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

Primary Purpose

Opioid-use Disorder, Contingency Management, Medication for Opioid-use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Software Application
Sponsored by
Q2i, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring Substance Use Disorder, Opioid Use Disorder, Contingency Management, Medication for opioid use disorder, Medication-assisted treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UMass Chan Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OARSCM

Arm 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).

Outcomes

Primary Outcome Measures

OARSCM Usability - Phase 1 Usability
≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed
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
OARSCM Usability - Phase 1 Field Test
≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed
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

Secondary Outcome Measures

Full Information

First Posted
October 20, 2021
Last Updated
May 25, 2023
Sponsor
Q2i, LLC
Collaborators
University of Massachusetts, Worcester, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05159362
Brief Title
Usability Testing for the Reward-based Technology to Improve OUD Treatment
Acronym
OARSCM
Official Title
Reward-based Technology to Improve Opioid Use Disorder Treatment Initiation After an ED Visit - Phase 1
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Q2i, LLC
Collaborators
University of Massachusetts, Worcester, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants were enrolled and monitored through a 4-week field test.
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OARSCM
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
Software Application
Other Intervention Name(s)
Opioid Addiction Recovery Support - Contingency Management (OARSCM)
Intervention Description
Access is granted to participants for 4 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.
Primary Outcome Measure Information:
Title
OARSCM Usability - Phase 1 Usability
Description
≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed
Time Frame
during usability sessions with participants at the time of study enrollment, 1 day
Title
OARSCM Acceptability - Phase 1 Usability
Description
Acceptability outcome will be an average System Usability Scale score of ≥ 80 (range 0-100), with higher numbers indicative of better scores
Time Frame
during usability sessions with participants at the time of study enrollment, 1 day
Title
OARSCM Usability - Phase 1 Field Test
Description
≥ 3 participants in a row use the program without staff assistance and no more substantive improvements are needed
Time Frame
End of 4-week field test period
Title
OARSCM Acceptability - Phase 1 Field Test
Description
Acceptability outcome will be an average System Usability Scale score of ≥ 80 (range 0-100), with higher numbers indicative of better scores
Time Frame
End of 4-week field test period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Davis-Martin, PhD
Organizational Affiliation
University of Massachusetts Chan Medical School
Official's Role
Study Director
Facility Information:
Facility Name
UMass Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share all individual participant data (IPD) that underlie published results.
IPD Sharing Time Frame
Data will be available starting 6 months after publication of results.
IPD Sharing 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.
Links:
URL
https://q2i.com/oars-cm/
Description
Webpage for OARSCM solution

Learn more about this trial

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

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