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OpenTrials
Completed

NCT Number: NCT05159362

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

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Contingency Management Medication for Opioid-use Disorder Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Software Application

Other

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)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Q2i, LLC

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Massachusetts, Worcester

Registry information

Official study title

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

Acronym: OARSCM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2021
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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