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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
| Seattle Children's Hospital | OTHER |
| University of Washington | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control - Provider Medication Alert Only | Other | Simple text medication alert referencing Choosing Wisely guidelines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Youths Using Antipsychotics at 6 Months | Measured by medication fill data available to the health system | 180 day period following index date |
| Days' Supply of Antipsychotic Use by Youth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert B Penfold, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Colorado Institute for Health Research | Aurora | Colorado | 80014 | United States | ||
| Nationwide Children's Hospital / Partners for Kids |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37261566 | Derived | 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. | |
| 34256967 | Derived |
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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.
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 to contact deliverables will be determined by NIH.
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We define "started" as the number of eligible participants for whom a study medication alert fired in Epic when the provider ordered an antipsychotic. A blinded study team member assessed for eligibility according to study criteria and marked as eligible or ineligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Control - Provider Medication Alert Only: Simple text medication alert referencing Choosing Wisely guidelines. |
| FG001 | 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 - 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Control - Provider Medication Alert Only: Simple text medication alert referencing Choosing Wisely guidelines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Youths With Antipsychotic Orders at 6 Months | Measured by medication orders placed within the health system | Posted | Number | percentage of youths | 180 day period following index date |
|
6 months per individual over a 2.5 year study period
No difference
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Control - Provider Medication Alert Only: Simple text medication alert referencing Choosing Wisely guidelines. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Penfold, PhD | Kaiser Permanente Washington Health Research Institute | 206-316-7544 | robert.b.penfold@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2019 | Dec 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 17, 2021 | Nov 23, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002653 | Child Behavior Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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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.
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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.
| 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. |
|
Average days' supply of antipsychotic medication (values fell between 1 and 180 days), as measured by medication fill data available to the health system for each participant. Only pharmacy claims captured by the health system were accounted for.
| 180 day period following index date |
| Emergency Department/Urgent Care Visit Frequency | Measured by utilization data; both for psychiatric crises and for all other reasons | 180 day period following index date |
| Baseline and Follow-up Safety Assessments - BMI | Percentage of patients with BMI measurements completed at baseline and 3 months | index date to 180 days post-index date |
| Change to Psychotropic Medication Treatment Plan | Percentage of patients with change to psychotropic medication treatment plan following exposure to study algorithm | 180 day period following index date |
| Behavioral Health (BH) Navigation Acceptance | Percent of intervention arm patients that agree to BH navigation | 180 day period following index date |
| Use of Usual Care Therapy | Percentage of patients attending two or more system-provided therapy sessions | 180 day period following index date |
| Use of Bridging Therapy | Percentage of patients attending two or more study-provided bridging therapy sessions | 180 day period following index date |
| Use of Usual Care Therapy Following Bridging Therapy | Of patients in study therapy, percentage who subsequently attend two or more system-provided therapy sessions | 180 day period following index date |
| Baseline and Follow-up Safety Assessments - Safety Lab Tests | Percentage of patients with safety lab tests ordered and completed at baseline and 3 months | index date to 180 days post-index date |
| Columbus |
| Ohio |
| 43205 |
| United States |
| Kaiser Permanente Center for Health Research - Northwest | Portland | Oregon | 97227 | United States |
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98115 | United States |
| 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. |
| 34143677 | 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. |
| 33091587 | 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. |
| 31342851 | 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. |
| BG001 | 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 - 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | days | 180 day period following index date |
|
|
|
| Secondary | Percent of Youths Using Antipsychotics at 6 Months | Measured by medication fill data available to the health system | Posted | Number | percent of youths | 180 day period following index date |
|
|
|
| Secondary | Days' Supply of Antipsychotic Use by Youth | Average days' supply of antipsychotic medication (values fell between 1 and 180 days), as measured by medication fill data available to the health system for each participant. Only pharmacy claims captured by the health system were accounted for. | Posted | Mean | Standard Deviation | days | 180 day period following index date |
|
|
|
| Secondary | Emergency Department/Urgent Care Visit Frequency | Measured by utilization data; both for psychiatric crises and for all other reasons | Posted | Mean | Standard Deviation | number of visits | 180 day period following index date |
|
|
|
| Secondary | Baseline and Follow-up Safety Assessments - BMI | Percentage of patients with BMI measurements completed at baseline and 3 months | Posted | Number | percent of patients | index date to 180 days post-index date |
|
|
|
| Secondary | Change to Psychotropic Medication Treatment Plan | Percentage of patients with change to psychotropic medication treatment plan following exposure to study algorithm | Posted | Number | percent of patients | 180 day period following index date |
|
|
|
| Secondary | Behavioral Health (BH) Navigation Acceptance | Percent of intervention arm patients that agree to BH navigation | Control arm patients were not offered behavioral health navigation. | Posted | Number | percent of patients | 180 day period following index date |
|
|
|
| Secondary | Use of Usual Care Therapy | Percentage of patients attending two or more system-provided therapy sessions | Posted | Number | percentage of patients | 180 day period following index date |
|
|
|
| Secondary | Use of Bridging Therapy | Percentage of patients attending two or more study-provided bridging therapy sessions | Control arm patients were not offered bridging therapy. | Posted | Number | percent of patients | 180 day period following index date |
|
|
|
| Secondary | Use of Usual Care Therapy Following Bridging Therapy | Of patients in study therapy, percentage who subsequently attend two or more system-provided therapy sessions | Formal statistical analyses were not conducted because only 5 intervention participants elected to participate in bridging therapy, which is too few participants to measure differences in subsequent use of usual care. Bridging therapy was not offered to control participants. | Posted | Number | percent of patients | 180 day period following index date |
|
|
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| Secondary | Baseline and Follow-up Safety Assessments - Safety Lab Tests | Percentage of patients with safety lab tests ordered and completed at baseline and 3 months | Posted | Number | percent | index date to 180 days post-index date |
|
|
|
| 0 |
| 385 |
| 0 |
| 385 |
| 0 |
| 385 |
| EG001 | 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 - 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. | 0 | 348 | 0 | 348 | 0 | 348 |
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