A Trial of Academic Detailing to Promote Prescribing of Biosimilars

NCT07221890 | Active Not Recruiting

• 1 other identifier: 2025P002143
• Study Type: interventional
• Target: 1,325
• Locations: 1 country
• Sites: 2

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. 1.Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab?
2. 2.Do in-person or virtual visits work better?

Conditions

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

Keywords

biosimilar; biologic; academic detailing; clinician education; prescribing; Medicare Part D

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

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

Control

ACTIVE COMPARATOR

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

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

Interventions

Offered an academic detailing session OTHER

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.

Intervention

Standard-of-care outreach from the insurance plan OTHER

Clinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars.

Control; Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Humana Healthcare Research, Inc.: collaborator

Study Sites (2)

Humana Healthcare Research, Inc.

Louisville, Kentucky, 40202, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Autoimmune Diseases; Arthritis, Rheumatoid; Inflammatory Bowel Diseases; Psoriasis

Condition Hierarchy (Ancestors)

Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Skin Diseases, Papulosquamous; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 28, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (2)