Technology for MAT in Primary Care - Phase 2

NCT05017272 | Completed Results

• 3 other identifiers: 20-0015164R42DA050398-025R42DA050398-03
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Keywords

Opioid use disorder; Primary care; mHealth; Medication for opioid use disorder; Technological solutions

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• 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.

Other Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

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.

Other: Opioid Addiction Recovery Support Software Platform

Treatment as Usual

NO INTERVENTION

Data collected at baseline before OARS in conjunction with MOUD is implemented at study sites.

Interventions

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.

Also known as: OARS

Opioid Addiction Recovery Support (OARS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Q2i, LLC: lead
• University of California, Los Angeles: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UCLA Center for Behavioral and Addiction Medicine

Los Angeles, California, 90024, United States

Location

Related Links

• Further information about the OARS solution available here.

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

The COVID-19 pandemic affected both enrollment and clinical operations.

Results Point of Contact

• Title: Steve Jenkins
• Organization: Q2i LLC Telephone: 646-660-2151 Email: sjenkins@q2i-group.com

sjenkins@q2i-group.com

646-660-2151

Study Officials

• Steven J Shoptaw, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 23, 2021
• Study Start: May 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: August 31, 2023
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)