A Trial of Academic Detailing to Promote Prescribing of Biosimilars
- Conditions
- Autoimmune DiseasesRheumatoid Arthritis (RA)Inflammatory Bowel Disease (IBD)Psoriasis (PsO)
- Registration Number
- NCT07221890
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
The goal of this trial is to learn if an interactive evidence-based educational outreach visits to clinicians who prescribe biologics change prescribing of biosimilar medications. The main questions it aims to answer are:
1. Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab?
2. Do in-person or virtual visits work better?
Researchers will compare clinicians offered the educational outreach visit to those who are not offered the visit to see if there is a difference in prescribing of biosimilar versions of adalimumab instead of the original brand-name version.
Participants will be offered the chance to meet with a trained clinician who will provide educational information tailored to their knowledge and attitudes on the topic. They will also be provided an educational brochure and patient educational materials.
- Detailed Description
This is a parallel, cluster randomized controlled trial in which medical practices with clinicians who prescribed adalimumab (Humira) to patients in a Humana Medicare Prescription Drug Plan (PDP) will be randomized to have eligible clinicians within the practice invited to participate in the educational module about biosimilars (the intervention group). Practices with eligible physicians that are not offered the educational module will serve as the comparison group (the control group). The study will include practices in all 50 US states and Washington, DC, and practices will be stratified into approximately 50 geographic regions. Regions containing about half of the eligible clinicians will have the module offered to the intervention group in-person and the other half of regions will have the module offered virtually. Practices will be randomized 2:1 to be offered detailing (intervention) vs. not be offered detailing (control). Outcomes, including the use and cost of biologics and biosimilars, will be measured from routinely-collected prescribing data using the Humana Research Database.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1325
- Wrote 7 or more adalimumab prescriptions that were filled by patients enrolled in research-eligible Humana Medicare Part D plans in the calendar year 2025
- Retired
- Not able to identify active clinical practice in the US (50 states plus Washington DC)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of biosimilar adalimumab prescriptions per clinician 12 months Number of originator adalimumab (Humira) prescriptions per clinician 12 months Total spending (payer + patient) on adalimumab 12 months Patient out-of-pocket spending on adalimumab 12 months
- Secondary Outcome Measures
Name Time Method Number of participants in the intervention arm who participated in an educational meeting with an academic detailer 6 months Number of filled biosimilar prescriptions for other medications with biosimilar versions available, including ustekinumab, tocilizumab, and infliximab 12 months Number of filled prescriptions for other brand-name disease-modifying medications that are FDA approved to treat 1 or more of the same indications as adalimumab, such as TNF-alpha inhibitors and interleukin inhibitors 12 months Number of patients who fill 1 or more prescriptions for biosimilar adalimumab who subsequently switch back to originator biologic 12 months
Trial Locations
- Locations (2)
Humana Healthcare Research, Inc.
🇺🇸Louisville, Kentucky, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Humana Healthcare Research, Inc.🇺🇸Louisville, Kentucky, United States