Technology for MAT in Primary Care - Phase 1

Technology Improving Success of Medication-Assisted Treatment in Primary Care - Phase 1

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 45

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
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The primary care providers (PCPs) willing to prescribe buprenorphine-naloxone and willing to allow two of their patients with OUD to participate were recruited through mailed recruitment flyers and by reaching out to individual clinics.

Patients were recruited through their PCP, with a maximum of two patients per PCPs participating in the study using passive recruitment of patients via email describing the study which is used so that potential patient participants can elect to or not engage in this research project independent of their PCPs decisions. Recruitment materials clarified that patients' decisions regarding research participation did in no way impact patients' clinical care. Patients whose PCPs elected not to participate in this research were also not eligible to participate.

Description

Inclusion Criteria:

• For PCPs: (1) physician, nurse practitioner, or physician's assistant in any area within primary care; (2) in possession of valid DATA-2000 waiver; (3) currently treating more than two patients with OUD using oral buprenorphine-naloxone product; (4) willing to distribute study materials to their patients describing the research and providing options for their participation.
• For patient participants: (1) 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: (1) specialization outside primary care (e.g., psychiatry, neurology, etc) or provider works in specialized setting (e.g., addiction treatment programs; mental health clinic); (2) not treating patients with OUD with oral buprenorphine-naloxone product (e.g., long-acting naltrexone or buprenorphine injections); (3) 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: (1) MAT delivered in specialty care settings (i.e., psychiatry, substance abuse treatment programs).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Primary care physicians (PCPs) and their patients used the intervention (OARS) for 4 weeks. They completed 2 interviews to obtain their feedback on the acceptability and feasibility of using OARS in a primary care setting. Data for this cohort was collected between February 18, 2020, to May 25, 2020.	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
Cohort 2; Primary care physicians (PCPs) and their patients used the intervention (OARS) for 4 weeks. They completed 2 interviews to obtain their feedback on the acceptability and feasibility of using OARS in a primary care setting. Data for this cohort was collected between July 17, 2020, to August 31, 2020.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility for primary care providers (PCPs)	Frequency of days of engagement per week and use of interactive features does not reduce over 20%.	From week 1 to week 4.
Feasibility for patients	Frequency of days of engagement per week and use of interactive features does not reduce over 20%.	From week 1 to week 4.
Acceptability for PCPs	No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).	At week 4.
Acceptability for patients	No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).	At week 4.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale for providers	The System Usability Scale (SUS) is a tool for measuring the usability, consisting of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.	At week 4.
System Usability Scale for patients	The System Usability Scale (SUS) is a tool for measuring the usability, consisting of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.	At week 4.

Collaborators and Investigators

• Sponsor: Q2i, LLC
• Collaborators: National Institute on Drug Abuse (NIDA); 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): February 18, 2020
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (ACTUAL): August 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

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: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related 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: 19-001938; 4R42DA050398-02 (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