A Cross-sectional Study Among Healthcare Professionals in Canada to Assess Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures

Study type

• Study topic:
  Other
• Study topic, other:
  Assessment of awareness and knowledge of the fibristal additional risk minimization measures
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  aRMM evaluation (Safety)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  A Cross-sectional Study Among Healthcare Professionals

Population studied

• Short description of the study population:
  HCPs in Canada who prescribe Fibristal. The target population is the list of HCPs who were mailed the Fibristal aRMMs in the 1st quarter of 2019
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the aRMMs for Fibristal among HCPs who prescribe Fibristal in Canada.
• Outcomes:
  Assess levels of HCPs’ knowledge for the following: -The updated indication (restrict intermittent treatment to those women who are not eligible for surgery) and contraindication (Fibristal must not be used in women with history of/or active hepatic disease). -New requirements for liver function test monitoring. -Patient counseling. -Assess levels of receipt and reading of the Fibristal HCP Letter and Fibristal HCP Brochure, distribution of the Patient Alert Card, and counseling patients on the information in the Patient Alert Card, among HCPs who prescribe Fibristal. -Assess the primary source(s) from which HCPs learned about the core messages included in the Fibristal aRMMs. -Interpret composite variable on level of HCP
• Data analysis plan:
  Survey results will be analyzed using SAS, most of the analyses are planned to be descriptive in nature. Results will be summarized in tables. Frequencies, percentages, and corresponding 95% confidence intervals (CIs) will be used to summarize the primary and secondary endpoints. For each knowledge-level question, the percentage of HCPs who answer each question correctly will be calculated and assessed against an 80% (± 95% CI) target threshold for success.