Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries

Bristol-Myers Squibb63 enrolled

Overview

The purpose of the study is to determine a) if the implementation of belatacept 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.

3 sub studies: 2 Cross-Sectional and 1 retrospective chart review

Study Type

OBSERVATIONAL

Enrollment

Conditions

Renal Transplant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient survey (cohort 1): * Patients has taken belatacept within the previous 3 months for renal transplantation * Patient is over 18 years of age * HCP survey (cohort 2): * Physician or nurses working in nephrology centers, with at least 1 patient taking belatacept in the previous 6 months for renal transplantation (by prescribing, administering or by follow up) * Retrospective chart review study (cohort 3): * Patient survey questionnaire received, Informed Consent Form (ICF) signed (if required) Exclusion Criteria: * Patient survey: * Patient has participated in a clinical trial for their renal condition 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

Locations (14)

Local Institution

Linz, Austria

Local Institution

Vienna, Austria

Local Institution

Besançon, France

Outcomes

Primary Outcomes

Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC

Time frame: At patient enrolment

Patient survey : Proportion of patients treated with belatacept who have received the PAC

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: Levels of patient knowledge and comprehension related to the important identified risks of belatacept treatment

Time frame: At patient enrolment

Patient survey: HCP-patient communication based on responses to specific questions

Time frame: At patient enrolment

Patient survey: Proportion of patients with correct responses to behavioral questions

Time frame: At patient enrolment

Patient survey: Mean scores for correct responses for questions grouped by objectives

Objectives: distribution, awareness, utility, utilization and knowledge

Time frame: At patient enrolment

HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC

Time frame: Day 1

HCP survey: Proportion of HCPs who have utilised 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 belatacept

Data from ClinicalTrials.gov

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Secondary Outcomes

Major determinants of patients knowledge of the key messages contained in the belatacept PAC based on data collected in the patient questionnaire

Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept

Time frame: At patient enrolment

Major determinants of understanding the key messages contained in the PAC based on data collected in the patient questionnaire

Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept

Time frame: At patient enrolment

Major determinants of implementation regarding the key messages contained in the PAC based on data collected in the patient questionnaire

Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept

Time frame: At patient enrolment

Determinants of Health Care Professional (HCP) understanding and implementation regarding key messages contained in the PAC based on data collected in the patient questionnaire

Determinants: type of HCP, country, age and gender of HCP years in specialty, number of HCPs in the unit, annual number of patients through the unit, number of patients for whom belatacept was prescribed in the previous 12 months, type of practice, type of institution (academic or non-academic), size of town

Time frame: Day 1

Retrospective chart review study (clinical outcome study) : proportion of infections leading to discontinuation

Time frame: Upto 4 years

Retrospective chart review study (clinical outcome study) : mean time from symptom onset of infection to receipt of medical therapy

Time frame: Upto 4 years

Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria

Time frame: Upto 4 years