Reward-Based Recovery Outcomes Management for Opioid Use Disorder

Study Overview
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Brief Summary
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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.

Official Title
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PROCare: Cloud Process Support for Opioid Recovery Participation and Learning

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Behavioral: PROCare


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROCare<br>Technology-enabled, reward-based recovery platform | Behavioral: PROCare<br>* 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.<br>|
| No Intervention: Control<br>Treatment-as-Usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4-week | 
| 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. | 4-week | 
| Percentage of Participants Completing Outcomes Monitoring Surveys | Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation. | 4-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Using Opioids | Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period. | 4-week | 
| 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). | 4-week | 
| 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. | 4-week | 
| 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. | 4-week | 
| 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). | 4-week | 
| 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. | 4-week | 
| 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. | 4-week |