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Clinical Trial Summary

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.

Clinical Trial Description

The COVID-19 disease outbreak has occurred in the midst of a national opioid crisis, and poses significant risk for individuals with opioid use disorder (OUD). If existing in-person care delivery systems continued, patients would need to choose between risking exposure to the virus, or foregoing OUD treatment. Medication-assisted treatment (MAT), the gold-standard for treating OUD, involves daily medication (i.e., methadone or buprenorphine), close medication monitoring, and counseling sessions, all typically occurring in person. The medications used are schedule II and III controlled substances and are subject to greater federal regulations than medications for other substance use disorders (SUD), such as alcohol use disorder (AUD).3 To temper the impact of COVID-19 on OUD patients, in March 2020 the federal government temporarily, but dramatically, loosened MAT restrictions to expand treatment options, require fewer in-person visits, and prevent disruption to life-saving treatment. This rapid shift in policy created a natural experiment, allowing for the evaluation of this MAT policy intervention on OUD patient care and outcomes. To examine the unknown effects of this intervention, we propose a mixed-methods, naturalistic experimental design involving quantitative analysis of large administrative and healthcare utilization datasets to evaluate the impact of MAT policy changes on patient care and outcomes. We will also compare OUD patient outcomes to those of AUD patients (analogue comparison group), for whom treatment was unaffected by MAT policy changes. We will then conduct interviews with patients, providers, and key MAT policy stakeholders, to understand perspectives on the impact of these COVID-19 related MAT policy changes on the lives and well-being of OUD patients, and guide policy decisions regarding whether or not to make these changes permanent. Given the general impact of the COVID-19 pandemic on patients and systems, we will compare outcomes for patients with OUD to analogue AUD patients, for whom there were no comparable medication policy changes in response to COVID-19. Patients with OUD across three healthcare systems will be engaged in all steps of the research, including influencing the research design, assisting in determining key variables for Aims 1 and 2, collaborating in drafting our interview scripts for Aim 3, and assisting in interpreting our results and disseminating findings to patient stakeholders. Aim 1. Using existing datasets, examine the effect of federal regulation changes on trends in delivery of MAT for OUD before and after pandemic onset, with a particular focus on prescription access, refills, and dosing schedules, as well as rates of in-person vs. telehealth medical and counseling visits. Aim 2. Estimate the impact of the changes in OUD healthcare delivery on crucial patient outcomes (e.g., emergency department visits, detoxification, treatment retention, relapse, overdose, and mortality) by comparing patients with OUD vs. AUD (clinical analogue comparison group), across time (pre- and post-MAT policy changes). Aim 3. Through in-depth, qualitative interviews and analyses, characterize patient, provider, and decision-maker perspectives on the impact of MAT policy changes in response to COVID-19 on patient access to MAT, health, functioning, and well-being. Built-in reporting milestones will expedite data sharing to guide policy, provider, and patient decision-making as health care systems determine how to prepare for future pandemics, and post-COVID-19 pandemic care for OUD patients. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05028998
Study type Observational
Source Boston VA Research Institute, Inc.
Contact Risa Weisberg, PhD
Phone 857-364-4035
Email [email protected]
Status Not yet recruiting
Start date September 1, 2021
Completion date January 2023

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