Opioid-use DisorderNCT05006846
Technology for MAT in Primary Care - Phase 1
An observational study of Opioid-use Disorder, run by Q2i, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Opioid Addiction Recovery Support Software Platform
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Behavioral and Addiction Medicine
Los Angeles, California, 90024
About this study
Official title: Technology Improving Success of Medication-Assisted Treatment 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.
- Conditions
- Opioid-use Disorder
- Being tested
- Opioid Addiction Recovery Support Software Platform
- Keywords
- Opioid use disorder, Primary care, Technological solutions, Medication for opioid use disorder, mHealth
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Addiction Recovery Support Software PlatformOther
Also called OARS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Opioid Addiction Recovery Support Software Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility for primary care providers (PCPs)
Frequency of days of engagement per week and use of interactive features does not reduce over 20%.
Measured: 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%.
Measured: 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).
Measured: At week 4.
Acceptability for patients
No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).
Measured: At week 4.
Secondary outcomes (2)
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.
Measured: 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.
Measured: At week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start18 Feb 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Q2i, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Steven J Shoptaw, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006846
- Sponsor's protocol ID
- 19-001938
- Other IDs
- 4R42DA050398-02
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Improving Success of Medication-Assisted Treatment in Primary Care - Phase 1
- ClinicalTrials.gov ID
- NCT05006846
- Acronym / sponsor ID
- 19-001938
- Conditions
- Opioid-use Disorder
- Keywords
- Opioid use disorder, Primary care, Technological solutions, Medication for opioid use disorder, mHealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Q2i, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, National Institute on Drug Abuse (NIDA)
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Opioid Addiction Recovery Support Software PlatformPrimary 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. |
| Cohort 2 | – | Other: Opioid Addiction Recovery Support Software PlatformPrimary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Addiction Recovery Support Software PlatformAlso: OARSOARS (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 | Cohort 1, Cohort 2 |
Primary outcome
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%.
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%.
Acceptability for PCPs
Time frame: At week 4.
No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).
Acceptability for patients
Time frame: At week 4.
No more than 20% of qualitative mentions that describe barriers or dissatisfactions with using OARS platform).
2 secondary outcomes
System Usability Scale for providers
Time frame: At week 4.
System Usability Scale for patients
Time frame: At week 4.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Further information about the OARS solution available here.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven J Shoptaw, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder, run by Q2i, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility for primary care providers (PCPs) (time frame: From week 1 to week 4.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.