The Home versus Office for Medication Enhanced Recovery (HOMER) study, a pragmatic comparative-effectiveness research trial, has successfully navigated significant challenges posed by the COVID-19 pandemic and evolving trends in opioid use disorder (OUD) treatment. The study, initially designed to compare the effectiveness of home versus office-based buprenorphine induction for OUD, has adapted its methodology to incorporate telehealth inductions and address patient preferences, ensuring continued progress in this critical area of research.
Adapting to the COVID-19 Pandemic
The COVID-19 pandemic presented numerous obstacles to the HOMER study, including the rapid shift to telehealth visits and the overwhelming demands on primary care practices. Originally conceived as a randomized trial comparing home and office-based buprenorphine induction, the study team recognized the need to adapt to the changing landscape of healthcare delivery. To address this challenge, a third study arm was added to evaluate telehealth induction, allowing patients to initiate buprenorphine treatment remotely under observation. This modification required significant changes to the study design and statistical analysis plan, but ultimately enabled the study to continue enrolling participants during the pandemic.
Addressing Patient Preferences
Another significant challenge encountered by the HOMER study was the reluctance of some patients to undergo randomization. Many patients expressed a strong preference for a particular induction method, leading to a decline in enrollment. To address this issue, the study team transitioned to a comprehensive cohort design, allowing patients to choose their preferred induction method while still collecting valuable data on treatment outcomes. This change not only increased participation but also opened up new research questions, including investigating differences between randomized and nonrandomized participants.
Evolving Treatment Landscape
The HOMER study also addressed the evolving landscape of OUD treatment, including the increasing use of low-dose buprenorphine and the rise of mixed drug use. Low-dose buprenorphine, also known as "microdosing," has emerged as a strategy to mitigate withdrawal symptoms during induction, particularly in patients using fentanyl. The study team clarified that low-dose buprenorphine is simply a specific dosing regimen and included patients using this approach in the study. Additionally, the study addressed the challenges of mixed drug use, providing educational webinars on the identification and treatment of newer drugs.
Lessons Learned
Despite the challenges encountered, the HOMER study has made significant progress in advancing OUD treatment research. As of January 2024, the study had enrolled nearly 300 participants, and data collection is ongoing. The study team has learned valuable lessons about conducting research during a pandemic, including the importance of flexibility, adaptability, and community engagement. The HOMER study serves as a model for other researchers seeking to address critical healthcare challenges in a rapidly changing world. According to the authors, "The COVID-19 pandemic, the changes in OUD, and the emergence of fentanyl analogues challenged the team and investigators. Keeping the destination clear in our minds helped us navigate through the troubles."
ClinicalTrials.gov Identifier
NCT04664062
