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Safer Use of Antipsychotics in Youth

NCT03448575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 733

Last updated 2024-10-31

Study results available
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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.

Conditions

  • Child Behavior Disorders

Interventions

OTHER

Control - Provider Medication Alert Only

Simple text medication alert referencing Choosing Wisely guidelines.

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.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    collaborator OTHER

  • Seattle Children's Hospital

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Robert B Penfold, PhD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2020-06-30
Completion
2021-12-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03448575 on ClinicalTrials.gov