Alcohol Use Disorder Clinical Trial
— COPEOfficial title:
The Impact of COVID-19-related Medication Assisted Treatment Policy Changes on Care and Outcomes for Patients With Opioid Use Disorder
Our nation is facing the COVID-19 pandemic during an ongoing opioid epidemic. Effective treatment for patients with opioid use problems involves a treatment method called Medication-Assisted Treatment, or MAT. In MAT, patients receive a medication that reduces cravings and withdrawal symptoms and can prevent overdose. Patients also receive counseling. Because the medications that are used in MAT are controlled substances, this treatment is subject to a number of federal regulations. The need for social-distancing during the pandemic would have made following these regulations very difficult for patients and their providers. Because of these difficulties, the federal government eased regulations in March 2020, making it easier for patients to receive MAT with fewer (if any) in-person visits for medication and counseling. Our team is studying the effects of these policy changes on the treatment that patients with opioid use disorder receive and on their outcomes. We are using both quantitative analyses of large, existing databases and qualitative analyses of interviews with patients, providers, and policy-makers to study these effects.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | August 31, 2023 |
Est. primary completion date | July 27, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Data for Aims 1 and 2 will be archival. Patients with OUD and their propensity score-matched AUD comparators will be included for Aims 1 and 2. No other patients from these larger datasets will be included. In/exclusion below pertain to Aim 3 qualitative interviews: Inclusion Criteria: - VA patients with OUD who currently, or recently (within the past 6 months) receive(d) treatment for OUD from providers within Veterans Health Administration in the states of Massachusetts, Rhode Island, or New Hampshire. - Non-Veteran patients with OUD (N=30) who currently, or recently (within the past 6 months) receive(d) treatment for OUD from providers outside Veterans Health Administration in the states of Massachusetts, Rhode Island, or New Hampshire. - VA - OUD treatment providers who currently provide treatment for OUD within Veterans Health Administration, and have been a Veterans Health Administration provider of OUD treatment for at least one year in Massachusetts, Rhode Island, or New Hampshire. - Non-VA OUD treatment providers who currently provide treatment for OUD outside of Veterans Health Administration, and have been a provider of OUD treatment for at least one year in Massachusetts, Rhode Island, or New Hampshire. - OUD treatment and policy decision-makers who currently or recently (within past 6 months) hold/held positions within federal, state, or private organizations (e.g., Veterans Health Administration, SAMHSA) in which they are responsible for making and/or influencing significant decisions regarding the OUD treatment policy and/or the manner in which these are implemented. Exclusion Criteria: - Under 18 - Inability to speak fluent English - Inability to provide a clear reporting of their experiences due to current influence of substances |
Country | Name | City | State |
---|---|---|---|
United States | VA Boston Healthcare System | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston VA Research Institute, Inc. | Boston University, International Business Machines (IBM), Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aim 1: Prescription medication access | Medication prescription fills, In-person prescribing, Telehealth prescribing for OUD and AUD (clinical comparator) | January 2019-December 2019; April 2020-March 2021 | |
Primary | Aim 1: Patient-provider encounter | In-person counseling / psychotherapy, Telehealth counseling/ psychotherapy for OUD and AUD (clinical comparator) | January 2019-December 2019; April 2020-March 2021 | |
Primary | Aim 2: Treatment retention/discontinuation | Medication treatment retention, as measured by continuous and treatment, for patients with OUD and AUD (comparator) | January 2019-December 2019; April 2020-March 2021 | |
Primary | Aim 2: Adverse outcomes | Emergency Department visits, Detoxification treatment utilization, Overdose, Death, OUD/AUD Relapse for OUD and AUD (clinical comparator) | January 2019-December 2019; April 2020-March 2021 | |
Primary | Aim 3: Semi-structured qualitative interview data from patients, providers, policy makers | [Qualitative] Patient, provider, and policy-maker perspectives regarding OUD treatment and OUD treatment policies, practices, and implementation during COVID-19 | January 2019-December 2019; April 2020-March 2021 |
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