH Access

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.

• Study Type: Interventional
• Enrollment (Actual): 733
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Kaiser Permanente Colorado Institute for Health Research
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital / Partners for Kids
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Center for Health Research - Northwest
  • Washington
    • Seattle, Washington, United States, 98115
      • Kaiser Permanente Washington Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control - 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.	Other: Control - Provider Medication Alert Only; Simple text medication alert referencing Choosing Wisely guidelines.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Youths With Antipsychotic Orders at 6 Months	Measured by medication orders placed within the health system	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.	180 day period following index date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Youths Using Antipsychotics at 6 Months	Measured by medication fill data available to the health system	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.	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 - BMI	Percentage of patients with BMI measurements 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
Baseline and Follow-up Safety Assessments - Safety Lab Tests	Percentage of patients with safety lab tests ordered and completed at baseline and 3 months	index date to 180 days post-index date

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: University of Washington; Seattle Children's Hospital; Nationwide Children's Hospital
• Investigators: Principal Investigator: Robert B Penfold, PhD, Kaiser Permanente

Publications and helpful links

General Publications

• Penfold RB, Thompson EE, Hilt RJ, Schwartz N, Robb AS, Correll CU, Newton D, Rogalski K, Earls MF, Kowatch RA, Beck A, Yarborough BJH, Crystal S, Vitiello B, Kelleher KJ, Simon GE. Development of a Symptom-Focused Model to Guide the Prescribing of Antipsychotics in Children and Adolescents: Results of the First Phase of the Safer Use of Antipsychotics in Youth (SUAY) Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):93-102. doi: 10.1016/j.jaac.2021.04.010. Epub 2021 May 4.
• Chavez LJ, Kelleher KJ, Beck A, Clarke GN, Penfold RB. Trends Over Time in Antipsychotic Initiation at a Large Children's Health Care System. J Child Adolesc Psychopharmacol. 2021 Jun;31(5):381-386. doi: 10.1089/cap.2020.0190.
• Penfold RB, Thompson EE, Hilt RJ, Kelleher KJ, Schwartz N, Beck A, Clarke GN, Ralston JD, Hartzler AL, Coley RY, Akosile M, Vitiello B, Simon GE. Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol. Contemp Clin Trials. 2020 Dec;99:106184. doi: 10.1016/j.cct.2020.106184. Epub 2020 Oct 20.
• Schoenfelder Gonzalez E, Myers K, Thompson EE, King DA, Glass AM, Penfold RB. Developing home-based telemental health services for youth: Practices from the SUAY Study. J Telemed Telecare. 2021 Feb;27(2):110-115. doi: 10.1177/1357633X19863208. Epub 2019 Jul 25.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 24, 2021

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Mental Health; Psychotropic; Youth; Quality Improvement; Medication Safety
• Additional Relevant MeSH Terms: Neurodevelopmental Disorders; Mental Disorders; Child Behavior Disorders
• Other Study ID Numbers: HHSN271201600002C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing plan is incorporated by reference into the contract governing the project. Any changes to the plan must be pre-approved by the NIH Contracting Officer. A de-identified database will be delivered to the NIH, along with a statistical report. Any datasets for public distribution (including to the National Database for Clinical Trials Related to Mental Illness) will be de-identified in compliance with HIPAA standard for de-identification.
• IPD Sharing Time Frame: A de-identified database will be delivered to the NIH on or before 12/24/2021, along with data dictionary and a study report.
• IPD Sharing Access Criteria: Access to contact deliverables will be determined by NIH.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No