What is the research about?
Our nation is facing the COVID-19 pandemic during an ongoing opioid epidemic.
Nearly two million Americans have an opioid use disorder, which can lead to significant problems, including poor health and quality of life, overdose, and death. 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 federal regulations. These regulations have stated that MAT can only be started after a patient has a full, in-person physical examination, that only certain patients can receive doses of their medications to take home (rather than taking them at the opioid treatment clinic each day), and that patients can only receive a limited number of days of medication at a time.
The pandemic has made following these regulations very difficult for patients and providers. Patients would need to come to a healthcare center and meet face-to-face with providers frequently, increasing the risk of exposure to the virus. Because of these difficulties, the federal government eased these regulations in March 2020, making it much easier for patients to receive MAT with fewer (if any) in-person visits for medication and counseling.
Because these policy changes were put into effect quickly, in response to the COVID-19 emergency, no one has yet determined what the effect has been, or will be, on the treatment that patients with opioid use disorder receive, or on important patient outcomes, such as how long they stay in treatment, when and if they relapse, and overdose risk.
Who can this research help?
Policy makers can use findings from this study to help decide whether the new, less restrictive rules about MAT should be kept in place, even after the pandemic. Patients and healthcare providers can use the findings to help decide what kinds of treatment might be best for them.
What is the research team doing?
The researchers are using data on the healthcare claims that patients file with their insurance (private, Medicaid, or Veteran’s Health Administration; VHA) and medical record data from the VHA. They are comparing treatment and patient outcomes from 2019 (pre-United State pandemic) with that from the year after the policy changes went into effect (April 2020-March 2021). The researchers are also comparing outcomes for patients with opioid use disorders to patients with alcohol use disorder. Alcohol use disorders are also treated with counseling and often with medications, but the medications used are not controlled substances. This means that treatment for alcohol use disorder was not impacted by the federal regulation changes for MAT. Any pre- post-pandemic changes in healthcare use or patient outcomes for people with alcohol use disorders can then be attributed to the other factors (such as pandemic-related stress) and not to MAT policy changes, so this group will help researchers sort out the changes for patients with opioid use disorders that are more directly due to MAT policy changes.
The research team will also interview patients who have received treatment for opioid use disorders, healthcare providers, and policy decision-makers about how these policy changes have worked for them and/or their organizations, and about how COVID-19 has more directly affected them. For this part of the project, they are recruiting 60 patients who received MAT, 30 MAT providers, and 20 policy makers. Information from these stakeholder interviews will help inform the research design, and interpretation and dissemination of our results. Additionally, a patient advisory panel will function as an important part of the research team, guiding the questions they ask, how they ask them, how they interpret results, and how they disseminate the findings.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.