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Completed

NCT Number: NCT03448575

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.

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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Colorado Institute for Health Research, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control - Provider Medication Alert Only

Other

Simple text medication alert referencing Choosing Wisely guidelines.

Intervention - Alert + CAP Review AND Enhanced BH Access

Other

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.

Primary outcomes

  1. Percent of Youths With Antipsychotic Orders at 6 Months

    Time frame: 180 day period following index date

    Measured by medication orders placed within the health system

  2. Days' Supply of Antipsychotics Ordered for Youth

    Time frame: 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.

Secondary outcomes

  1. Percent of Youths Using Antipsychotics at 6 Months

    Time frame: 180 day period following index date

    Measured by medication fill data available to the health system

  2. Days' Supply of Antipsychotic Use by Youth

    Time frame: 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.

  3. Emergency Department/Urgent Care Visit Frequency

    Time frame: 180 day period following index date

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

  4. Baseline and Follow-up Safety Assessments - BMI

    Time frame: index date to 180 days post-index date

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

  5. Change to Psychotropic Medication Treatment Plan

    Time frame: 180 day period following index date

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

  6. Behavioral Health (BH) Navigation Acceptance

    Time frame: 180 day period following index date

    Percent of intervention arm patients that agree to BH navigation

  7. Use of Usual Care Therapy

    Time frame: 180 day period following index date

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

  8. Use of Bridging Therapy

    Time frame: 180 day period following index date

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

  9. Use of Usual Care Therapy Following Bridging Therapy

    Time frame: 180 day period following index date

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

  10. Baseline and Follow-up Safety Assessments - Safety Lab Tests

    Time frame: index date to 180 days post-index date

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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Nationwide Children's Hospital
  • Seattle Children's Hospital
  • University of Washington

Registry information

Official study title

A Targeted Approach To A Safer Use of Antipsychotics In Youth

Acronym: SUAY

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 28, 2018
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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