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Safer Use of Antipsychotics in Youth (SUAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03448575
Recruitment Status : Active, not recruiting
First Posted : February 28, 2018
Last Update Posted : July 23, 2020
Sponsor:
Collaborators:
Nationwide Children's Hospital
Seattle Children's Hospital
University of Washington
Information provided by (Responsible Party):
Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE February 21, 2018
First Posted Date  ICMJE February 28, 2018
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE March 29, 2018
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • Percent of youth with antipsychotic orders at 6 months [ Time Frame: 180 day period following index date ]
    Measured by medication orders placed within the health system
  • Total person-months of antipsychotics ordered for youth [ Time Frame: 180 day period following index date ]
    Measured by medication orders placed within the health system
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • Percent of youth using antipsychotics at 6 months [ Time Frame: 180 day period following index date ]
    Measured by medication fill data available to the health system
  • Total person-months of antipsychotic use by youth [ Time Frame: 180 day period following index date ]
    Measured by medication fill data available to the health system
  • 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
  • Baseline and follow-up safety assessments [ Time Frame: index date to 180 days post-index date ]
    Percentage of patients with BMI measurements, and with safety lab tests ordered and completed at baseline and 3 months
  • 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
  • Behavioral health (BH) navigation acceptance [ Time Frame: 180 day period following index date ]
    Percent of intervention arm patients that agree to BH navigation
  • Use of usual care therapy [ Time Frame: 180 day period following index date ]
    Percentage of patients attending two or more system-provided therapy sessions
  • Use of bridging therapy [ Time Frame: 180 day period following index date ]
    Percentage of patients attending two or more study-provided bridging therapy sessions
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safer Use of Antipsychotics in Youth
Official Title  ICMJE A Targeted Approach To A Safer Use of Antipsychotics In Youth
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Waivers of consent have been obtained for providers and for patients/parents/guardians. None are informed of the study design or study activities by arm. The investigator is blind to study arm assignment of providers and patients. Only automated data collection is utilized for this practical trial. Study arm is masked for the programmer/analyst pulling outcomes data from health system records. Study arm will also be masked for study staff verifying study eligibility prior to the official study enrollment. Arm is not masked for study intervention staff (consulting psychiatrists, behavioral health navigators, bridging therapists) since these staff only interact with intervention arm subjects.
Primary Purpose: Other
Condition  ICMJE Child Behavior Disorders
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: 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.

    Intervention: Other: Intervention - Alert + CAP Review AND Enhanced BH Access
Publications * 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. 2019 Jul 25:1357633X19863208. doi: 10.1177/1357633X19863208. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 22, 2020)
747
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2018)
800
Estimated Study Completion Date  ICMJE December 24, 2021
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03448575
Other Study ID Numbers  ICMJE HHSN271201600002C
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Time Frame: A de-identified database will be delivered to the NIH on or before 6/24/2021, along with data dictionary and a study report.
Access Criteria: Access to contact deliverables will be determined by NIH.
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE
  • Nationwide Children's Hospital
  • Seattle Children's Hospital
  • University of Washington
Investigators  ICMJE
Principal Investigator: Robert B Penfold, PhD Kaiser Permanente
PRS Account Kaiser Permanente
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP