Opioid Use Disorder
Conditions
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.
Interventions
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.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Completing Outcomes Monitoring Surveys | 4-week | Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation. |
| Percentage of Participants Fully-Adherent to Buprenorphine | 4-week | 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 | 4-week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up | 4-week | 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 | 4-week | 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. |
| Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up | 4-week | 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 | 4-week | 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. |
| Motivation as Assessed by Readiness Ruler | 4-week | 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). |
| Percentage of Participants Using Opioids | 4-week | 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) | 4-week | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usability of PROCare App as Assessed by System Usability Scale (SUS) | 4-week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PROCare Recovery Technology-enabled, reward-based recovery mobile app | 8 |
| Control Treatment-as-Usual | 5 |
| Total | 13 |
Baseline characteristics
| Characteristic | PROCare Recovery | Total | Control |
|---|---|---|---|
| Age, Continuous | 38.00 years STANDARD_DEVIATION 10.76 | 36.38 years STANDARD_DEVIATION 8.88 | 33.80 years STANDARD_DEVIATION 4.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 10 Participants | 4 Participants |
| Region of Enrollment United States | 8 participants | 13 participants | 5 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 4 |
| other Total, other adverse events | 0 / 7 | 0 / 4 |
| serious Total, serious adverse events | 0 / 7 | 0 / 4 |
Outcome results
Percentage of Participants Completing Outcomes Monitoring Surveys
Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation.
Time frame: 4-week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PROCare Recovery | Percentage of Participants Completing Outcomes Monitoring Surveys | 7 Participants |
| Control | Percentage of Participants Completing Outcomes Monitoring Surveys | 4 Participants |
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.
Time frame: 4-week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PROCare Recovery | Percentage of Participants Fully-Adherent to Buprenorphine | 6 Participants |
| Control | Percentage of Participants Fully-Adherent to Buprenorphine | 3 Participants |
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.
Time frame: 4-week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PROCare Recovery | Percentage of Participants Fully-Adherent to Care Plan | All Appointments | 4 Participants |
| PROCare Recovery | Percentage of Participants Fully-Adherent to Care Plan | Therapy Sessions | 6 Participants |
| Control | Percentage of Participants Fully-Adherent to Care Plan | All Appointments | 2 Participants |
| Control | Percentage of Participants Fully-Adherent to Care Plan | Therapy Sessions | 3 Participants |
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.
Time frame: 4-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROCare Recovery | Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up | 19.42 score on a scale | Standard Deviation 22.69 |
| Control | Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up | 16.50 score on a scale | Standard Deviation 22.13 |
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.
Time frame: 4-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROCare Recovery | Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up | 9.86 score on a scale | Standard Deviation 1.86 |
| Control | Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up | 7.50 score on a scale | Standard Deviation 5.74 |
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.
Time frame: 4-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROCare Recovery | Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up | 4.57 score on a scale | Standard Deviation 7.09 |
| Control | Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up | 1.50 score on a scale | Standard Deviation 9.88 |
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.
Time frame: 4-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROCare Recovery | Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up | 54.62 score on a scale | Standard Deviation 16.18 |
| Control | Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up | 38.44 score on a scale | Standard Deviation 25.52 |
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).
Time frame: 4-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROCare Recovery | Motivation as Assessed by Readiness Ruler | 93.49 score on a scale | Standard Deviation 6.45 |
| Control | Motivation as Assessed by Readiness Ruler | 89.31 score on a scale | Standard Deviation 13.69 |
Percentage of Participants Using Opioids
Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period.
Time frame: 4-week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PROCare Recovery | Percentage of Participants Using Opioids | 1 Participants |
| Control | Percentage of Participants Using Opioids | 1 Participants |
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).
Time frame: 4-week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PROCare Recovery | Percentage of Participants Using Other Substances (Non-opioids) | 2 Participants |
| Control | Percentage of Participants Using Other Substances (Non-opioids) | 2 Participants |
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.
Time frame: 4-week
Population: Only participants who used the PROCare Recovery app were administered the measure of app usability.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PROCare Recovery | Usability of PROCare App as Assessed by System Usability Scale (SUS) | 88.93 score on a scale | Standard Deviation 10.49 |