Safer Use of Antipsychotics in Youth

NCT03448575 | Completed Results DMC

• 1 other identifier: HHSN271201600002C
• Study Type: interventional
• Target: 733
• Locations: 1 country
• Sites: 4

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.

Conditions

Child Behavior Disorders

Keywords

Youth; Mental Health; Psychotropic; Medication Safety; Quality Improvement

Outcome Measures

Primary Outcomes (2)

• Percent of Youths With Antipsychotic Orders at 6 Months

  Measured by medication orders placed within the health system

  180 day period following index date

• Days' Supply of Antipsychotics Ordered for Youth

  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.

  180 day period following index date

Secondary Outcomes (10)

• Percent of Youths Using Antipsychotics at 6 Months

  180 day period following index date

• Days' Supply of Antipsychotic Use by Youth

  180 day period following index date

• Emergency Department/Urgent Care Visit Frequency

  180 day period following index date

• Baseline and Follow-up Safety Assessments - BMI

  index date to 180 days post-index date

• Change to Psychotropic Medication Treatment Plan

  180 day period following index date

Study Arms (2)

Control - Medication Alert Only

SHAM COMPARATOR

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

Intervention - Alert + CAP Review AND Enhanced BH Access

EXPERIMENTAL

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

Interventions

Control - Provider Medication Alert Only OTHER

Simple text medication alert referencing Choosing Wisely guidelines.

Control - Medication Alert Only

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.

Intervention - Alert + CAP Review AND Enhanced BH Access

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Nationwide Children's Hospital: collaborator
• Seattle Children's Hospital: collaborator
• University of Washington: collaborator

Study Sites (4)

Kaiser Permanente Colorado Institute for Health Research

Aurora, Colorado, 80014, United States

Location

Nationwide Children's Hospital / Partners for Kids

Columbus, Ohio, 43205, United States

Location

Kaiser Permanente Center for Health Research - Northwest

Portland, Oregon, 97227, United States

Location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98115, United States

Location

Related Publications (5)

• Chavez LJ, Richards JE, Fishman P, Yeung K, Renz A, Quintana LM, Massimino S, Penfold RB. Cost of Implementing an Evidence-Based Intervention to Support Safer Use of Antipsychotics in Youth. Adm Policy Ment Health. 2023 Sep;50(5):725-733. doi: 10.1007/s10488-023-01273-y. Epub 2023 Jun 1.

  PMID: 37261566 DERIVED

• Penfold RB, Thompson EE, Hilt RJ, Schwartz N, Robb AS, Correll CU, Newton D, Rogalski K, Earls MF, Kowatch RA, Beck A, Yarborough BJH, Crystal S, Vitiello B, Kelleher KJ, Simon GE. Development of a Symptom-Focused Model to Guide the Prescribing of Antipsychotics in Children and Adolescents: Results of the First Phase of the Safer Use of Antipsychotics in Youth (SUAY) Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):93-102. doi: 10.1016/j.jaac.2021.04.010. Epub 2021 May 4.

  PMID: 34256967 DERIVED

• Chavez LJ, Kelleher KJ, Beck A, Clarke GN, Penfold RB. Trends Over Time in Antipsychotic Initiation at a Large Children's Health Care System. J Child Adolesc Psychopharmacol. 2021 Jun;31(5):381-386. doi: 10.1089/cap.2020.0190.

  PMID: 34143677 DERIVED

• Penfold RB, Thompson EE, Hilt RJ, Kelleher KJ, Schwartz N, Beck A, Clarke GN, Ralston JD, Hartzler AL, Coley RY, Akosile M, Vitiello B, Simon GE. Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol. Contemp Clin Trials. 2020 Dec;99:106184. doi: 10.1016/j.cct.2020.106184. Epub 2020 Oct 20.

  PMID: 33091587 DERIVED

• 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. 2021 Feb;27(2):110-115. doi: 10.1177/1357633X19863208. Epub 2019 Jul 25.

  PMID: 31342851 DERIVED

MeSH Terms

Conditions

Child Behavior Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Personal Satisfaction; Behavior

Limitations and Caveats

While inclusion/exclusion criteria were manually confirmed by chart review, \~7% of patients enrolled with an exclusion diagnosis. We obtained this information via administrative claims data at study end. External claims data were unavailable in real time when the BPA fired. EHR functionality cannot differentiate a de novo prescription order from a "historical medication". Some new patients had initial prescriptions written elsewhere; the BPA fired when study clinicians continued treatment.

Results Point of Contact

• Title: Robert Penfold, PhD
• Organization: Kaiser Permanente Washington Health Research Institute

robert.b.penfold@kp.org

206-316-7544

Study Officials

• Robert B Penfold, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 28, 2018
• Study Start: March 29, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 24, 2021
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: A de-identified database will be delivered to the NIH on or before 12/24/2021, along with data dictionary and a study report.
• Access Criteria: Access to contact deliverables will be determined by NIH.

Locations

US (4)