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

Q2i

Status: Completed

Conditions: Opioid-use Disorder; Medication for Opioid-use Disorder; Contingency Management

Treatments: Other: Software Application

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05159362

H00017879-1

R42DA049448 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

26 participants in 1 patient group

OARSCM

Experimental group

Description:

After successful completion of usability testing (Patients: n=12, Providers: n=4), a proof-of-concept field test was completed. OARSCM patients (n = 11) 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).

Treatment:

Other: Software Application