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OpenTrials
Completed

NCT Number: NCT05006846

Technology for MAT 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA Center for Behavioral and Addiction Medicine

Los Angeles, California, 90024, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: OARS

Primary outcomes

  1. Feasibility for primary care providers (PCPs)

    Time frame: From week 1 to week 4.

    Frequency of days of engagement per week and use of interactive features does not reduce over 20%.

  2. Feasibility for patients

    Time frame: From week 1 to week 4.

    Frequency of days of engagement per week and use of interactive features does not reduce over 20%.

  3. Acceptability for PCPs

    Time frame: At week 4.

    No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).

  4. Acceptability for patients

    Time frame: At week 4.

    No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).

Secondary outcomes

  1. System Usability Scale for providers

    Time frame: At week 4.

    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.

  2. System Usability Scale for patients

    Time frame: At week 4.

    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.

Sponsors and collaborators

Lead sponsor

Q2i, LLC

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of California, Los Angeles

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 16, 2021
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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