Child Behavior Disorders
Conditions
Keywords
Youth, Mental Health, Psychotropic, Medication Safety, Quality Improvement
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.
Interventions
OTHERControl - Provider Medication Alert Only
Simple text medication alert referencing Choosing Wisely guidelines.
OTHERIntervention - 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.
Sponsors
Nationwide Children's Hospital
Seattle Children's Hospital
University of Washington
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Youths With Antipsychotic Orders at 6 Months | 180 day period following index date | Measured by medication orders placed within the health system |
| Days' Supply of Antipsychotics Ordered for Youth | 180 day period following index date | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department/Urgent Care Visit Frequency | 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 - BMI | index date to 180 days post-index date | Percentage of patients with BMI measurements completed at baseline and 3 months |
| Change to Psychotropic Medication Treatment Plan | 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 | 180 day period following index date | Percent of intervention arm patients that agree to BH navigation |
| Percent of Youths Using Antipsychotics at 6 Months | 180 day period following index date | Measured by medication fill data available to the health system |
| Use of Bridging Therapy | 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 | 180 day period following index date | Of patients in study therapy, percentage who subsequently attend two or more system-provided therapy sessions |
| Baseline and Follow-up Safety Assessments - Safety Lab Tests | index date to 180 days post-index date | Percentage of patients with safety lab tests ordered and completed at baseline and 3 months |
| Use of Usual Care Therapy | 180 day period following index date | Percentage of patients attending two or more system-provided therapy sessions |
| Days' Supply of Antipsychotic Use by Youth | 180 day period following index date | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 385 |
| 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. | 348 |
| Total | 733 |
Baseline characteristics
| Characteristic | Control - Medication Alert Only | Intervention - Alert + CAP Review AND Enhanced BH Access | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 385 Participants | 348 Participants | 733 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 22 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 324 Participants | 283 Participants | 607 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 43 Participants | 43 Participants | 86 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 29 Participants | 64 Participants |
| Race (NIH/OMB) More than one race | 33 Participants | 23 Participants | 56 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 30 Participants | 25 Participants | 55 Participants |
| Race (NIH/OMB) White | 282 Participants | 265 Participants | 547 Participants |
| Region of Enrollment United States | 385 participants | 348 participants | 733 participants |
| Sex: Female, Male Female | 183 Participants | 183 Participants | 366 Participants |
| Sex: Female, Male Male | 202 Participants | 165 Participants | 367 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 385 | 0 / 348 |
| other Total, other adverse events | 0 / 385 | 0 / 348 |
| serious Total, serious adverse events | 0 / 385 | 0 / 348 |
Outcome results
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.
Time frame: 180 day period following index date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Medication Alert Only | Days' Supply of Antipsychotics Ordered for Youth | 128.2 days | Standard Deviation 57.9 |
| Intervention - Alert + CAP Review AND Enhanced BH Access | Days' Supply of Antipsychotics Ordered for Youth | 118.5 days | Standard Deviation 61.6 |
Primary
Percent of Youths With Antipsychotic Orders at 6 Months
Measured by medication orders placed within the health system
Time frame: 180 day period following index date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control - Medication Alert Only | Percent of Youths With Antipsychotic Orders at 6 Months | 54.6 percentage of youths |
| Intervention - Alert + CAP Review AND Enhanced BH Access | Percent of Youths With Antipsychotic Orders at 6 Months | 47.6 percentage of youths |
Secondary
Baseline and Follow-up Safety Assessments - BMI
Percentage of patients with BMI measurements completed at baseline and 3 months
Time frame: index date to 180 days post-index date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control - Medication Alert Only | Baseline and Follow-up Safety Assessments - BMI | 65.5 percent of patients |
| Intervention - Alert + CAP Review AND Enhanced BH Access | Baseline and Follow-up Safety Assessments - BMI | 54.9 percent of patients |
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
Time frame: index date to 180 days post-index date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control - Medication Alert Only | Baseline and Follow-up Safety Assessments - Safety Lab Tests | 32.5 percent |
| Intervention - Alert + CAP Review AND Enhanced BH Access | Baseline and Follow-up Safety Assessments - Safety Lab Tests | 28.2 percent |
Secondary
Behavioral Health (BH) Navigation Acceptance
Percent of intervention arm patients that agree to BH navigation
Time frame: 180 day period following index date
Population: Control arm patients were not offered behavioral health navigation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention - Alert + CAP Review AND Enhanced BH Access | Behavioral Health (BH) Navigation Acceptance | 55.5 percent of patients |
Secondary
Change to Psychotropic Medication Treatment Plan
Percentage of patients with change to psychotropic medication treatment plan following exposure to study algorithm
Time frame: 180 day period following index date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control - Medication Alert Only | Change to Psychotropic Medication Treatment Plan | 42.3 percent of patients |
| Intervention - Alert + CAP Review AND Enhanced BH Access | Change to Psychotropic Medication Treatment Plan | 40.8 percent of patients |
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.
Time frame: 180 day period following index date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Medication Alert Only | Days' Supply of Antipsychotic Use by Youth | 95.2 days | Standard Deviation 62 |
| Intervention - Alert + CAP Review AND Enhanced BH Access | Days' Supply of Antipsychotic Use by Youth | 87.7 days | Standard Deviation 60.5 |
Secondary
Emergency Department/Urgent Care Visit Frequency
Measured by utilization data; both for psychiatric crises and for all other reasons
Time frame: 180 day period following index date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Medication Alert Only | Emergency Department/Urgent Care Visit Frequency | 0.43 number of visits | Standard Deviation 0.98 |
| Intervention - Alert + CAP Review AND Enhanced BH Access | Emergency Department/Urgent Care Visit Frequency | 0.36 number of visits | Standard Deviation 0.99 |
Secondary
Percent of Youths Using Antipsychotics at 6 Months
Measured by medication fill data available to the health system
Time frame: 180 day period following index date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control - Medication Alert Only | Percent of Youths Using Antipsychotics at 6 Months | 39.1 percent of youths |
| Intervention - Alert + CAP Review AND Enhanced BH Access | Percent of Youths Using Antipsychotics at 6 Months | 35.5 percent of youths |
Secondary
Use of Bridging Therapy
Percentage of patients attending two or more study-provided bridging therapy sessions
Time frame: 180 day period following index date
Population: Control arm patients were not offered bridging therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention - Alert + CAP Review AND Enhanced BH Access | Use of Bridging Therapy | 1.4 percent of patients |
Secondary
Use of Usual Care Therapy
Percentage of patients attending two or more system-provided therapy sessions
Time frame: 180 day period following index date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control - Medication Alert Only | Use of Usual Care Therapy | 47.3 percentage of patients |
| Intervention - Alert + CAP Review AND Enhanced BH Access | Use of Usual Care Therapy | 53.5 percentage of patients |
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
Time frame: 180 day period following index date
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention - Alert + CAP Review AND Enhanced BH Access | Use of Usual Care Therapy Following Bridging Therapy | 1.437 percent of patients |