NCT07221890

A Trial of Academic Detailing to Promote Prescribing of Biosimilars

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,325 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Autoimmune Diseases
• Rheumatoid Arthritis (RA)
• Inflammatory Bowel Disease (IBD)
• Psoriasis (PsO)

Interventions

Type	Name	Description
OTHER	Offered an academic detailing session	Clinicians will be offered an academic detailing session that will be delivered by a specially trained pharmacist, nurse, or physician (i.e., detailer). These academic detailers will be provided and trained by an independent non-profit organization. After a clinician agrees to participate in an academic detailing session, the detailer will schedule a 1-on-1 meeting lasting 15-20 minutes during which the detailer will provide educational information about biosimilars tailored to their knowledge and attitudes on the topic. During the session, the clinician will be provided printed and/or digital materials, including an educational brochure and patient education materials. Clinicians will also receive access to a summary evidence document containing all of the material with citations. Clinicians will also be offered the opportunity to claim continuing medical education (CME) credits for participating.
OTHER	Standard-of-care outreach from the insurance plan	Clinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars.

Timeline

• Start date: 2025-11-06
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2025-10-28
• Last updated: 2025-12-08

Locations

2 sites across 1 country: United States