Clinical trial NCT05159362: Usability Testing for the Reward-based Technology to Improve OUD Treatment
Official title: Reward-based Technology to Improve Opioid Use Disorder Treatment Initiation After an ED Visit - Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Contingency Management
Medication for Opioid-use Disorder
Keywords: Substance Use Disorder
Opioid Use Disorder
Contingency Management
Medication for opioid use disorder
Medication-assisted treatment
Lead sponsor: Q2i, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Massachusetts, Worcester
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-12-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants were enrolled and monitored through a 4-week field test.
Primary purpose: 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.


Eligibility criteria: 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

Primary outcomes:
measure: OARSCM Usability - Phase 1 Usability
timeFrame: during usability sessions with participants at the time of study enrollment, 1 day
measure: OARSCM Acceptability - Phase 1 Usability
timeFrame: during usability sessions with participants at the time of study enrollment, 1 day
measure: OARSCM Usability - Phase 1 Field Test
timeFrame: End of 4-week field test period
measure: OARSCM Acceptability - Phase 1 Field Test
timeFrame: End of 4-week field test period
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Rachel Davis-Martin, PhD
role: STUDY_DIRECTOR
References: