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
|Condition or disease||Intervention/treatment||Phase|
|Child Behavior Disorders||Other: Control - Provider Medication Alert Only Other: Intervention - Alert + CAP Review AND Enhanced BH Access||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||747 participants|
|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.|
|Official Title:||A Targeted Approach To A Safer Use of Antipsychotics In Youth|
|Actual Study Start Date :||March 29, 2018|
|Actual Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 24, 2021|
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
Simple text medication alert referencing Choosing Wisely guidelines.
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
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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448575
|United States, Colorado|
|Kaiser Permanente Colorado Institute for Health Research|
|Aurora, Colorado, United States, 80014|
|United States, Ohio|
|Nationwide Children's Hospital / Partners for Kids|
|Columbus, Ohio, United States, 43205|
|United States, Oregon|
|Kaiser Permanente Center for Health Research - Northwest|
|Portland, Oregon, United States, 97227|
|United States, Washington|
|Kaiser Permanente Washington Health Research Institute|
|Seattle, Washington, United States, 98115|
|Principal Investigator:||Robert B Penfold, PhD||Kaiser Permanente|