N/A N=733 Randomized Quadruple-blind Other

Safer Use of Antipsychotics in Youth

Child Behavior Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03448575 ↗

Enrolled (actual)

733

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Percent of Youths With Antipsychotic Orders at 6 Months — 54.6; 47.6 percentage of youths

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Control - Provider Medication Alert Only (Other); Intervention - Alert + CAP Review AND Enhanced BH Access (Other)
Age: Pediatric · 3+ yrs
Sex: All
Sponsor: Kaiser Permanente
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Youths With Antipsychotic Orders at 6 Months	54.6; 47.6	—
PRIMARY Days' Supply of Antipsychotics Ordered for Youth	128.2; 118.5	—
SECONDARY Percent of Youths Using Antipsychotics at 6 Months	39.1; 35.5	—
SECONDARY Days' Supply of Antipsychotic Use by Youth	95.2; 87.7	—
SECONDARY Emergency Department/Urgent Care Visit Frequency	0.43; 0.36	—
SECONDARY Baseline and Follow-up Safety Assessments - BMI	65.5; 54.9	—
SECONDARY Change to Psychotropic Medication Treatment Plan	42.3; 40.8	—
SECONDARY Behavioral Health (BH) Navigation Acceptance	55.5	—
SECONDARY Use of Usual Care Therapy	47.3; 53.5	—
SECONDARY Use of Bridging Therapy	1.4	—
SECONDARY Use of Usual Care Therapy Following Bridging Therapy	1.437	—
SECONDARY Baseline and Follow-up Safety Assessments - Safety Lab Tests	32.5; 28.2	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03448575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.