Trial Outcomes & Findings for Clinical Decision Support for Opioid Use Disorders in Medical Settings (COMPUTE 2.0) (NCT NCT04198428)
NCT ID: NCT04198428
Last Updated: 2025-10-02
Results Overview
Patient has an ICD10 diagnosis code for OUD assigned at an encounter or added to the problem list
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10891 participants
Primary outcome timeframe
Index visit date through 30 days post-index, inclusive.
Results posted on
2025-10-02
Participant Flow
Unit of analysis: clinics
Participant milestones
| Measure |
Receives OUD-CDS
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
Overall Study
STARTED
|
5688 46
|
5509 46
|
|
Overall Study
COMPLETED
|
5538 46
|
5353 46
|
|
Overall Study
NOT COMPLETED
|
150 0
|
156 0
|
Reasons for withdrawal
| Measure |
Receives OUD-CDS
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
150
|
156
|
Baseline Characteristics
Clinical Decision Support for Opioid Use Disorders in Medical Settings (COMPUTE 2.0)
Baseline characteristics by cohort
| Measure |
Receives OUD-CDS
n=5538 Participants
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=5353 Participants
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
Total
n=10891 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
48 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Age, Customized
Age · 18-29
|
567 Participants
n=5 Participants
|
502 Participants
n=7 Participants
|
1069 Participants
n=5 Participants
|
|
Age, Customized
Age · 30-44
|
1877 Participants
n=5 Participants
|
1755 Participants
n=7 Participants
|
3632 Participants
n=5 Participants
|
|
Age, Customized
Age · 45-64
|
2387 Participants
n=5 Participants
|
2338 Participants
n=7 Participants
|
4725 Participants
n=5 Participants
|
|
Age, Customized
Age · 65-75
|
707 Participants
n=5 Participants
|
758 Participants
n=7 Participants
|
1465 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2979 Participants
n=5 Participants
|
2940 Participants
n=7 Participants
|
5919 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2559 Participants
n=5 Participants
|
2413 Participants
n=7 Participants
|
4972 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
186 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
331 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5211 Participants
n=5 Participants
|
5149 Participants
n=7 Participants
|
10360 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
141 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
246 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
34 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
305 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
634 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4697 Participants
n=5 Participants
|
4656 Participants
n=7 Participants
|
9353 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
167 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
79 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Index visit date through 30 days post-index, inclusive.Population: Patients previously undiagnosed with OUD but identified as high risk by the OUD-CDS
Patient has an ICD10 diagnosis code for OUD assigned at an encounter or added to the problem list
Outcome measures
| Measure |
Receives OUD-CDS
n=2079 Participants
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=2074 Participants
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
Number of Patients With OUD Diagnosis
|
36 participants
|
24 participants
|
PRIMARY outcome
Timeframe: Index visit date through 30 days post-index, inclusive.Patient has a medication order for a naloxone rescue kit
Outcome measures
| Measure |
Receives OUD-CDS
n=5538 Participants
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=5353 Participants
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
Number of Patients With Naloxone Rescue Kit Order
|
80 participants
|
40 participants
|
PRIMARY outcome
Timeframe: Index visit date through 30 days post-index, inclusive.Patient has a medication order for a MOUD or referral for addiction treatment
Outcome measures
| Measure |
Receives OUD-CDS
n=5538 Participants
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=5353 Participants
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
Number of Patients With a MOUD Order or Referral
|
785 participants
|
517 participants
|
PRIMARY outcome
Timeframe: Index visit date through 90 days post-index, inclusive, with 0 days assigned if there were no MOUD orders.The sum of unique days covered by a MOUD order
Outcome measures
| Measure |
Receives OUD-CDS
n=5538 Participants
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=5353 Participants
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
Days Covered by MOUD Prescription
|
84 days
Interval 55.0 to 90.0
|
83 days
Interval 55.0 to 90.0
|
SECONDARY outcome
Timeframe: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.Outcome measures
| Measure |
Receives OUD-CDS
n=5538 Participants
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=5353 Participants
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
Emergency Department Visits Per Patient-year
pre-index
|
1.30 events per patient-year
Interval 1.11 to 1.52
|
1.37 events per patient-year
Interval 1.12 to 1.68
|
|
Emergency Department Visits Per Patient-year
post-index
|
1.06 events per patient-year
Interval 0.91 to 1.23
|
1.12 events per patient-year
Interval 0.97 to 1.47
|
SECONDARY outcome
Timeframe: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.Outcome measures
| Measure |
Receives OUD-CDS
n=5538 Participants
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=5353 Participants
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
Hospitalizations Per Patient-year
post-index
|
0.32 events per patient-year
Interval 0.29 to 0.36
|
0.33 events per patient-year
Interval 0.29 to 0.38
|
|
Hospitalizations Per Patient-year
pre-index
|
0.40 events per patient-year
Interval 0.36 to 0.44
|
0.40 events per patient-year
Interval 0.35 to 0.46
|
SECONDARY outcome
Timeframe: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.Healthcare costs for prescribed medications and clinical inpatient, emergency, and outpatient services incurred, as documented in insurance claims or clinical encounter data.
Outcome measures
| Measure |
Receives OUD-CDS
n=5538 Participants
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=5353 Participants
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
Healthcare Costs
|
-1971 dollars
Interval -3021.0 to 920.0
|
-903 dollars
Interval -2143.0 to 337.0
|
SECONDARY outcome
Timeframe: index visit through one year post-index, inclusiveOutcome measures
| Measure |
Receives OUD-CDS
n=5538 Participants
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=5353 Participants
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
All-cause Mortality Per 100 Patient-years.
|
2.79 events per 100 patient-years
Interval 2.33 to 3.35
|
2.64 events per 100 patient-years
Interval 2.23 to 3.12
|
SECONDARY outcome
Timeframe: pre: one year through one day prior to the index visit; post: index visit through one year post-index or date of death, whichever was first.Outcome measures
| Measure |
Receives OUD-CDS
n=5538 Participants
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=5353 Participants
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
Overdoses Per 100 Patient-years.
pre-index
|
4.51 events per 100 patient-years
Interval 3.69 to 5.52
|
5.32 events per 100 patient-years
Interval 4.21 to 6.73
|
|
Overdoses Per 100 Patient-years.
post-index
|
3.13 events per 100 patient-years
Interval 2.57 to 3.83
|
3.42 events per 100 patient-years
Interval 2.73 to 4.28
|
Adverse Events
Receives OUD-CDS
Serious events: 3740 serious events
Other events: 375 other events
Deaths: 270 deaths
Does Not Receive the OUD-CDS
Serious events: 3752 serious events
Other events: 413 other events
Deaths: 268 deaths
Serious adverse events
| Measure |
Receives OUD-CDS
n=5688 participants at risk
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=5509 participants at risk
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
General disorders
Emergency Visits, pre-index
|
45.6%
2591/5688 • Number of events 7519 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
46.8%
2578/5509 • Number of events 7723 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
|
General disorders
Emergency Visits, post-index
|
46.5%
2643/5688 • Number of events 9560 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
49.7%
2737/5509 • Number of events 10443 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
|
General disorders
Hospitalizations, pre-index
|
21.1%
1198/5688 • Number of events 2260 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
22.2%
1221/5509 • Number of events 2290 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
|
General disorders
Hospitalizations, post-index
|
21.9%
1248/5688 • Number of events 2784 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
23.3%
1285/5509 • Number of events 3000 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
Other adverse events
| Measure |
Receives OUD-CDS
n=5688 participants at risk
Clinics will have access to the OUD-CDS (Opioid Wizard)
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
|
Does Not Receive the OUD-CDS
n=5509 participants at risk
Clinics will not have access to the OUD-CDS (Opioid Wizard). These will be "usual care" clinics.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Overdoses, pre-index
|
3.6%
204/5688 • Number of events 277 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
4.1%
228/5509 • Number of events 326 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
|
Injury, poisoning and procedural complications
Overdoses, post-index
|
3.7%
213/5688 • Number of events 326 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
4.1%
225/5509 • Number of events 342 • pre: one year through one day prior to the index visit; post: index visit through December 31, 2023 or date of death, whichever was first, up to 33 months
The safety population included all patients who had an index visit during the accrual period. Patients who were on research exclusion lists, and thus excluded from the primary study analyses, were retained for safety analyses. Safety events were monitored via passive surveillance of EHR and healthcare claims data.
|
Additional Information
Dr. Rebecca Rossom, Co-Principal Investigator
HealthPartners Institute
Phone: 952-883-5466
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI(s) should present the study primary outcome and other results to the participating sites as soon after the analyses are completed, to ensure that participating sites have a chance to comment on the results and conclusions of the trial. The PI(s) should present primary outcome results to the Steering Committee, NIDA leadership, and the DSMB prior to publication or presentations to the public.
- Publication restrictions are in place
Restriction type: OTHER