Evaluation of the Effectiveness of the Abatacept (Orencia®) IV and SC Patient Alert Cards in Patients With Rheumatoid Arthritis in European Economic Area Countries
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 203
- Locations
- 25
- Primary Endpoint
- HCP survey: Mean total score for correct responses
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of the study is to determine a) if the implementation of abatacept (Orencia®) patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.
Detailed Description
3 sub studies: 2 Cross-Sectional and 1 retrospective chart review
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient survey (cohort 1):
- •Patients has taken abatacept within the previous 3 months for rheumatoid arthritis
- •Patient is 18 years of age or over
- •HCP survey (cohort 2):
- •a) Physician or nurses working in rheumatology centers, with at least 1 patient taking abatacept in the previous 6 months for rheumatoid arthritis (by prescribing, administering or by follow up)
- •Retrospective chart review study (cohort 3):
- •Patient survey questionnaire completed , Informed Consent Form (ICF) signed
Exclusion Criteria
- •Patient survey:
- •Patient has participated in a clinical trial for their arthritis in the previous 12 months
- •Currently an employee of BMS
- •HCP survey:
- •Physicians or nurse who have recruited patients for the Patient survey
- •Currently an employee of BMS
Outcomes
Primary Outcomes
HCP survey: Mean total score for correct responses
Time Frame: Day 1
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment
Time Frame: At patient enrolment
Patient survey: Proportion of patients treated with abatacept who have received the PAC
Time Frame: At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment
Time Frame: At patient enrolment
Patient survey: Mean total score for correct responses
Time Frame: At patient enrolment
Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use
Time Frame: At patient enrolment
Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC
Time Frame: At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives
Time Frame: At patient enrolment
Objectives: distribution, awareness, utility, utilization and knowledge
HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC
Time Frame: Day 1
HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use
Time Frame: Day 1
HCP survey: Levels of HCPs' knowledge and comprehension related to the important identified risks of infections and the need to screen for specific infection prior to initiating or administering abatacept
Time Frame: Day 1
Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization
Time Frame: Approximately 3 months
HCP survey: Mean scores for correct responses for questions grouped by objectives
Time Frame: Day 1
Objectives: distribution, awareness, utility, utilization and knowledge
Secondary Outcomes
- Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients(At patient enrolment)
- Determinants of Health Care Professional (HCP) understanding, Implementation regarding key messages contained in the PAC based on data collected in the abatacept IV and SC formulation PACs among HCPs(Day 1)
- Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients(At patient enrolment)
- Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients(At patient enrolment)
- Retrospective chart review study (clinical outcome study): Proportion of patients with results of any test to screen for Tuberculosis (TB) prior to administration of therapy of abatacept(Upto 8 years)
- Retrospective chart review study (clinical outcome study): Proportion of patients with results of any test to screen for viral hepatitis before administration of therapy with abatacept(Upto 8 years)
- Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention(Upto 8 years)