Clinical trial NCT03448575: Safer Use of Antipsychotics in Youth
Official title: A Targeted Approach To A Safer Use of Antipsychotics In Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Disorders
Keywords: Youth
Mental Health
Psychotropic
Medication Safety
Quality Improvement
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
name: Seattle Children's Hospital
name: University of Washington
First posted: 2018-02-28
Enrollment: 733
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Providers are preassigned to one of two study arms: usual care control or intervention arm. Patients are assigned to the same arm as the provider triggering the best practice alert and study algorithm.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Youths With Antipsychotic Orders at 6 Months
timeFrame: 180 day period following index date
measure: Days' Supply of Antipsychotics Ordered for Youth
timeFrame: 180 day period following index date
Secondary outcomes:
measure: Percent of Youths Using Antipsychotics at 6 Months
timeFrame: 180 day period following index date
measure: Days' Supply of Antipsychotic Use by Youth
timeFrame: 180 day period following index date
measure: Emergency Department/Urgent Care Visit Frequency
timeFrame: 180 day period following index date
measure: Baseline and Follow-up Safety Assessments - BMI
timeFrame: index date to 180 days post-index date
measure: Change to Psychotropic Medication Treatment Plan
timeFrame: 180 day period following index date
measure: Behavioral Health (BH) Navigation Acceptance
timeFrame: 180 day period following index date
measure: Use of Usual Care Therapy
timeFrame: 180 day period following index date
measure: Use of Bridging Therapy
timeFrame: 180 day period following index date
measure: Use of Usual Care Therapy Following Bridging Therapy
timeFrame: 180 day period following index date
measure: Baseline and Follow-up Safety Assessments - Safety Lab Tests
timeFrame: index date to 180 days post-index date
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Kaiser Permanente Colorado Institute for Health Research
state: Colorado
city: Columbus
country: United States
facility: Nationwide Children's Hospital / Partners for Kids
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research - Northwest
state: Oregon
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Robert B Penfold, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.