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Reward-Based Recovery Outcomes Management for Opioid Use Disorder

Primary Purpose

Opioid Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROCare
Sponsored by
Medical Decision Logic, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid Use Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older
  • access to internet-enabled smartphone device
  • primary DSM-5 opioid use disorder diagnosis
  • receiving medication treatment for opioid use disorder with buprenorphine
  • English language proficient

Exclusion Criteria:

  • active suicidal ideation or psychotic symptoms

Sites / Locations

  • South Florida Behavioral Health Network, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PROCare

Control

Arm Description

Technology-enabled, reward-based recovery platform

Treatment-as-Usual

Outcomes

Primary Outcome Measures

Percentage of Participants Fully-Adherent to Buprenorphine
Assessed by % of participants fully-adherent to daily doses during study period with higher values indicating greater buprenorphine adherence.
Percentage of Participants Fully-Adherent to Care Plan
Assessed by % of participants fully-adherent to weekly outpatient individual therapy visits, community-based mutual-help recovery support meetings, and other scheduled appointments attended during study period with higher values indicating greater care plan adherence.
Percentage of Participants Completing Outcomes Monitoring Surveys
Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation.

Secondary Outcome Measures

Percentage of Participants Using Opioids
Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period.
Percentage of Participants Using Other Substances (Non-opioids)
Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period for non-opioids substances (alcohol, cannabis, methamphetamine, amphetamines, cocaine, benzodiazepines).
Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up
The EUROHIS-QOL (European Health Interview Survey-Quality of Life) 8-item index is an efficient, valid, and reliable measure of four quality of life domains (physical, psychological, environmental, and social). Items are rated on a 5-point Likert-type scale and summed to produce a total quality of life score (Range: 8-40) with higher scores indicating a higher level of satisfaction with their current quality of life. Change in scores from baseline to 4-week follow-up was examined with a higher change score indicating a greater increase in participant quality of life.
Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up
OCS is a 3-item measure of opioid craving with acceptable internal consistency, reliability, and concurrent/predictive validity. Participants rate their level of craving in reference to three situations (current, past week, and high-risk environment) on a scale ranging from 0-10 to produce a total score ranging from 0-30 with higher scores indicating greater reduction in craving. Change in OCS scores from baseline to 4-week follow-up was examined to determine reductions in craving.
Motivation as Assessed by Readiness Ruler
Readiness Ruler is a valid and reliable 2-item measure of motivation and readiness to change. Participants rate their perceived "Importance" of making a change to their drug use behaviors, and their perceived "Confidence" in their ability to successfully achieve their goal (range: 0-100) with higher scores indicating greater motivation. Perceived "Importance" and "Confidence" scores are averaged to indicate a total Motivation score at 4-week follow-up (Range: 0-100).
Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up
BSCQ is an 8-item measure of self-efficacy for resisting the urge to use drugs in 8 high-risk situations based on the relapse prevention model (unpleasant emotions, physical discomfort, pleasant emotions, testing control, urges/temptations, interpersonal conflict, social pressure, and pleasant times with others). Patients rate their confidence in resisting the urge to use drugs in each of the 8 situations on a scale ranging from 0 (Not at all Confident) to 100 (Extremely Confident). Scores for each of the 8 situations are averaged to produce a total self-efficacy score (Range: 0-100). Change in scores from baseline to 4-week follow-up was examined with higher scores indicating a greater increase in self-efficacy.
Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up
Participant self-report will be used to determine frequency counts of the 11 opioid use disorder diagnostic criteria per Diagnostic & Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with higher counts indicating a greater number of symptoms/opioid-related impairment present and higher opioid use disorder severity. Total score indicating the total number of positive diagnostic criteria ranges from 0-11. Change in the number of diagnostic criteria endorsed from baseline to 4-week follow-up was examined to determine reduction in opioid-related impairment with higher scores indicating a greater reduction in symptoms over time.

Full Information

First Posted
November 19, 2020
Last Updated
March 14, 2023
Sponsor
Medical Decision Logic, Inc.
Collaborators
PRO Health Group, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04669249
Brief Title
Reward-Based Recovery Outcomes Management for Opioid Use Disorder
Official Title
PROCare: Cloud Process Support for Opioid Recovery Participation and Learning
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Decision Logic, Inc.
Collaborators
PRO Health Group, 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

5. Study Description

Brief Summary
A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PROCare
Arm Type
Experimental
Arm Description
Technology-enabled, reward-based recovery platform
Arm Title
Control
Arm Type
No Intervention
Arm Description
Treatment-as-Usual
Intervention Type
Behavioral
Intervention Name(s)
PROCare
Intervention Description
PROCare is a reward-based digital recovery management platform for individuals receiving medication treatment for opioid use disorder. Patients have the opportunity to earn both non-monetary and monetary incentives via smart debit card for a variety of clinically-indicated behaviors, including taking their medication (buprenorphine) as directed, attending clinic appointments and community-based mutual-help support group meetings, participating in routine outcomes monitoring surveys using validated measures, accessing the curated psychoeducation content library, and engaging in other recovery-oriented activities within the smartphone app.
Primary Outcome Measure Information:
Title
Percentage of Participants Fully-Adherent to Buprenorphine
Description
Assessed by % of participants fully-adherent to daily doses during study period with higher values indicating greater buprenorphine adherence.
Time Frame
4-week
Title
Percentage of Participants Fully-Adherent to Care Plan
Description
Assessed by % of participants fully-adherent to weekly outpatient individual therapy visits, community-based mutual-help recovery support meetings, and other scheduled appointments attended during study period with higher values indicating greater care plan adherence.
Time Frame
4-week
Title
Percentage of Participants Completing Outcomes Monitoring Surveys
Description
Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation.
Time Frame
4-week
Secondary Outcome Measure Information:
Title
Percentage of Participants Using Opioids
Description
Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period.
Time Frame
4-week
Title
Percentage of Participants Using Other Substances (Non-opioids)
Description
Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period for non-opioids substances (alcohol, cannabis, methamphetamine, amphetamines, cocaine, benzodiazepines).
Time Frame
4-week
Title
Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up
Description
The EUROHIS-QOL (European Health Interview Survey-Quality of Life) 8-item index is an efficient, valid, and reliable measure of four quality of life domains (physical, psychological, environmental, and social). Items are rated on a 5-point Likert-type scale and summed to produce a total quality of life score (Range: 8-40) with higher scores indicating a higher level of satisfaction with their current quality of life. Change in scores from baseline to 4-week follow-up was examined with a higher change score indicating a greater increase in participant quality of life.
Time Frame
4-week
Title
Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up
Description
OCS is a 3-item measure of opioid craving with acceptable internal consistency, reliability, and concurrent/predictive validity. Participants rate their level of craving in reference to three situations (current, past week, and high-risk environment) on a scale ranging from 0-10 to produce a total score ranging from 0-30 with higher scores indicating greater reduction in craving. Change in OCS scores from baseline to 4-week follow-up was examined to determine reductions in craving.
Time Frame
4-week
Title
Motivation as Assessed by Readiness Ruler
Description
Readiness Ruler is a valid and reliable 2-item measure of motivation and readiness to change. Participants rate their perceived "Importance" of making a change to their drug use behaviors, and their perceived "Confidence" in their ability to successfully achieve their goal (range: 0-100) with higher scores indicating greater motivation. Perceived "Importance" and "Confidence" scores are averaged to indicate a total Motivation score at 4-week follow-up (Range: 0-100).
Time Frame
4-week
Title
Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up
Description
BSCQ is an 8-item measure of self-efficacy for resisting the urge to use drugs in 8 high-risk situations based on the relapse prevention model (unpleasant emotions, physical discomfort, pleasant emotions, testing control, urges/temptations, interpersonal conflict, social pressure, and pleasant times with others). Patients rate their confidence in resisting the urge to use drugs in each of the 8 situations on a scale ranging from 0 (Not at all Confident) to 100 (Extremely Confident). Scores for each of the 8 situations are averaged to produce a total self-efficacy score (Range: 0-100). Change in scores from baseline to 4-week follow-up was examined with higher scores indicating a greater increase in self-efficacy.
Time Frame
4-week
Title
Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up
Description
Participant self-report will be used to determine frequency counts of the 11 opioid use disorder diagnostic criteria per Diagnostic & Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with higher counts indicating a greater number of symptoms/opioid-related impairment present and higher opioid use disorder severity. Total score indicating the total number of positive diagnostic criteria ranges from 0-11. Change in the number of diagnostic criteria endorsed from baseline to 4-week follow-up was examined to determine reduction in opioid-related impairment with higher scores indicating a greater reduction in symptoms over time.
Time Frame
4-week
Other Pre-specified Outcome Measures:
Title
Usability of PROCare App as Assessed by System Usability Scale (SUS)
Description
SUS is a 10-item measure commonly used for global assessments of systems usability. SUS scores will be used to objectively quantify the usability of the PROCare recovery app. Participants allocated to the PROCare condition will rate the usability of the app on 10 items assessing different aspects of usability using a Likert-type scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) with higher converted total scores indicating a higher level of overall usability. Converted total scores range from 0-100 with SUS scores above 68 considered Above Average.
Time Frame
4-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older access to internet-enabled smartphone device primary DSM-5 opioid use disorder diagnosis receiving medication treatment for opioid use disorder with buprenorphine English language proficient Exclusion Criteria: active suicidal ideation or psychotic symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L Proctor, PhD
Organizational Affiliation
PRO Health Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allen Tien, MD
Organizational Affiliation
Medical Decision Logic, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Florida Behavioral Health Network, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reward-Based Recovery Outcomes Management for Opioid Use Disorder

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