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| ID | Type | Description | Link |
|---|---|---|---|
| 4R42DA050398-02 | U.S. NIH Grant/Contract | View source | |
| 5R42DA050398-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Addiction Recovery Support (OARS) | Active Comparator | Data collected post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at study sites. |
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| Treatment as Usual | No Intervention | Data collected at baseline before OARS in conjunction with MOUD is implemented at study sites. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Addiction Recovery Support Software Platform | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the OARS periods differ by site. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
Inclusion Criteria:
For Primary Care Providers (PCPs):
For Patient participants:
Exclusion Criteria:
For PCPs:
For Patient participants:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Shoptaw, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Center for Behavioral and Addiction Medicine | Los Angeles | California | 90024 | United States |
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| Label | URL |
|---|---|
| Further information about the OARS solution available here. | View source |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Months 1-4 TAU, Months 5-14 OARS Intervention | Data collected pre- and post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at the Wright Center study site. |
| FG001 | Sequence 2: Months 1-7 TAU, Months 8-17 OARS Intervention | Data collected pre- and post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at the Granville Vance and On-Call Mobile study sites. |
| FG002 | Sequence 3: Months 1-13 TAU, Months 14-23 OARS Intervention | Data collected pre- and post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at the Stallant Health study site. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Step 1: Months 1-4 |
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| Step 2: Months 5-8 |
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| Step 3: Months 9-12 |
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| Step 4: Months 13-16 |
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| Step 5: Months 17-20 |
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| Step 6: Months 21-23 |
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This study utilized a retrospective cohort-style, step-wedged trial design, which was based on cohort sampling (i.e., the same patients in each sequence were followed in each step from TAU to OARS). Patient Baseline Characteristic data were collected when participants started OARS.
11 PCPs were enrolled in the study but only participated in semi-structured interviews to provide their insights on the OARS intervention. No other data was captured for PCPs.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | All clinical trial participants. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Reliable data for 80 participants during their TAU phase was not available. | Posted | Number | percentage of participants positive | 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. |
|
2 years.
11 PCPs were enrolled in the study but only participated in semi-structured interviews to provide their insights on the OARS intervention. All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed for PCPs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Opioid Addiction Recovery Support (OARS) | Data collected post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at study sites. Opioid Addiction Recovery Support Software Platform: 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. |
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The COVID-19 pandemic affected both enrollment and clinical operations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Jenkins | Q2i LLC Telephone: 646-660-2151 Email: sjenkins@q2i-group.com | 646-660-2151 | sjenkins@q2i-group.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2020 | Jan 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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| 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). | 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. |
| 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). | 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. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Treatment as Usual | Data collected at baseline before OARS in conjunction with MOUD is implemented at study sites. Reliable data for 80 participants during their TAU phase was not available. |
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| 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). | 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. | Posted | Number | percentage of appointments attended | 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 appointments | Number of appointments |
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| 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. | Reliable data for 80 participants during their TAU phase was not available. | Posted | Median | Full Range | times used per week | OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the OARS periods differ by site. |
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| 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). | Not Posted | 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. | Participants |
| 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). | Not Posted | 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. | Participants |
| 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). | Not Posted | 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. | Participants |
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| 235 |
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| EG001 | Treatment as Usual | Data collected at baseline before OARS in conjunction with MOUD is implemented at study sites. | 0 | 155 | 0 | 155 | 0 | 155 |
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