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Technology for MAT in Primary Care - Phase 1

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05006846
Enrollment
45
Registered
2021-08-16
Start date
2020-02-18
Completion date
2020-08-31
Last updated
2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-use Disorder

Keywords

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

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.

Interventions

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.

Sponsors

University of California, Los Angeles
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Q2i, LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Feasibility for primary care providers (PCPs)From week 1 to week 4.Frequency of days of engagement per week and use of interactive features does not reduce over 20%.
Feasibility for patientsFrom week 1 to week 4.Frequency of days of engagement per week and use of interactive features does not reduce over 20%.
Acceptability for PCPsAt week 4.No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).
Acceptability for patientsAt week 4.No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).

Secondary

MeasureTime frameDescription
System Usability Scale for providersAt 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.
System Usability Scale for patientsAt 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026