CompletedNCT03448575SUAYUpdated Oct 31, 2024Results posted

Safer Use of Antipsychotics in Youth

An interventional study of Control - Provider Medication Alert Only and Intervention - Alert + CAP Review AND Enhanced BH Access in Child Behavior Disorders, sponsored by Kaiser Permanente. Completed at 4 sites in United States. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by Kaiser Permanente · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 733
Allocation: Randomized
Ages: 3 Years to 17 Years
Sex: All

Study 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.

Read the 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:

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.

Conditions studied

Child Behavior Disorders

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Keywords

Youth
Mental Health
Psychotropic
Medication Safety
Quality Improvement

Who can participate

Ages eligible: 3 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 733 participants (actual)

Study arms

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
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

Interventions

OtherControl - Provider Medication Alert Only
Simple text medication alert referencing Choosing Wisely guidelines.
OtherIntervention - 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 researchers measure

Primary outcomes

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

Secondary outcomes

Percent of Youths Using Antipsychotics at 6 Months
Measured by medication fill data available to the health system
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 180 day period following index date
Behavioral Health (BH) Navigation Acceptance
Percent of intervention arm patients that agree to BH navigation
Time frame: 180 day period following index date
Use of Usual Care Therapy
Percentage of patients attending two or more system-provided therapy sessions
Time frame: 180 day period following index date
Use of Bridging Therapy
Percentage of patients attending two or more study-provided bridging therapy sessions
Time frame: 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
Time frame: 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
Time frame: index date to 180 days post-index date

Results

Posted Oct 31, 2024

Limitations and caveats

While inclusion/exclusion criteria were manually confirmed by chart review, \~7% of patients enrolled with an exclusion diagnosis. We obtained this information via administrative claims data at study end. External claims data were unavailable in real time when the BPA fired. EHR functionality cannot differentiate a de novo prescription order from a "historical medication". Some new patients had initial prescriptions written elsewhere; the BPA fired when study clinicians continued treatment.

Participant flow

Participant flow — Overall Study
Milestone	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Started	385	348
Completed	385	348
Not completed	0	0

Outcome measures

PrimaryPercent of Youths With Antipsychotic Orders at 6 Months

Measured by medication orders placed within the health system

Time frame:: 180 day period following index date
Reported as:: Number · percentage of youths

Percent of Youths With Antipsychotic Orders at 6 Months
percentage of youths	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Percent of Youths With Antipsychotic Orders at 6 Months	54.6	47.6

PrimaryDays' 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.

Time frame:: 180 day period following index date
Reported as:: Mean · days

Days' Supply of Antipsychotics Ordered for Youth
days	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Days' Supply of Antipsychotics Ordered for Youth	128.2 ± 57.9	118.5 ± 61.6

SecondaryPercent of Youths Using Antipsychotics at 6 Months

Measured by medication fill data available to the health system

Time frame:: 180 day period following index date
Reported as:: Number · percent of youths

Percent of Youths Using Antipsychotics at 6 Months
percent of youths	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Percent of Youths Using Antipsychotics at 6 Months	39.1	35.5

SecondaryDays' 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.

Time frame:: 180 day period following index date
Reported as:: Mean · days

Days' Supply of Antipsychotic Use by Youth
days	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Days' Supply of Antipsychotic Use by Youth	95.2 ± 62.0	87.7 ± 60.5

SecondaryEmergency Department/Urgent Care Visit Frequency

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

Time frame:: 180 day period following index date
Reported as:: Mean · number of visits

Emergency Department/Urgent Care Visit Frequency
number of visits	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Emergency Department/Urgent Care Visit Frequency	0.43 ± 0.98	0.36 ± 0.99

SecondaryBaseline and Follow-up Safety Assessments - BMI

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

Time frame:: index date to 180 days post-index date
Reported as:: Number · percent of patients

Baseline and Follow-up Safety Assessments - BMI
percent of patients	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Baseline and Follow-up Safety Assessments - BMI	65.5	54.9

SecondaryChange to Psychotropic Medication Treatment Plan

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

Time frame:: 180 day period following index date
Reported as:: Number · percent of patients

Change to Psychotropic Medication Treatment Plan
percent of patients	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Change to Psychotropic Medication Treatment Plan	42.3	40.8

SecondaryBehavioral Health (BH) Navigation Acceptance

Percent of intervention arm patients that agree to BH navigation

Time frame:: 180 day period following index date
Reported as:: Number · percent of patients

Behavioral Health (BH) Navigation Acceptance
percent of patients	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Behavioral Health (BH) Navigation Acceptance	—	55.5

SecondaryUse of Usual Care Therapy

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

Time frame:: 180 day period following index date
Reported as:: Number · percentage of patients

Use of Usual Care Therapy
percentage of patients	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Use of Usual Care Therapy	47.3	53.5

SecondaryUse of Bridging Therapy

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

Time frame:: 180 day period following index date
Reported as:: Number · percent of patients

Use of Bridging Therapy
percent of patients	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Use of Bridging Therapy	—	1.4

SecondaryUse of Usual Care Therapy Following Bridging Therapy

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

Time frame:: 180 day period following index date
Reported as:: Number · percent of patients

Use of Usual Care Therapy Following Bridging Therapy
percent of patients	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Use of Usual Care Therapy Following Bridging Therapy	—	1.437

SecondaryBaseline and Follow-up Safety Assessments - Safety Lab Tests

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

Time frame:: index date to 180 days post-index date
Reported as:: Number · percent

Baseline and Follow-up Safety Assessments - Safety Lab Tests
percent	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access
Baseline and Follow-up Safety Assessments - Safety Lab Tests	32.5	28.2

Adverse events

Collected over 6 months per individual over a 2.5 year study period. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Control - Medication Alert Only	0/385 (0%)	0/385 (0%)	0/385 (0%)
Intervention - Alert + CAP Review AND Enhanced BH Access	0/348 (0%)	0/348 (0%)	0/348 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access	Total
<=18 years	385	348	733
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access	Total
Female	183	183	366
Male	202	165	367

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access	Total
Hispanic or Latino	18	22	40
Not Hispanic or Latino	324	283	607
Unknown or Not Reported	43	43	86

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access	Total
American Indian or Alaska Native	1	2	3
Asian	3	4	7
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	35	29	64
White	282	265	547
More than one race	33	23	56
Unknown or Not Reported	30	25	55

Region of Enrollment
Region of Enrollment(participants)	Control - Medication Alert Only	Intervention - Alert + CAP Review AND Enhanced BH Access	Total
United States	385	348	733

Study locations

4 sites

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

References and documents

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. PubMed 34256967 ↗
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. PubMed 34143677 ↗
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. PubMed 33091587 ↗
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. PubMed 31342851 ↗

Study documents

Study protocol · Dec 20, 2019
Statistical analysis plan · Dec 17, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Analytic code

Registry details

Key details

Study ID: NCT03448575
Lead sponsor: Kaiser Permanente
Collaborators: Nationwide Children's Hospital, Seattle Children's Hospital, University of Washington
Responsible party: Sponsor
First posted: Feb 28, 2018
Start date: Mar 29, 2018
Primary completion: Jun 30, 2020
Completion: Dec 24, 2021
Results posted: Oct 31, 2024
Last update: Oct 31, 2024

Study contacts

Robert B Penfold, PhD

principal investigator · Kaiser Permanente

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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