HOMER is a national study comparing three methods of induction for Medication Assisted Treatment (MAT) for Opioid Use Disorder (OUD); home versus office versus telehealth-based inductions. This study will help determine if certain patient and practice characteristics make patients better candidates for one method over the others. Results will help fill a gap in the evidence around effectively treating OUD with MAT in primary care settings.
Office-based Opioid Treatment (OBOT) is the primary care or ambulatory care provision of medication assisted treatment (MAT) for patients suffering opioid use disorder (OUD). MAT with buprenorphine in primary care clinics is a proven strategy to treat opioid use disorder (OUD) and is slowly becoming accessible to patients through primary care. Treating patients with buprenorphine involves an initial induction, during which patients discontinue their opioids, begin withdrawal, and receive the first few doses of buprenorphine. National guidelines for OBOT have focused on observed, office-based induction to begin MAT. Over the years, unobserved, home MAT inductions have also been used and shown to be safe and effective. Individually, each induction strategy is evidence-based, guideline concordant care. In light of the current COVID-19 pandemic, inductions are also being conducted via telehealth using synchronous audio or video observation. Most research, on which the current guidelines are based, examined short-term outcomes. However, OUD is a chronic condition. MAT often involves intermittent return to illicit opioid use and treatment lapses, resulting in multiple attempts to remain in long-term treatment. Important differences between the activities that occur during home, office-based, and telehealth induction might influence short-term stabilization, long-term maintenance treatment, and quality of life outcomes. No large-scale, multi-center, randomized comparative effectiveness research has compared induction method on long-term outcomes for patients suffering from OUD seen in primary care settings.There is currently insufficient evidence to recommend home induction (asynchronous, unobserved), office induction (synchronous, observed), or telehealth induction (synchronous phone or video contact, observed). Acknowledging the dire need for increased access to effective treatment for OUD, patients and providers are eager to better understand if home, office-based, or telehealth induction in the primary care setting leads to more successful short-term stabilization and long-term maintenance treatment and patient outcomes. They also question whether certain patient characteristics, such as substance use history, executive function, and social determinants of health, are associated with better long-term outcomes in patients receiving one method versus the others. We propose a comparative effectiveness research study, randomized at the patient level, to compare short-term stabilization and long-term maintenance treatment outcomes of home induction (asynchronous, unobserved), office induction (synchronous, observed), or telehealth induction (synchronous phone or video contact, observed) for patients suffering from OUD and opioid dependence.
All subjects will undergo MAT induction with buprenorphine. Participants will be randomized to the behavioral aspects of induction, specifically comparing office induction vs home vs synchronous telehealth induction.
University of Colorado
Denver, Colorado, United States
American Academy of Family Physicians National Research Network
Leawood, Kansas, United States
Number of days patient took buprenorphine
Determined by prescription refills and patient self-report of number of days buprenorphine taken.
Time frame: 270 days
Number of days patient took illicit opioids
Determined by a patient self-report of the number of days they took other opioids and urine opioid test results.
Time frame: 270 days
Took buprenorphine on >80% of days
Determined by initial prescription and refills, a patient self-report of number of days buprenorphine taken, and urine buprenorphine results.
Time frame: 270 days
Percent (%) of patients that took other opioids on <10% of days
Determined by a patient self-report of the numer of days they took other opioids and urine opioid test results.
Time frame: 270 days
Social Determinant of Health and Quality of Life
Patient surveys completed per clinical care on quality of life (e.g., symptoms, side effects, depression), social connectedness, loneliness, and other select determinants of health.
Time frame: 270 days
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
303