Trial Outcomes & Findings for Technology for MAT in Primary Care - Phase 2 (NCT NCT05017272)
NCT ID: NCT05017272
Last Updated: 2025-05-06
Results Overview
Percent of participants who had positive urine screening tests for buprenorphine, opioids (heroin, synthetics, fentanyl), cocaine, methamphetamine, benzodiazepines, cannabis. During the TAU period (pre-intervention), the percentage of all patient drug screens that were positive was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
COMPLETED
NA
246 participants
Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.
2025-05-06
Participant Flow
This study utilized a non-randomized, stepped-wedge effectiveness trial design, which facilitates data collection on patient outcomes prior to the OARS intervention. Sites were purposefully selected and assigned to clusters as they were identified; one site in sequence 1, two sites in sequence 2, and one site in sequence 3. 11 PCPs were enrolled in the study but only participated in semi-structured interviews to provide their insights on the OARS intervention.
Patient TAU baseline data (pre-intervention) were collected on patient outcomes retrospectively at the time of study enrollment. These baseline data were compared to corresponding data collected after OARS implementation (post-intervention) to determine the effectiveness of OARS. Data collection occurred through EHR data review and abstraction; no information was required directly from patients for the purpose of this study.
Unit of analysis: Clinics
Participant milestones
| Measure |
Sequence 1: Months 1-4 TAU, Months 5-14 OARS Intervention
Data collected pre- and post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at the Wright Center study site.
|
Sequence 2: Months 1-7 TAU, Months 8-17 OARS Intervention
Data collected pre- and post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at the Granville Vance and On-Call Mobile study sites.
|
Sequence 3: Months 1-13 TAU, Months 14-23 OARS Intervention
Data collected pre- and post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at the Stallant Health study site.
|
|---|---|---|---|
|
Step 1: Months 1-4
STARTED
|
140 1
|
3 2
|
12 1
|
|
Step 1: Months 1-4
COMPLETED
|
140 1
|
3 2
|
12 1
|
|
Step 1: Months 1-4
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 2: Months 5-8
STARTED
|
205 1
|
8 2
|
12 1
|
|
Step 2: Months 5-8
COMPLETED
|
205 1
|
8 2
|
12 1
|
|
Step 2: Months 5-8
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 3: Months 9-12
STARTED
|
205 1
|
8 2
|
12 1
|
|
Step 3: Months 9-12
COMPLETED
|
205 1
|
8 2
|
12 1
|
|
Step 3: Months 9-12
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 4: Months 13-16
STARTED
|
205 1
|
8 2
|
22 1
|
|
Step 4: Months 13-16
COMPLETED
|
205 1
|
8 2
|
22 1
|
|
Step 4: Months 13-16
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 5: Months 17-20
STARTED
|
0 0
|
8 2
|
22 1
|
|
Step 5: Months 17-20
COMPLETED
|
0 0
|
8 2
|
22 1
|
|
Step 5: Months 17-20
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
|
Step 6: Months 21-23
STARTED
|
0 0
|
0 0
|
22 1
|
|
Step 6: Months 21-23
COMPLETED
|
0 0
|
0 0
|
22 1
|
|
Step 6: Months 21-23
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Technology for MAT in Primary Care - Phase 2
Baseline characteristics by cohort
| Measure |
Study Participants
n=235 Participants
All clinical trial participants.
|
|---|---|
|
Age, Continuous
|
37 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black or African American
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
212 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic other race
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
235 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.Population: Reliable data for 80 participants during their TAU phase was not available.
Percent of participants who had positive urine screening tests for buprenorphine, opioids (heroin, synthetics, fentanyl), cocaine, methamphetamine, benzodiazepines, cannabis. During the TAU period (pre-intervention), the percentage of all patient drug screens that were positive was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Outcome measures
| Measure |
Opioid Addiction Recovery Support (OARS)
n=235 Participants
Data collected post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at study sites.
Opioid Addiction Recovery Support Software Platform: OARS (Opioid Addiction Recovery Support) is used by providers of MAT programs to improve insight into a patient's recovery progress while promoting ownership and adherence to treatment plans. OARS also provides extensive tools to support patients with recovery from Opioid Use Disorder.
|
Treatment as Usual
n=155 Participants
Data collected at baseline before OARS in conjunction with MOUD is implemented at study sites. Reliable data for 80 participants during their TAU phase was not available.
|
|---|---|---|
|
Urine Drug Screening Test Results
Buprenorphine
|
92.3 percentage of participants positive
|
92.0 percentage of participants positive
|
|
Urine Drug Screening Test Results
Opioids (heroin, synthetics, fentanyl)
|
1.9 percentage of participants positive
|
2.0 percentage of participants positive
|
|
Urine Drug Screening Test Results
Cocaine
|
1.3 percentage of participants positive
|
1.8 percentage of participants positive
|
|
Urine Drug Screening Test Results
Methamphetamine/Amphetamines
|
0.9 percentage of participants positive
|
2.0 percentage of participants positive
|
|
Urine Drug Screening Test Results
Benzodiazepines
|
4.1 percentage of participants positive
|
1.6 percentage of participants positive
|
|
Urine Drug Screening Test Results
Cannabis
|
37.5 percentage of participants positive
|
35.8 percentage of participants positive
|
PRIMARY outcome
Timeframe: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.Population: Reported percentages were calculated by dividing the number of attended appointments by total number of appointments (appointments attended + appointment no-shows). Reliable data for 80 participants during their TAU phase was not available.
Percent of appointments scheduled and kept with Primary Care Provider. During the TAU period (pre-intervention), the percentage of attended appointments was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Outcome measures
| Measure |
Opioid Addiction Recovery Support (OARS)
n=4811 Number of appointments
Data collected post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at study sites.
Opioid Addiction Recovery Support Software Platform: OARS (Opioid Addiction Recovery Support) is used by providers of MAT programs to improve insight into a patient's recovery progress while promoting ownership and adherence to treatment plans. OARS also provides extensive tools to support patients with recovery from Opioid Use Disorder.
|
Treatment as Usual
n=1539 Number of appointments
Data collected at baseline before OARS in conjunction with MOUD is implemented at study sites. Reliable data for 80 participants during their TAU phase was not available.
|
|---|---|---|
|
Appointment Attendance
|
91.5 percentage of appointments attended
|
91.0 percentage of appointments attended
|
SECONDARY outcome
Timeframe: OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the OARS periods differ by site.Population: Reliable data for 80 participants during their TAU phase was not available.
Type of OARS mobile phone app feature accessed by patient and level of patient involvement with each feature (times viewed per week). During the OARS implementation period (post-intervention), the type of OARS mobile phone app feature accessed by patient and level of patient involvement with each feature were calculated.
Outcome measures
| Measure |
Opioid Addiction Recovery Support (OARS)
n=235 Participants
Data collected post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at study sites.
Opioid Addiction Recovery Support Software Platform: OARS (Opioid Addiction Recovery Support) is used by providers of MAT programs to improve insight into a patient's recovery progress while promoting ownership and adherence to treatment plans. OARS also provides extensive tools to support patients with recovery from Opioid Use Disorder.
|
Treatment as Usual
Data collected at baseline before OARS in conjunction with MOUD is implemented at study sites. Reliable data for 80 participants during their TAU phase was not available.
|
|---|---|---|
|
OARS Features Use
Viewed test results
|
5 times used per week
Interval 0.0 to 7.5
|
—
|
|
OARS Features Use
Viewed progress
|
1 times used per week
Interval 0.0 to 3.0
|
—
|
|
OARS Features Use
Viewed educational content
|
1 times used per week
Interval 0.0 to 2.0
|
—
|
|
OARS Features Use
Sent chat message
|
0 times used per week
Interval 0.0 to 3.0
|
—
|
|
OARS Features Use
Created journal entry
|
0 times used per week
Interval 0.0 to 1.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.ROI for a MAT provider using OARS compared to TAU. During the TAU period (pre-intervention), the ROI for MAT providers was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.Including but not limited to visits, medications filled, reminder calls, asynchronous video related to OUD care. During the TAU period (pre-intervention), the counts of services/medications received by patients were determined. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.Number of Emergency Department visits, Number of Medicaid charges, Number of inpatient stays, Number of other medications. During the TAU period (pre-intervention), healthcare utilization by patients was determined. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Outcome measures
Outcome data not reported
Adverse Events
Opioid Addiction Recovery Support (OARS)
Treatment as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Steve Jenkins
Q2i LLC Telephone: 646-660-2151 Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place