Protocol for the Effectiveness Check of the Awareness and Knowledge of Educational Materials for the Eligard Risk Minimization Program

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L02AE02) leuprorelin

  leuprorelin

Population studied

• Short description of the study population:
  Groups of health care professionals (HCPs) receiving Dear Healthcare Provider Communication (DHPC) who typically reconstitute and/or administer and/or dispense Eligard®/Depo-Eligard® to patients or healthcare professionals.
• 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:
  0

Study design details

• Main study objective:
  1) To measure the awareness of and participation in the Eligard®/Depo-Eligard® RM activities addressing the potential risk of lack of clinical efficacy due to incorrect reconstitution of the product2) To measure HCP knowledge of a potential risk of lack of efficacy due to incorrect reconstitution process of Eligard®/Depo-Eligard®.
• Data analysis plan:
  Process Indicators -- Percentage of respondents that recall: receiving the DHPC, reading the DHPC. Percentage of respondents that recall: receiving additional educational materials, reading or viewing additional educational materials, awareness of additional RM activities, participating in additional RM activities. Outcome Indicators -- Overall knowledge level of each target group, calculated as the mean of individual knowledge scores in that group, The percentage of correct responses for each knowledge question for each target group.