Contingency Management, Medication for Opioid-use Disorder, Opioid-use Disorder
Conditions
Keywords
Substance Use Disorder, Opioid Use Disorder, Contingency Management, Medication for opioid use disorder, Medication-assisted treatment
Brief summary
Millions of people in the US misuse opioids each year, leading to thousands of deaths and costing billions of dollars in total economic burden. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common and associated with poor outcomes. This STTR Fast Track proposal is designed to increase rates of Suboxone (buprenorphine/naloxone) treatment initiation and adherence among OUD patients recruited from emergency and inpatient acute care. To accomplish these aims, the project will enhance the Opioid Addiction Recovery Support (OARS), an existing Q2i company technology, with a new evidence-based reward, contingency management (CM) function. CM interventions systematically reward (reinforce) specific behaviors like treatment initiation and adherence with therapy attendance and drug-free urine tests and are highly efficacious. An OARS solution enhanced with a CM component (OARSCM) that allows for the automatic calculation, delivery, and redemption of rewards contingent on objective evidence of treatment behaviors may be key to improving Suboxone initiation and adherence. In Phase 1 of this proposal, the existing OARS clinician portal and patient mobile application will be modified to accommodate entry into the software system from an acute care setting and to automatically manage and deliver rewards to create OARSCM using patient-centered design principles. Focus groups with OUD patients and other key stakeholders will inform design. Primary usability outcomes will be examined, and the program iteratively updated. After meeting milestones, there was a proof-of-concept pilot of usability, acceptability, and effects on initial behavior targets with approximately 20 patients and at least 4 providers.
Interventions
OTHERSoftware Application
Access is granted to participants for 4 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.
Sponsors
University of Massachusetts, Worcester
National Institute on Drug Abuse (NIDA)
Q2i, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were enrolled and monitored through a 4-week field test.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old 2. Presenting for acute care at UMass University and Memorial hospitals, including EDs, inpatient medical units, or inpatient behavioral health units for opioid addiction related health complaints, including opioid overdose, opioid related medical consequences, opioid intoxication or withdrawal syndromes, and/or seeking help for OUD 3. Presence of a current DSM-V opioid use disorder (OUD), mild to severe 4. Medically appropriate for outpatient Suboxone treatment, as judged by the treating clinician and behavioral health consultant or toxicologist working with the patient clinically
Exclusion criteria
1. Persistent altered mental status (not alert, not oriented, psychotic). 2. Not interested or willing to participate in Suboxone treatment 3. Best referral site is NOT one of the study's partner clinics in the central MA region, which will be outpatient MAT clinics and primary care within the UMass system and the three other primary facilities outside of the UMass system. 4. Unwilling to use the OARSCM app (if assigned) 5. Does not have access to their own smartphone with at least iOS 7.1 or Android 4.2, the minimal technology required to run the app, or not willing to access clinic-dedicated computer to access the program 6. Currently in state custody or pending legal action that might lead to imprisonment 7. Cannot paraphrase the study requirements 8. Does not read or speak English 9. Does not reside in the central MA region 10. Already enrolled in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OARSCM Usability - Phase 1 Usability | 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 |
| OARSCM Acceptability - Phase 1 Usability | during usability sessions with participants at the time of study enrollment, 1 day | Acceptability outcome will be an average System Usability Scale score of ≥ 80 (range 0-100), with higher numbers indicative of better scores |
| OARSCM Usability - Phase 1 Field Test | 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 |
| OARSCM Acceptability - Phase 1 Field Test | End of 4-week field test period | Acceptability outcome will be an average System Usability Scale score of ≥ 80 (range 0-100), with higher numbers indicative of better scores |
Countries
United States
Participant flow
Recruitment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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.
\*1 participant completed both OARSCM Patient arm and Usability Patient arm (listed only under OARSCM Patient arm here) | 11 |
| Usability 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).
\*1 participant completed both OARSCM Patient arm and Usability Patient arm (listed only under OARSCM Patient arm here) | 11 |
| Usability 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). | 4 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Field Testing (4 Weeks) | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | OARSCM Patients | Total | Usability Providers | Usability Patients |
|---|---|---|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 8.99 | 33 years STANDARD_DEVIATION 8.86 | 35 years STANDARD_DEVIATION 5.57 | 32 years STANDARD_DEVIATION 10.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 24 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 22 Participants | 3 Participants | 10 Participants |
| Region of Enrollment United States | 11 participants | 26 participants | 4 participants | 11 participants |
| Sex: Female, Male Female | 1 Participants | 9 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 17 Participants | 1 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
OARSCM Acceptability - Phase 1 Field Test
Acceptability outcome will be an average System Usability Scale score of ≥ 80 (range 0-100), with higher numbers indicative of better scores
Time frame: End of 4-week field test period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OARSCM Usability Testing | OARSCM Acceptability - Phase 1 Field Test | 78.1 score on a scale | Standard Deviation 20.78 |
Primary
OARSCM Acceptability - Phase 1 Usability
Acceptability outcome will be an average System Usability Scale score of ≥ 80 (range 0-100), with higher numbers indicative of better scores
Time frame: during usability sessions with participants at the time of study enrollment, 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OARSCM Usability Testing | OARSCM Acceptability - Phase 1 Usability | 93.2 score on a scale | Standard Deviation 7.99 |
Primary
OARSCM Usability - Phase 1 Field Test
≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed
Time frame: End of 4-week field test period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OARSCM Usability Testing | OARSCM Usability - Phase 1 Field Test | 11 Participants |
Primary
OARSCM Usability - Phase 1 Usability
≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed
Time frame: during usability sessions with participants at the time of study enrollment, 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OARSCM Usability Testing | OARSCM Usability - Phase 1 Usability | 12 Participants |