An observational study in Opioid-use Disorder, sponsored by Q2i, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-16.
Sponsored by Q2i, LLC · Observational
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.
1,412 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 45 is below the median of 129 across 174 observational studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Q2i, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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.
Also known as: OARS
Feasibility for primary care providers (PCPs)
Frequency of days of engagement per week and use of interactive features does not reduce over 20%.
Time frame: 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%.
Time frame: 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).
Time frame: At week 4.
Acceptability for patients
No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).
Time frame: At week 4.
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.
Time frame: 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.
Time frame: At week 4.
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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