Post-authorisation safety study (PASS) to evaluate risk minimisation measures for medication errors with Uptravi during the titration phase in patients with pulmonary arterial hypertension (PAH) in clinical practice (EDUCATE)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  UPTRAVI
• Study drug International non-proprietary name (INN) or common name:
  SELEXIPAG
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AC27) selexipag

  selexipag
• Medical condition to be studied:
  Pulmonary arterial hypertension

Population studied

• 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:
  260

Study design details

• Main study objective:
  The objectives of this study are to describe HCPs’ and patients’ awareness (process), knowledge (impact), and comprehension (impact) of the RMM (risk minimisation measures) and to record the occurrence of patient-reported “wrong dose” medication errors (outcome) at completion of titration or discontinuation of Uptravi during titration.
• Outcomes:
  Outcome is defined per ARMM (Additional risk minimization measures) effectiveness indicators: process, impact and outcome (i.e. patient-reported medication errors). Process refers to indicators to determine the dissemination of the ARMM and any instructions received from the HCP regarding the titration process. Impact involves questions to measure knowledge, comprehension, actions, and behavior associated with the use of Uptravi.
• Data analysis plan:
  Data analyses will be descriptive in nature and will focus on summarising the questionnaire responses from HCPs and patients, information on characteristics of the respondents, and medical chart–recorded PAH characteristics. Summary tables consisting of frequencies with percentages and 95% CIs for the proportion of correct responses will be created for all questionnaires. Results will be analysed and presented by country and by relevant variables, if the study size permits.