NCT03448575: SUAY

Safer Use of Antipsychotics in Youth

Completed NA Results posted Last updated 31 October 2024

What this trial tests

NA trial testing Control - Provider Medication Alert Only in Child Behavior Disorders in 733 participants. Completed in 24 December 2021.

Timeline

29 March 2018

Primary endpoint
30 June 2020

24 December 2021

Quick facts

Lead sponsor	Kaiser Permanente
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	733
Start date	29 March 2018
Primary completion	30 June 2020
Estimated completion	24 December 2021
Sites	4 locations across United States

Drugs / interventions tested

• Control - Provider Medication Alert Only
• Intervention - Alert + CAP Review AND Enhanced BH Access

Conditions studied

• Child Behavior Disorders — all drugs for Child Behavior Disorders →

Sponsor

Kaiser Permanente — full company profile →

Who can join

Adults 3 to 17, any sex, with Child Behavior Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Youths With Antipsychotic Orders at 6 Months Primary · 180 day period following index date

Measured by medication orders placed within the health system

Group	Value	95% CI
Control - Medication Alert Only	54.6
Intervention - Alert + CAP Review AND Enhanced BH Access	47.6

Days' Supply of Antipsychotics Ordered for Youth Primary · 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.

Group	Value	95% CI
Control - Medication Alert Only	128.2	± 57.9
Intervention - Alert + CAP Review AND Enhanced BH Access	118.5	± 61.6

Percent of Youths Using Antipsychotics at 6 Months Secondary · 180 day period following index date

Measured by medication fill data available to the health system

Group	Value	95% CI
Control - Medication Alert Only	39.1
Intervention - Alert + CAP Review AND Enhanced BH Access	35.5

Days' Supply of Antipsychotic Use by Youth Secondary · 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.

Group	Value	95% CI
Control - Medication Alert Only	95.2	± 62.0
Intervention - Alert + CAP Review AND Enhanced BH Access	87.7	± 60.5

Emergency Department/Urgent Care Visit Frequency Secondary · 180 day period following index date

Measured by utilization data; both for psychiatric crises and for all other reasons

Group	Value	95% CI
Control - Medication Alert Only	0.43	± 0.98
Intervention - Alert + CAP Review AND Enhanced BH Access	0.36	± 0.99

Baseline and Follow-up Safety Assessments - BMI Secondary · index date to 180 days post-index date

Percentage of patients with BMI measurements completed at baseline and 3 months

Group	Value	95% CI
Control - Medication Alert Only	65.5
Intervention - Alert + CAP Review AND Enhanced BH Access	54.9

Change to Psychotropic Medication Treatment Plan Secondary · 180 day period following index date

Percentage of patients with change to psychotropic medication treatment plan following exposure to study algorithm

Group	Value	95% CI
Control - Medication Alert Only	42.3
Intervention - Alert + CAP Review AND Enhanced BH Access	40.8

Behavioral Health (BH) Navigation Acceptance Secondary · 180 day period following index date

Percent of intervention arm patients that agree to BH navigation

Group	Value	95% CI
Intervention - Alert + CAP Review AND Enhanced BH Access	55.5

Use of Usual Care Therapy Secondary · 180 day period following index date

Percentage of patients attending two or more system-provided therapy sessions

Group	Value	95% CI
Control - Medication Alert Only	47.3
Intervention - Alert + CAP Review AND Enhanced BH Access	53.5

Use of Bridging Therapy Secondary · 180 day period following index date

Percentage of patients attending two or more study-provided bridging therapy sessions

Group	Value	95% CI
Intervention - Alert + CAP Review AND Enhanced BH Access	1.4

Use of Usual Care Therapy Following Bridging Therapy Secondary · 180 day period following index date

Of patients in study therapy, percentage who subsequently attend two or more system-provided therapy sessions

Group	Value	95% CI
Intervention - Alert + CAP Review AND Enhanced BH Access	1.437

Baseline and Follow-up Safety Assessments - Safety Lab Tests Secondary · index date to 180 days post-index date

Percentage of patients with safety lab tests ordered and completed at baseline and 3 months

Group	Value	95% CI
Control - Medication Alert Only	32.5
Intervention - Alert + CAP Review AND Enhanced BH Access	28.2

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Principles and procedures for data and safety monitoring in pragmatic clinical trials.
   Simon GE, Shortreed SM, Rossom RC, Penfold RB, et al · · 2019 · cited 24× · PMID 31815644 · DOI 10.1186/s13063-019-3869-3
2. Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol.
   Penfold RB, Thompson EE, Hilt RJ, Kelleher KJ, et al · · 2020 · cited 11× · PMID 33091587 · DOI 10.1016/j.cct.2020.106184
3. Trends Over Time in Antipsychotic Initiation at a Large Children's Health Care System.
   Chavez LJ, Kelleher KJ, Beck A, Clarke GN, et al · · 2021 · cited 8× · PMID 34143677 · DOI 10.1089/cap.2020.0190
4. 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.
   Penfold RB, Thompson EE, Hilt RJ, Schwartz N, et al · · 2022 · cited 5× · PMID 34256967 · DOI 10.1016/j.jaac.2021.04.010
5. Developing home-based telemental health services for youth: Practices from the SUAY Study.
   Schoenfelder Gonzalez E, Myers K, Thompson EE, King DA, et al · · 2021 · cited 4× · PMID 31342851 · DOI 10.1177/1357633x19863208
6. Safer and targeted use of antipsychotics in youth: an embedded, pragmatic randomized trial.
   Penfold RB, Idu AE, Coley RY, Cushing-Haugen KL, et al · · 2025 · cited 1× · PMID 39472075 · DOI 10.1111/jcpp.14059
7. Cost of Implementing an Evidence-Based Intervention to Support Safer Use of Antipsychotics in Youth.
   Chavez LJ, Richards JE, Fishman P, Yeung K, et al · · 2023 · PMID 37261566 · DOI 10.1007/s10488-023-01273-y