A Trial of Academic Detailing to Promote Prescribing of Biosimilars
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,325
- 试验地点
- 4
- 主要终点
- Number of biosimilar adalimumab prescriptions per clinician
研究概览
简要总结
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:
- Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not able to identify active clinical practice in the US (50 states plus Washington DC)
研究组 & 干预措施
Intervention
Offered an academic detailing session either in-person or virtually (depending on assigned geographic region), plus standard-of-care outreach from the insurance plan.
干预措施: Offered an academic detailing session (Other)
Intervention
Offered an academic detailing session either in-person or virtually (depending on assigned geographic region), plus standard-of-care outreach from the insurance plan.
干预措施: Standard-of-care outreach from the insurance plan (Other)
Control
Not offered an academic detailing session. Standard-of-care outreach from the insurance plan.
干预措施: Standard-of-care outreach from the insurance plan (Other)
结局指标
主要结局
Number of biosimilar adalimumab prescriptions per clinician
时间窗: 12 months
Number of originator adalimumab (Humira) prescriptions per clinician
时间窗: 12 months
Total spending (payer + patient) on adalimumab
时间窗: 12 months
Patient out-of-pocket spending on adalimumab
时间窗: 12 months
次要结局
- 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)
- 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)
研究者
Benjamin Rome
Assistant Professor of Medicine
Brigham and Women's Hospital