A Trial of Academic Detailing to Promote Prescribing of Biosimilars

Mass General Brigham

Status: Active, not recruiting

Conditions: Rheumatoid Arthritis (RA); Inflammatory Bowel Disease (IBD); Psoriasis (PsO); Autoimmune Diseases

Treatments: Other: Standard-of-care outreach from the insurance plan; Other: Offered an academic detailing session

Study type: Interventional

Funder types: Other

Identifiers

NCT07221890

2025P002143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,325 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Retired
• Not able to identify active clinical practice in the US (50 states plus Washington DC)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,325 participants in 2 patient groups

Intervention

Experimental group

Description:

Offered an academic detailing session either in-person or virtually (depending on assigned geographic region), plus standard-of-care outreach from the insurance plan.

Treatment:

Other: Offered an academic detailing session

Other: Standard-of-care outreach from the insurance plan

Control

Active Comparator group

Description:

Not offered an academic detailing session. Standard-of-care outreach from the insurance plan.

Treatment:

Other: Standard-of-care outreach from the insurance plan