Technology for MAT in Primary Care - Phase 2

Technology Improving Success of Medication-Assisted Treatment in Primary Care - Phase 2

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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Other: Opioid Addiction Recovery Support Software Platform

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • UCLA Center for Behavioral and Addiction Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Opioid Addiction Recovery Support (OARS); 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; 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.; Other Names: OARS
No Intervention: Treatment as Usual; Data collected at baseline before OARS in conjunction with MOUD is implemented at study sites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Other Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Q2i, LLC
• Collaborators: National Institute on Drug Abuse (NIDA); University of California, Los Angeles
• Investigators: Principal Investigator: Steven J Shoptaw, PhD, University of California, Los Angeles

Publications and helpful links

Helpful Links

• Further information about the OARS solution available here.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Primary care; mHealth; Opioid use disorder; Medication for opioid use disorder; Technological solutions
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 20-001516; 4R42DA050398-02 (U.S. NIH Grant/Contract); 5R42DA050398-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No