Technology for MAT in Primary Care - Phase 1

NCT05006846 | Completed

• 2 other identifiers: 19-0019384R42DA050398-02
• Study Type: observational
• Target: 45
• 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.

Conditions

Opioid-use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• System Usability Scale for providers

  At week 4.

• System Usability Scale for patients

  At week 4.

Study Arms (2)

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

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

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

Cohort 1; Cohort 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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).

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

Study Officials

• Steven J Shoptaw, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 16, 2021
• Study Start: February 18, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)