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

NCT05159362 | Completed Results

• 2 other identifiers: H00017879-1R42DA049448
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• OARSCM Usability - Phase 1 Usability

  ≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed

  during usability sessions with participants at the time of study enrollment, 1 day

• 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

  during usability sessions with participants at the time of study enrollment, 1 day

• OARSCM Usability - Phase 1 Field Test

  ≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed

  End of 4-week field test period

• 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

  End of 4-week field test period

Study Arms (1)

OARSCM

EXPERIMENTAL

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).

Other: Software Application

Interventions

Software Application OTHER

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

Also known as: Opioid Addiction Recovery Support - Contingency Management (OARSCM)

OARSCM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Q2i, LLC: lead
• University of Massachusetts, Worcester: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Links

• Webpage for OARSCM solution

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Steven Jenkins, CEO Q2i
• Organization: Q2i, LLC

sjenkins@q2i-group.com

646-660-2151

Study Officials

• Rachel Davis-Martin, PhD

  University of Massachusetts Chan Medical School

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: December 16, 2021
• Study Start: July 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 30, 2023
• Results First Posted: October 7, 2022

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available starting 6 months after publication of results.
• Access Criteria: Deidentified data will be accessible to researchers who wish to conduct analyses not reported in prior publications. The study principal investigator will review any request for data to ensure no overlapping analyses. Deidentified data will be shared via secure, HIPAA-compliant data transfers.

Locations

US (1)