OARSCM: Usability Testing for the Reward-based Technology to Improve OUD Treatment

Sponsor

Q2i, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT05159362

Collaborator

University of Massachusetts Chan Medical School (Other), National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arm

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder Contingency Management Medication for Opioid-use Disorder	Other: Software Application	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Participants were enrolled and monitored through a 4-week field test.Participants were enrolled and monitored through a 4-week field test.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Reward-based Technology to Improve Opioid Use Disorder Treatment Initiation After an ED Visit - Phase 1

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OARSCM After successful completion of usability testing (Patients: n=11, 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).	Other: Software Application Access is granted to participants for 4 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals. Other Names: Opioid Addiction Recovery Support - Contingency Management (OARSCM)

Arm

Intervention/Treatment

Experimental: OARSCM

After successful completion of usability testing (Patients: n=11, 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).

Other: Software Application

Access is granted to participants for 4 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.

Other Names:

Opioid Addiction Recovery Support - Contingency Management (OARSCM)

Outcome Measures

Primary Outcome Measures

OARSCM usability - Phase 1 Usability [1 timepoint at usability sessions with participants at the time of study enrollment]
≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed
OARSCM acceptability - Phase 1 Usability [1 timepoint at usability sessions with participants at the time of study enrollment]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥18 years old
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
Presence of a current DSM-V opioid use disorder (OUD), mild to severe
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:

Persistent altered mental status (not alert, not oriented, psychotic).
Not interested or willing to participate in Suboxone treatment
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.
Unwilling to use the OARSCM app (if assigned)
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
Currently in state custody or pending legal action that might lead to imprisonment
Cannot paraphrase the study requirements
Does not read or speak English
Does not reside in the central MA region
Already enrolled in the trial