Trial Outcomes & Findings for Safer Use of Antipsychotics in Youth (NCT NCT03448575)
NCT ID: NCT03448575
Last Updated: 2024-10-31
Results Overview
Measured by medication orders placed within the health system
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
733 participants
Primary outcome timeframe
180 day period following index date
Results posted on
2024-10-31
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
385
|
348
|
|
Overall Study
COMPLETED
|
385
|
348
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safer Use of Antipsychotics in Youth
Baseline characteristics by cohort
| Measure |
Control - Medication Alert Only
n=385 Participants
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
Total
n=733 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
385 Participants
n=99 Participants
|
348 Participants
n=107 Participants
|
733 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=99 Participants
|
183 Participants
n=107 Participants
|
366 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=99 Participants
|
165 Participants
n=107 Participants
|
367 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
324 Participants
n=99 Participants
|
283 Participants
n=107 Participants
|
607 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
282 Participants
n=99 Participants
|
265 Participants
n=107 Participants
|
547 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
33 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
385 participants
n=99 Participants
|
348 participants
n=107 Participants
|
733 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 180 day period following index dateMeasured by medication orders placed within the health system
Outcome measures
| Measure |
Control - Medication Alert Only
n=385 Participants
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Percent of Youths With Antipsychotic Orders at 6 Months
|
54.6 percentage of youths
|
47.6 percentage of youths
|
PRIMARY outcome
Timeframe: 180 day period following index dateAverage 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.
Outcome measures
| Measure |
Control - Medication Alert Only
n=385 Participants
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Days' Supply of Antipsychotics Ordered for Youth
|
128.2 days
Standard Deviation 57.9
|
118.5 days
Standard Deviation 61.6
|
SECONDARY outcome
Timeframe: 180 day period following index dateMeasured by medication fill data available to the health system
Outcome measures
| Measure |
Control - Medication Alert Only
n=385 Participants
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Percent of Youths Using Antipsychotics at 6 Months
|
39.1 percent of youths
|
35.5 percent of youths
|
SECONDARY outcome
Timeframe: 180 day period following index dateAverage 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.
Outcome measures
| Measure |
Control - Medication Alert Only
n=385 Participants
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Days' Supply of Antipsychotic Use by Youth
|
95.2 days
Standard Deviation 62.0
|
87.7 days
Standard Deviation 60.5
|
SECONDARY outcome
Timeframe: 180 day period following index dateMeasured by utilization data; both for psychiatric crises and for all other reasons
Outcome measures
| Measure |
Control - Medication Alert Only
n=385 Participants
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Emergency Department/Urgent Care Visit Frequency
|
0.43 number of visits
Standard Deviation 0.98
|
0.36 number of visits
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: index date to 180 days post-index datePercentage of patients with BMI measurements completed at baseline and 3 months
Outcome measures
| Measure |
Control - Medication Alert Only
n=385 Participants
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Baseline and Follow-up Safety Assessments - BMI
|
65.5 percent of patients
|
54.9 percent of patients
|
SECONDARY outcome
Timeframe: 180 day period following index datePercentage of patients with change to psychotropic medication treatment plan following exposure to study algorithm
Outcome measures
| Measure |
Control - Medication Alert Only
n=385 Participants
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Change to Psychotropic Medication Treatment Plan
|
42.3 percent of patients
|
40.8 percent of patients
|
SECONDARY outcome
Timeframe: 180 day period following index datePopulation: Control arm patients were not offered behavioral health navigation.
Percent of intervention arm patients that agree to BH navigation
Outcome measures
| Measure |
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Behavioral Health (BH) Navigation Acceptance
|
—
|
55.5 percent of patients
|
SECONDARY outcome
Timeframe: 180 day period following index datePercentage of patients attending two or more system-provided therapy sessions
Outcome measures
| Measure |
Control - Medication Alert Only
n=385 Participants
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Use of Usual Care Therapy
|
47.3 percentage of patients
|
53.5 percentage of patients
|
SECONDARY outcome
Timeframe: 180 day period following index datePopulation: Control arm patients were not offered bridging therapy.
Percentage of patients attending two or more study-provided bridging therapy sessions
Outcome measures
| Measure |
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Use of Bridging Therapy
|
—
|
1.4 percent of patients
|
SECONDARY outcome
Timeframe: 180 day period following index datePopulation: 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.
Of patients in study therapy, percentage who subsequently attend two or more system-provided therapy sessions
Outcome measures
| Measure |
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Use of Usual Care Therapy Following Bridging Therapy
|
—
|
1.437 percent of patients
|
SECONDARY outcome
Timeframe: index date to 180 days post-index datePercentage of patients with safety lab tests ordered and completed at baseline and 3 months
Outcome measures
| Measure |
Control - Medication Alert Only
n=385 Participants
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.
|
Intervention - Alert + CAP Review AND Enhanced BH Access
n=348 Participants
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.
|
|---|---|---|
|
Baseline and Follow-up Safety Assessments - Safety Lab Tests
|
32.5 percent
|
28.2 percent
|
Adverse Events
Control - Medication Alert Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention - Alert + CAP Review AND Enhanced BH Access
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert Penfold, PhD
Kaiser Permanente Washington Health Research Institute
Phone: 206-316-7544
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place