Reward-Based Recovery Outcomes Management for Opioid Use Disorder

Opioid Use Disorder Clinical Trial

Official title:

PROCare: Cloud Process Support for Opioid Recovery Participation and Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669249
• Other study ID #: 2020-001
• Secondary ID: 1R43DA051298-01A
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 29, 2022

Study information

• Verified date: November 2022
• Source: Medical Decision Logic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 29, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	South Florida Behavioral Health Network, Inc.	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Medical Decision Logic, Inc.	National Institute on Drug Abuse (NIDA), PRO Health Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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