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Clinical Trials/NCT05159362
NCT05159362
Completed
Not Applicable

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

Q2i, LLC1 site in 1 country26 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid-use Disorder
Sponsor
Q2i, LLC
Enrollment
26
Locations
1
Primary Endpoint
OARSCM Usability - Phase 1 Usability
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
March 1, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Q2i, LLC
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

OARSCM Usability - Phase 1 Usability

Time Frame: 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 Usability - Phase 1 Field Test

Time Frame: 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 Usability

Time Frame: 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 Acceptability - Phase 1 Field Test

Time Frame: 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

Study Sites (1)

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