A Cross-sectional Study Among Patients in Canada to Assess Awareness and Knowledge of the Fibristal Patient Alert Card

Study type

• Study topic:
  Other
• Study topic, other:
  Assessment of patients’ receipt and use of the Fibristal Patient Alert Card
• 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 non-interventional, cross-sectional survey study to evaluate effectiveness

Population studied

• Short description of the study population:
  Patients in Canada who have been treated with Fibristal. The target population will be derived primarily from patients treated by Healthcare Professionals who prescribe Fibristal.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  The overall objective of this study is to assess patients’ receipt and use of the Fibristal Patient Alert Card, and knowledge of the key messages included in Fibristal Patient Alert Card.
• Outcomes:
  Assess levels of patients’ knowledge for the following core message domains: - Potential for Fibristal to cause liver injury. - Signs and symptoms of liver problems. - What to do in case of signs and symptoms of liver problems. -Assess levels of receipt and use (e.g. read, carrying) of the Fibristal Patient Alert Card among patients who have received Fibristal. -Assess adherence of HCPs to counseling patients and to the requirement to order liver function tests, as reported by patients, in accordance with the recommendations in the aRMMs/CPM.
• 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 endpoints. For each knowledge level question, the percentage of patients who answer each question correctly will be estimated and assessed against a 70% (± 95% CI) target threshold for success.