The study, known as Home vs. Office for Medication Enhanced Recovery, or HOMER, is a partnership between the AAFP NRN, the University of Colorado-Denver and the State Network of Colorado Ambulatory Practices and Partners, and is funded by the Patient-Centered Outcomes Research Institute. Findings will help determine which practice and patient characteristics make patients the best types of candidates for each method, and will provide much-needed evidence on the most effective ways of using MAT to treat OUD in the primary care setting.
“This is a great study to help primary care take the lead in adding crucial information to overcoming the opioid epidemic in our communities,” said Jack Westfall, M.D., M.P.H., director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care in Washington, D.C., and a co-investigator for the HOMER project. “This will help create new evidence that others in family medicine will be able to use.”
According to the National Institute on Drug Abuse, about a quarter of all patients who are prescribed opioids for chronic pain misuse them, and up to 12% develop an opioid use disorder. While evidence suggests there has been a slight decline in drug overdose death rates involving prescription opioids and all opioids, opioids were still involved in nearly 47,000 drug overdose deaths in 2018.
MAT, either as stand-alone care or in combination with counseling and behavioral therapies, has been shown to be effective in treating substance use disorders such as OUD. Medications such as buprenorphine, methadone and naltrexone often are used to treat opioid dependence and help patients achieve recovery, while naloxone is used to quickly reverse instances of opioid overdose.
Westfall explained to AAFP News that the HOMER trial originated from a prior study, “Implementing Technology and Medication-Assisted Treatment and Team Training in Rural Colorado,” which was aimed at increasing the use of MAT for OUD among rural practices in the state.
“We heard from many patients, physicians and practices questions about what is the best way to start a patient on treatment,” said Westfall. “The start of treatment for OUD is called induction and, while there are several evidence-based methods, there has not been a comparative effectiveness trial to determine the best method. Even more important may be identifying which patient is most likely to benefit from which induction method.”
Practices selected for participation in the HOMER trial will be asked to identify six to 20 patients who have opioid dependence or OUD and who have opted to receive MAT with buprenorphine.
Identified patients will then be randomized to receive MAT in one of three methods:
Induction, Westfall said, “is a crucial first step to long-term treatment. One must successfully complete MAT induction to move on to MAT stabilization and, ultimately, MAT maintenance.”
Westfall said that research to determine the best method of MAT induction is lacking, as is research that indicates which patients would derive the most benefit from each method.
As such, the HOMER study’s aims are to
Practices selected for participation will undergo training beginning in March 2021. During the trial, participating practices will have access to a variety of MAT resources, including treatment forms, protocols and guidelines.
Patient enrollment will occur for 12 months beginning in April 2021. Patients who participate in the trial will be monitored and their data tracked for nine months. During this time they will be asked to complete a series of surveys related to quality of life, self-reported opioid use and other measures. Clinic staff and prescribing physicians may also be asked to complete surveys or participate in interviews.
Overall, the trial will run for three years and is expected to enroll 1,200 to 1,400 patients to allow for attrition.
One hundred primary care practices throughout the United States are expected to be involved in the trial. Although the recruitment period runs through February 2021, FPs who want to participate are highly encouraged to submit a study interest form at their earliest convenience.
Westfall explained how FPs individually, and the specialty in general, could benefit from taking part in the study.
“Family doctors are on the front lines of the opioid epidemic,” Westfall said. “We see lots of patients with opioid use disorder, and many want to get help. Too often, the big universities do these studies on a very narrow spectrum of patients and just expect family doctors to use that evidence, but evidence created at the academic medical center may not actually be the best evidence for a primary care practice.”
Family physicians who want to know more about the study can contact the AAFP NRN directly for more information.