Trial Outcomes & Findings for Suicide Prediction and Prevention for People at Risk for Opioid Use Disorder: Supplement to COMPUTE 2.0 (NCT NCT04939727)
NCT ID: NCT04939727
Last Updated: 2023-08-31
Results Overview
EHR documentation of a completed Columbia Suicide Severity Rating Scale (CSSRS) on the same day or in the 14 days following any outpatient visit during the observation period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
Observation period (up to 12 months)
Results posted on
2023-08-31
Participant Flow
Study patients had index visits at randomized clinics between August 3, 2021 and April 30, 2022. The index visit was the first visit during the accrual period at which the patient met all study eligibility criteria. First participant enrolled on August 3rd, 2021.
Unit of analysis: Primary Care Clinics
Participant milestones
| Measure |
OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm)
Providers that practice in the clinics in this intervention arm will receive access to the OUD-CDS + Suicide Risk Model associated CDS, for all eligible encounters.
OUD-CDS + Suicide Risk Model associated CDS: Access to OUD-CDS + Suicide Risk CDS
|
Control
Providers that practice in the clinics in this control arm will not receive any access to the OUD-CDS + Suicide Risk Model associated CDS, however these clinical decision-support tools will run "silently" in the background, collecting data on eligible encounters.
|
|---|---|---|
|
Overall Study
STARTED
|
69 8
|
46 7
|
|
Overall Study
COMPLETED
|
69 8
|
46 7
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Suicide Prediction and Prevention for People at Risk for Opioid Use Disorder: Supplement to COMPUTE 2.0
Baseline characteristics by cohort
| Measure |
OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm)
n=69 Participants
Providers that practice in the clinics in this intervention arm will receive access to the OUD-CDS + Suicide Risk Model associated CDS, for all eligible encounters.
OUD-CDS + Suicide Risk Model associated CDS: Access to OUD-CDS + Suicide Risk CDS
|
Control
n=46 Participants
Providers that practice in the clinics in this control arm will not receive any access to the OUD-CDS + Suicide Risk Model associated CDS, however these clinical decision-support tools will run "silently" in the background, collecting data on eligible encounters.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
37.6 years
STANDARD_DEVIATION 12.0 • n=107 Participants
|
39.3 years
STANDARD_DEVIATION 12.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=99 Participants
|
46 participants
n=107 Participants
|
115 participants
n=206 Participants
|
|
Medicaid
|
57 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Observation period (up to 12 months)EHR documentation of a completed Columbia Suicide Severity Rating Scale (CSSRS) on the same day or in the 14 days following any outpatient visit during the observation period.
Outcome measures
| Measure |
OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm)
n=69 Participants
Providers that practice in the clinics in this intervention arm will receive access to the OUD-CDS + Suicide Risk Model associated CDS, for all eligible encounters.
OUD-CDS + Suicide Risk Model associated CDS: Access to OUD-CDS + Suicide Risk CDS
|
Control
n=46 Participants
Providers that practice in the clinics in this control arm will not receive any access to the OUD-CDS + Suicide Risk Model associated CDS, however these clinical decision-support tools will run "silently" in the background, collecting data on eligible encounters.
|
|---|---|---|
|
Number of Participants With CSSRS Completion on the Same Day or in the 14 Days Following Any Outpatient Visit
|
14 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Observation period (up to 12 months)Population: All outpatient visits between enrollment and the end of the observation period were assessed for appropriate outpatient mental health care engagement. Multiple visits per patient were possible during this time period.
Adequacy of engagement with mental health care following outpatient visits that occurred between the index visit and the end of the study period. Engagement was adequate if acute suicide risk was 1) documented as moderate or high and the patient had a follow-up mental health visit within 30 days, or 2) undocumented but the patient had a follow-up mental health visit within 30 days, or 3) documented as low.
Outcome measures
| Measure |
OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm)
n=911 Outpatient visits
Providers that practice in the clinics in this intervention arm will receive access to the OUD-CDS + Suicide Risk Model associated CDS, for all eligible encounters.
OUD-CDS + Suicide Risk Model associated CDS: Access to OUD-CDS + Suicide Risk CDS
|
Control
n=554 Outpatient visits
Providers that practice in the clinics in this control arm will not receive any access to the OUD-CDS + Suicide Risk Model associated CDS, however these clinical decision-support tools will run "silently" in the background, collecting data on eligible encounters.
|
|---|---|---|
|
Number of Outpatient Visits With Adequate Mental Health Engagement
|
789 Outpatient visits
|
489 Outpatient visits
|
PRIMARY outcome
Timeframe: Two time periods: 1) 12 months prior to enrollment (index visit), and 2) between enrollment and end of observation period (up to 12 months)Identification of fatal or non-fatal suicide attempts, using ICD-10 diagnostic codes assigned at inpatient or outpatient visits during the outcome measure time frame
Outcome measures
| Measure |
OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm)
n=69 Participants
Providers that practice in the clinics in this intervention arm will receive access to the OUD-CDS + Suicide Risk Model associated CDS, for all eligible encounters.
OUD-CDS + Suicide Risk Model associated CDS: Access to OUD-CDS + Suicide Risk CDS
|
Control
n=46 Participants
Providers that practice in the clinics in this control arm will not receive any access to the OUD-CDS + Suicide Risk Model associated CDS, however these clinical decision-support tools will run "silently" in the background, collecting data on eligible encounters.
|
|---|---|---|
|
Number of Participants With One or More Suicide Attempts
12 months prior to enrollment
|
19 Participants
|
15 Participants
|
|
Number of Participants With One or More Suicide Attempts
Between enrollment and observation period
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Two time periods: 1) 12 months prior to enrollment (index date), and 2) between enrollment and end of observation period (up to 12 months)Identification of opioid overdoses, using ICD-10 diagnostic codes assigned at inpatient or outpatient visits during the outcome measure time frame
Outcome measures
| Measure |
OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm)
n=69 Participants
Providers that practice in the clinics in this intervention arm will receive access to the OUD-CDS + Suicide Risk Model associated CDS, for all eligible encounters.
OUD-CDS + Suicide Risk Model associated CDS: Access to OUD-CDS + Suicide Risk CDS
|
Control
n=46 Participants
Providers that practice in the clinics in this control arm will not receive any access to the OUD-CDS + Suicide Risk Model associated CDS, however these clinical decision-support tools will run "silently" in the background, collecting data on eligible encounters.
|
|---|---|---|
|
Number of Participants With One or More Opioid Overdoses
12 months prior to enrollment
|
8 Participants
|
7 Participants
|
|
Number of Participants With One or More Opioid Overdoses
Between enrollment and end of observation period
|
2 Participants
|
5 Participants
|
Adverse Events
OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm)
Serious events: 46 serious events
Other events: 6 other events
Deaths: 3 deaths
Control
Serious events: 23 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm)
n=69 participants at risk
Providers that practice in the clinics in this intervention arm will receive access to the OUD-CDS + Suicide Risk Model associated CDS, for all eligible encounters.
OUD-CDS + Suicide Risk Model associated CDS: Access to OUD-CDS + Suicide Risk CDS
|
Control
n=46 participants at risk
Providers that practice in the clinics in this control arm will not receive any access to the OUD-CDS + Suicide Risk Model associated CDS, however these clinical decision-support tools will run "silently" in the background, collecting data on eligible encounters.
|
|---|---|---|
|
General disorders
Emergency Department Encounter
|
60.9%
42/69 • Between enrollment (index date) and end of observation period (up to 12 months).
|
47.8%
22/46 • Between enrollment (index date) and end of observation period (up to 12 months).
|
|
General disorders
Inpatient stay
|
20.3%
14/69 • Between enrollment (index date) and end of observation period (up to 12 months).
|
10.9%
5/46 • Between enrollment (index date) and end of observation period (up to 12 months).
|
Other adverse events
| Measure |
OUD-CDS + Suicide Risk Model Associated CDS (Intervention Arm)
n=69 participants at risk
Providers that practice in the clinics in this intervention arm will receive access to the OUD-CDS + Suicide Risk Model associated CDS, for all eligible encounters.
OUD-CDS + Suicide Risk Model associated CDS: Access to OUD-CDS + Suicide Risk CDS
|
Control
n=46 participants at risk
Providers that practice in the clinics in this control arm will not receive any access to the OUD-CDS + Suicide Risk Model associated CDS, however these clinical decision-support tools will run "silently" in the background, collecting data on eligible encounters.
|
|---|---|---|
|
General disorders
Overdose
|
8.7%
6/69 • Between enrollment (index date) and end of observation period (up to 12 months).
|
6.5%
3/46 • Between enrollment (index date) and end of observation period (up to 12 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place