Opioid-use Disorder
Conditions
Keywords
Opioid use disorder, Primary care, mHealth, Medication for opioid use disorder, Technological solutions
Brief summary
With over 72,000 overdose deaths in 2017, of which 47,600 are attributable to opioid overdose, the opioid epidemic has become North America's most widespread behavioral public health problem. Medication-assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious. The Opioid Addiction Recovery Support (OARS), comprised of a healthcare team portal connected to a patient mobile application, provides opioid-related education, promotes connectedness with clinicians, and tracks MAT treatment progress. This study will conduct interviews with patients that will inform optimal design of OARS, assess the efficacy of OARS in improving MAT outcomes in primary care settings, and evaluate the sustainability and return on investment. It joins an outstanding scientific team at University of California, Los Angeles and a small business that has developed, Opioid Addiction Recovery Support (OARS) -- a software platform that by integrating with the Electronic Health Record (EHR) improves clinical management of patients by primary care providers (PCPs) treating patients with OUD using MAT. OARS platform uses a dashboard to show the real-time measurement of patient achievements in recovery. It provides opportunities for patients to interact with their PCPs, allowing for better connection to and support from their PCPs. OARS platform features artificial intelligence to analyze information from the EHR and from patients to provide a relapse risk assessment for patients receiving MAT for OUD, an innovation that sets OARS apart from other software solutions. The goal of Phase 1 was to modify the OARS platform for use in primary care settings by conducting interviews with Primary Care Physicians (PCPs) (N=20) and their patients with OUD (N=40) in primary care settings to collect data on feasibility and acceptability of engaging with OARS to inform the user-centered design of OARS. The goals of Phase 2 of this study are to: (1) to assess the effectiveness of OARS in improving opioid agonist treatment outcomes across 6 treatment programs (N=200 treated patients) and (2) evaluate the sustainability and return on investment of OARS implementation across 6 treatment programs. A commercialization plan documents progress to date for the OARS platform and presents a market plan to improve both the scale and quality of MAT services delivered by PCPs in primary care, which is a major contribution to addressing the ongoing opioid epidemic.
Interventions
OARS (Opioid Addiction Recovery Support) is used by providers of MAT programs to improve insight into a patient's recovery progress while promoting ownership and adherence to treatment plans. OARS also provides extensive tools to support patients with recovery from Opioid Use Disorder.
Sponsors
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Q2i, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Using a stepped wedge effectiveness design, evaluate OARS platform in 6 treatment programs (N=200 treated patients) data before and after implementation along MAT outcomes. Each clinic, once randomized to begin using OARS, will have a minimum of 4 months and a maximum of 12 months to collect baseline data on the number of PCPs who have DATA-2000 waivers, on the number of patients each PCP treats and on relevant patient outcomes to MAT (e.g., length of time in treatment, visits kept with PCP and psychosocial providers, number of drug-free urine tests). There will be four months of baseline data available for PCPs and patients defined as treatment as usual (TAU) for clinics 1 and 2, eight months of baseline data available for PCPs and patients defined as TAU for clinics 3 and 4 and 12 months of baseline data available for PCPs and patients defined as TAU for clinics 5 and 6. In the final 3 months, we will finish data analyses, prepare papers for dissemination in peer-reviewed journals.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* For Primary Care Providers (PCPs): * Physician, nurse practitioner, or physician's assistant in any area within primary care; * In possession of valid DATA-2000 waiver; * Currently treating more than two patients with OUD using oral buprenorphine-naloxone product; * Willing to distribute study materials to their patients describing the research and providing options for their participation. * For Patient participants: * Diagnosed and treated using MAT within primary care setting (i.e., family medicine, internal medicine, adolescent medicine, pediatrics, obstetrics/gynecology, geriatrics, infectious diseases, emergency department, non-cancer pain management).
Exclusion criteria
* For PCPs: * Specialization outside primary care (e.g., psychiatry, neurology, etc) or provider works in specialized setting (e.g., addiction treatment programs; mental health clinic); * Not treating patients with OUD with oral buprenorphine-naloxone product (e.g., long-acting naltrexone or buprenorphine injections); * Individual interviews with physicians and their patients to discuss initially barriers and challenges to MAT for patients with OUD seen in primary care settings. * For Patient participants: * MAT delivered in specialty care settings (i.e., psychiatry, substance abuse treatment programs).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Drug Screening Test Results | Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site. | Percent of participants who had positive urine screening tests for buprenorphine, opioids (heroin, synthetics, fentanyl), cocaine, methamphetamine, benzodiazepines, cannabis. During the TAU period (pre-intervention), the percentage of all patient drug screens that were positive was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline). |
| Appointment Attendance | Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site. | Percent of appointments scheduled and kept with Primary Care Provider. During the TAU period (pre-intervention), the percentage of attended appointments was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OARS Features Use | OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the OARS periods differ by site. | Type of OARS mobile phone app feature accessed by patient and level of patient involvement with each feature (times viewed per week). During the OARS implementation period (post-intervention), the type of OARS mobile phone app feature accessed by patient and level of patient involvement with each feature were calculated. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Return on Investment (ROI) | Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site. | ROI for a MAT provider using OARS compared to TAU. During the TAU period (pre-intervention), the ROI for MAT providers was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline). |
| Counts of Services/Medications Received by Patients | Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site. | Including but not limited to visits, medications filled, reminder calls, asynchronous video related to OUD care. During the TAU period (pre-intervention), the counts of services/medications received by patients were determined. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline). |
| Additional Healthcare Utilization by Patients | Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site. | Number of Emergency Department visits, Number of Medicaid charges, Number of inpatient stays, Number of other medications. During the TAU period (pre-intervention), healthcare utilization by patients was determined. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline). |
Countries
United States
Participant flow
Recruitment details
This study utilized a non-randomized, stepped-wedge effectiveness trial design, which facilitates data collection on patient outcomes prior to the OARS intervention. Sites were purposefully selected and assigned to clusters as they were identified; one site in sequence 1, two sites in sequence 2, and one site in sequence 3. 11 PCPs were enrolled in the study but only participated in semi-structured interviews to provide their insights on the OARS intervention.
Pre-assignment details
Patient TAU baseline data (pre-intervention) were collected on patient outcomes retrospectively at the time of study enrollment. These baseline data were compared to corresponding data collected after OARS implementation (post-intervention) to determine the effectiveness of OARS. Data collection occurred through EHR data review and abstraction; no information was required directly from patients for the purpose of this study.
Participants by arm
| Arm | Count |
|---|---|
| Study Participants All clinical trial participants. | 235 |
| Total | 235 |
Baseline characteristics
| Characteristic | Study Participants |
|---|---|
| Age, Continuous | 37 years |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black or African American | 10 Participants |
| Race/Ethnicity, Customized Non-Hispanic other race | 8 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 212 Participants |
| Region of Enrollment United States | 235 participants |
| Sex: Female, Male Female | 88 Participants |
| Sex: Female, Male Male | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 235 | 0 / 155 |
| other Total, other adverse events | 0 / 235 | 0 / 155 |
| serious Total, serious adverse events | 0 / 235 | 0 / 155 |
Outcome results
Primary
Appointment Attendance
Percent of appointments scheduled and kept with Primary Care Provider. During the TAU period (pre-intervention), the percentage of attended appointments was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Time frame: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.
Population: Reported percentages were calculated by dividing the number of attended appointments by total number of appointments (appointments attended + appointment no-shows).~Reliable data for 80 participants during their TAU phase was not available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Opioid Addiction Recovery Support (OARS) | Appointment Attendance | 91.5 percentage of appointments attended |
| Treatment as Usual | Appointment Attendance | 91.0 percentage of appointments attended |
Primary
Urine Drug Screening Test Results
Percent of participants who had positive urine screening tests for buprenorphine, opioids (heroin, synthetics, fentanyl), cocaine, methamphetamine, benzodiazepines, cannabis. During the TAU period (pre-intervention), the percentage of all patient drug screens that were positive was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Time frame: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.
Population: Reliable data for 80 participants during their TAU phase was not available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Opioid Addiction Recovery Support (OARS) | Urine Drug Screening Test Results | Opioids (heroin, synthetics, fentanyl) | 1.9 percentage of participants positive |
| Opioid Addiction Recovery Support (OARS) | Urine Drug Screening Test Results | Methamphetamine/Amphetamines | 0.9 percentage of participants positive |
| Opioid Addiction Recovery Support (OARS) | Urine Drug Screening Test Results | Buprenorphine | 92.3 percentage of participants positive |
| Opioid Addiction Recovery Support (OARS) | Urine Drug Screening Test Results | Cocaine | 1.3 percentage of participants positive |
| Opioid Addiction Recovery Support (OARS) | Urine Drug Screening Test Results | Cannabis | 37.5 percentage of participants positive |
| Opioid Addiction Recovery Support (OARS) | Urine Drug Screening Test Results | Benzodiazepines | 4.1 percentage of participants positive |
| Treatment as Usual | Urine Drug Screening Test Results | Cannabis | 35.8 percentage of participants positive |
| Treatment as Usual | Urine Drug Screening Test Results | Buprenorphine | 92.0 percentage of participants positive |
| Treatment as Usual | Urine Drug Screening Test Results | Opioids (heroin, synthetics, fentanyl) | 2.0 percentage of participants positive |
| Treatment as Usual | Urine Drug Screening Test Results | Cocaine | 1.8 percentage of participants positive |
| Treatment as Usual | Urine Drug Screening Test Results | Methamphetamine/Amphetamines | 2.0 percentage of participants positive |
| Treatment as Usual | Urine Drug Screening Test Results | Benzodiazepines | 1.6 percentage of participants positive |
Secondary
OARS Features Use
Type of OARS mobile phone app feature accessed by patient and level of patient involvement with each feature (times viewed per week). During the OARS implementation period (post-intervention), the type of OARS mobile phone app feature accessed by patient and level of patient involvement with each feature were calculated.
Time frame: OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the OARS periods differ by site.
Population: Reliable data for 80 participants during their TAU phase was not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Opioid Addiction Recovery Support (OARS) | OARS Features Use | Viewed test results | 5 times used per week |
| Opioid Addiction Recovery Support (OARS) | OARS Features Use | Viewed progress | 1 times used per week |
| Opioid Addiction Recovery Support (OARS) | OARS Features Use | Viewed educational content | 1 times used per week |
| Opioid Addiction Recovery Support (OARS) | OARS Features Use | Sent chat message | 0 times used per week |
| Opioid Addiction Recovery Support (OARS) | OARS Features Use | Created journal entry | 0 times used per week |
Other Pre-specified
Additional Healthcare Utilization by Patients
Number of Emergency Department visits, Number of Medicaid charges, Number of inpatient stays, Number of other medications. During the TAU period (pre-intervention), healthcare utilization by patients was determined. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Time frame: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.
Other Pre-specified
Counts of Services/Medications Received by Patients
Including but not limited to visits, medications filled, reminder calls, asynchronous video related to OUD care. During the TAU period (pre-intervention), the counts of services/medications received by patients were determined. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Time frame: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.
Other Pre-specified
Return on Investment (ROI)
ROI for a MAT provider using OARS compared to TAU. During the TAU period (pre-intervention), the ROI for MAT providers was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Time frame: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.