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

• Medicinal product name:
  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

• Short description of the study population:
  To be eligible for the study, HCPs must meet all of the following criteria:; - Be included on the list of prescribing HCPs (physicians, pharmacists and nurses) via the country-specific Uptravi controlled access system or be a nurse in the practice with (and recruited by) these physicians.; - Treated or monitored at least one patient with Uptravi in the previous 12 months so they will be able to answer questions regarding their use of the ARMM and instructions to patients.; ; To be eligible for the study, patients must meet all the following criteria:; - ≥ 18 years old at enrolment; - Self-reported: Diagnosis of PAH by physician; - Provision of consent as part of the survey; - Agree to provide treating HCP’s contact information (refer to Section 9.6.2); - Be taking the survey ≤ 4 weeks after reaching individual maintenance dose of Uptravi or ≤ 4 weeks Uptravi discontinuation during titration.
• 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

• Study design:
  The study is an observational, cross-sectional survey of awareness, knowledge and self-reported behaviour
• 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.
• Setting:
  The study population will involve patients and HCPs from Europe, including centralised healthcare systems (ie, national PAH reference centres) and decentralised systems.
• Comparators:
  Limited data on nonparticipants
• 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.