Trial Outcomes & Findings for Usability Testing for the Reward-based Technology to Improve OUD Treatment (NCT NCT05159362)
NCT ID: NCT05159362
Last Updated: 2023-05-30
Results Overview
≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
during usability sessions with participants at the time of study enrollment, 1 day
Results posted on
2023-05-30
Participant Flow
Usability testing participants: Patients: n=12, Providers: n=4; Proof-of-concept field test participants: Patients: n = 11 (1 patient participated in both usability and field test portions of the study, overall study N = 26)
Participant milestones
| Measure |
OARSCM Patients
After successful completion of usability testing (Patients: n=12, Providers: n=4), a proof-of-concept field test was completed. OARSCM patients (n = 10) received TAU procedures during enrollment (SBIRT for opioid use disorder and a warm handoff to outpatient MOUD treatment). TAU outpatient MOUD treatment consists of urine toxicology (Utox) screening, group/individual therapy, and MOUD prescription. Treatment visits are typically weekly in weeks 1-4 and taper over time. Patients earned chances for prizes, for targeted behaviors, which escalated for each targeted behavior in a row, with reset criteria. For scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with each targeted behavior in a row up to a max of 10 draws/targeted behavior. There are 18 targeted behaviors during the 4-week field test (schedule intake, complete intake, 4 opioid-negative Utox/week plus bonuses for cocaine-negative Utox, and 4 therapy/week).
Software Application: Access is granted to participants for 4 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.
|
Usability Testing Patients
After successful completion of usability testing (Patients: n=12, Providers: n=4), a proof-of-concept field test was completed. OARSCM patients (n = 10) received TAU procedures during enrollment (SBIRT for opioid use disorder and a warm handoff to outpatient MOUD treatment). TAU outpatient MOUD treatment consists of urine toxicology (Utox) screening, group/individual therapy, and MOUD prescription. Treatment visits are typically weekly in weeks 1-4 and taper over time. Patients earned chances for prizes, for targeted behaviors, which escalated for each targeted behavior in a row, with reset criteria. For scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with each targeted behavior in a row up to a max of 10 draws/targeted behavior. There are 18 targeted behaviors during the 4-week field test (schedule intake, complete intake, 4 opioid-negative Utox/week plus bonuses for cocaine-negative Utox, and 4 therapy/week).
|
Usability Testing Providers
After successful completion of usability testing (Patients: n=12, Providers: n=4), a proof-of-concept field test was completed. OARSCM patients (n = 10) received TAU procedures during enrollment (SBIRT for opioid use disorder and a warm handoff to outpatient MOUD treatment). TAU outpatient MOUD treatment consists of urine toxicology (Utox) screening, group/individual therapy, and MOUD prescription. Treatment visits are typically weekly in weeks 1-4 and taper over time. Patients earned chances for prizes, for targeted behaviors, which escalated for each targeted behavior in a row, with reset criteria. For scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with each targeted behavior in a row up to a max of 10 draws/targeted behavior. There are 18 targeted behaviors during the 4-week field test (schedule intake, complete intake, 4 opioid-negative Utox/week plus bonuses for cocaine-negative Utox, and 4 therapy/week).
|
|---|---|---|---|
|
Usability Testing (1 Day)
STARTED
|
0
|
12
|
4
|
|
Usability Testing (1 Day)
COMPLETED
|
0
|
12
|
4
|
|
Usability Testing (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
|
Field Testing (4 Weeks)
STARTED
|
11
|
0
|
0
|
|
Field Testing (4 Weeks)
COMPLETED
|
10
|
0
|
0
|
|
Field Testing (4 Weeks)
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
OARSCM Patients
After successful completion of usability testing (Patients: n=12, Providers: n=4), a proof-of-concept field test was completed. OARSCM patients (n = 10) received TAU procedures during enrollment (SBIRT for opioid use disorder and a warm handoff to outpatient MOUD treatment). TAU outpatient MOUD treatment consists of urine toxicology (Utox) screening, group/individual therapy, and MOUD prescription. Treatment visits are typically weekly in weeks 1-4 and taper over time. Patients earned chances for prizes, for targeted behaviors, which escalated for each targeted behavior in a row, with reset criteria. For scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with each targeted behavior in a row up to a max of 10 draws/targeted behavior. There are 18 targeted behaviors during the 4-week field test (schedule intake, complete intake, 4 opioid-negative Utox/week plus bonuses for cocaine-negative Utox, and 4 therapy/week).
Software Application: Access is granted to participants for 4 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.
|
Usability Testing Patients
After successful completion of usability testing (Patients: n=12, Providers: n=4), a proof-of-concept field test was completed. OARSCM patients (n = 10) received TAU procedures during enrollment (SBIRT for opioid use disorder and a warm handoff to outpatient MOUD treatment). TAU outpatient MOUD treatment consists of urine toxicology (Utox) screening, group/individual therapy, and MOUD prescription. Treatment visits are typically weekly in weeks 1-4 and taper over time. Patients earned chances for prizes, for targeted behaviors, which escalated for each targeted behavior in a row, with reset criteria. For scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with each targeted behavior in a row up to a max of 10 draws/targeted behavior. There are 18 targeted behaviors during the 4-week field test (schedule intake, complete intake, 4 opioid-negative Utox/week plus bonuses for cocaine-negative Utox, and 4 therapy/week).
|
Usability Testing Providers
After successful completion of usability testing (Patients: n=12, Providers: n=4), a proof-of-concept field test was completed. OARSCM patients (n = 10) received TAU procedures during enrollment (SBIRT for opioid use disorder and a warm handoff to outpatient MOUD treatment). TAU outpatient MOUD treatment consists of urine toxicology (Utox) screening, group/individual therapy, and MOUD prescription. Treatment visits are typically weekly in weeks 1-4 and taper over time. Patients earned chances for prizes, for targeted behaviors, which escalated for each targeted behavior in a row, with reset criteria. For scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with each targeted behavior in a row up to a max of 10 draws/targeted behavior. There are 18 targeted behaviors during the 4-week field test (schedule intake, complete intake, 4 opioid-negative Utox/week plus bonuses for cocaine-negative Utox, and 4 therapy/week).
|
|---|---|---|---|
|
Field Testing (4 Weeks)
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Usability Testing for the Reward-based Technology to Improve OUD Treatment
Baseline characteristics by cohort
| Measure |
OARSCM Patients
n=11 Participants
After successful completion of usability testing (Patients: n=12, Providers: n=4), a proof-of-concept field test was completed. OARSCM patients (n = 10) received TAU procedures during enrollment (SBIRT for opioid use disorder and a warm handoff to outpatient MOUD treatment). TAU outpatient MOUD treatment consists of urine toxicology (Utox) screening, group/individual therapy, and MOUD prescription. Treatment visits are typically weekly in weeks 1-4 and taper over time. Patients earned chances for prizes, for targeted behaviors, which escalated for each targeted behavior in a row, with reset criteria. For scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with each targeted behavior in a row up to a max of 10 draws/targeted behavior. There are 18 targeted behaviors during the 4-week field test (schedule intake, complete intake, 4 opioid-negative Utox/week plus bonuses for cocaine-negative Utox, and 4 therapy/week).
Software Application: Access is granted to participants for 4 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.
\*1 participant completed both OARSCM Patient arm and Usability Patient arm (listed only under OARSCM Patient arm here)
|
Usability Patients
n=11 Participants
After successful completion of usability testing (Patients: n=12, Providers: n=4), a proof-of-concept field test was completed. OARSCM patients (n = 10) received TAU procedures during enrollment (SBIRT for opioid use disorder and a warm handoff to outpatient MOUD treatment). TAU outpatient MOUD treatment consists of urine toxicology (Utox) screening, group/individual therapy, and MOUD prescription. Treatment visits are typically weekly in weeks 1-4 and taper over time. Patients earned chances for prizes, for targeted behaviors, which escalated for each targeted behavior in a row, with reset criteria. For scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with each targeted behavior in a row up to a max of 10 draws/targeted behavior. There are 18 targeted behaviors during the 4-week field test (schedule intake, complete intake, 4 opioid-negative Utox/week plus bonuses for cocaine-negative Utox, and 4 therapy/week).
\*1 participant completed both OARSCM Patient arm and Usability Patient arm (listed only under OARSCM Patient arm here)
|
Usability Providers
n=4 Participants
After successful completion of usability testing (Patients: n=12, Providers: n=4), a proof-of-concept field test was completed. OARSCM patients (n = 10) received TAU procedures during enrollment (SBIRT for opioid use disorder and a warm handoff to outpatient MOUD treatment). TAU outpatient MOUD treatment consists of urine toxicology (Utox) screening, group/individual therapy, and MOUD prescription. Treatment visits are typically weekly in weeks 1-4 and taper over time. Patients earned chances for prizes, for targeted behaviors, which escalated for each targeted behavior in a row, with reset criteria. For scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with each targeted behavior in a row up to a max of 10 draws/targeted behavior. There are 18 targeted behaviors during the 4-week field test (schedule intake, complete intake, 4 opioid-negative Utox/week plus bonuses for cocaine-negative Utox, and 4 therapy/week).
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 8.99 • n=5 Participants
|
32 years
STANDARD_DEVIATION 10.11 • n=7 Participants
|
35 years
STANDARD_DEVIATION 5.57 • n=5 Participants
|
33 years
STANDARD_DEVIATION 8.86 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
4 participants
n=5 Participants
|
26 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: during usability sessions with participants at the time of study enrollment, 1 day≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed
Outcome measures
| Measure |
OARSCM Usability Testing
n=12 Participants
Participants completed Usability and Acceptability Testing.
|
|---|---|
|
OARSCM Usability - Phase 1 Usability
|
12 Participants
|
PRIMARY outcome
Timeframe: during usability sessions with participants at the time of study enrollment, 1 dayAcceptability outcome will be an average System Usability Scale score of ≥ 80 (range 0-100), with higher numbers indicative of better scores
Outcome measures
| Measure |
OARSCM Usability Testing
n=12 Participants
Participants completed Usability and Acceptability Testing.
|
|---|---|
|
OARSCM Acceptability - Phase 1 Usability
|
93.2 score on a scale
Standard Deviation 7.99
|
PRIMARY outcome
Timeframe: End of 4-week field test period≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed
Outcome measures
| Measure |
OARSCM Usability Testing
n=11 Participants
Participants completed Usability and Acceptability Testing.
|
|---|---|
|
OARSCM Usability - Phase 1 Field Test
|
11 Participants
|
PRIMARY outcome
Timeframe: End of 4-week field test periodAcceptability outcome will be an average System Usability Scale score of ≥ 80 (range 0-100), with higher numbers indicative of better scores
Outcome measures
| Measure |
OARSCM Usability Testing
n=8 Participants
Participants completed Usability and Acceptability Testing.
|
|---|---|
|
OARSCM Acceptability - Phase 1 Field Test
|
78.1 score on a scale
Standard Deviation 20.78
|
Adverse Events
OARSCM
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place