Reward-Based Recovery Outcomes Management for Opioid Use Disorder

PROCare: Cloud Process Support for Opioid Recovery Participation and Learning

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: PROCare

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • South Florida Behavioral Health Network, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROCare; Technology-enabled, reward-based recovery platform	Behavioral: PROCare; 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.
No Intervention: Control; Treatment-as-Usual

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of PROCare App as Assessed by System Usability Scale (SUS)	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.	4-week

Collaborators and Investigators

• Sponsor: Medical Decision Logic, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); PRO Health Group
• Investigators: Principal Investigator: Steven L Proctor, PhD, PRO Health Group; Principal Investigator: Allen Tien, MD, Medical Decision Logic, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): September 29, 2022
• Study Completion (Actual): September 29, 2022

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2020-001; 1R43DA051298-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No