Technology for MAT in Primary Care - Phase 2

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05017272
• Other study ID #: 20-001516
• Secondary ID: 4R42DA050398-02
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: March 2023
• Source: Q2i, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: August 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Center for Behavioral and Addiction Medicine	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Q2i, LLC	National Institute on Drug Abuse (NIDA), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Return on Investment (ROI)	ROI for a MAT provider using OARS compared to treatment as usual.	Post (OARS) intervention through to study completion, up to 10 months
Other	Counts of services/medications received by patients	Including but not limited to visits, medications filled, reminder calls, asynchronous video related to OUD care	Change from baseline treatment as usual (TAU) at post-intervention (from start of intervention through to study completion, up to 10 months)
Other	Additional healthcare utilization by patients	Number of Emergency Department visits, Number of Medicaid charges, Number of inpatient stays, Number of other medications	Change from baseline treatment as usual (TAU) at post-intervention (from start of intervention through to study completion, up to 10 months)
Primary	Number and result of urine screening tests for buprenorphine, opioids (heroin, synthetics, fentanyl), cocaine, methamphetamine, benzodiazepines, cannabis	Total	Change from baseline treatment as usual (TAU) at post-intervention (from start of intervention through to study completion, up to 10 months)
Primary	Number of visits scheduled and kept with PCP	Total	Change from baseline treatment as usual (TAU) at post-intervention (from start of intervention through to study completion, up to 10 months)
Secondary	Number of times OARS platform initiated by provider	Total and Number per week	Post (OARS) intervention through to study completion, up to 10 months
Secondary	Use of OARS risk score per patients	Yes/No	Post (OARS) intervention through to study completion, up to 10 months
Secondary	Number of visits scheduled and kept with psychosocial providers	Total	Change from baseline treatment as usual (TAU) at post-intervention (from start of intervention through to study completion, up to 10 months)
Secondary	Type of feature and level of involvement with patient mobile application features	Total and Number per week	Post (OARS) intervention through to study completion, up to 10 months
Secondary	Number of times OARS patient mobile application initiated	Total and Number per week	Post (OARS) intervention through to study completion, up to 10 months

External Links

•   Further information about the OARS solution available here.