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

Completed

• Conditions: Renal Transplant

• Registration Number: NCT02581644
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Study Start: 2016-11-29
• Primary Completion: 2017-05-19
• Study Completion: 2017-05-19
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HCP survey: Behavior of HCPs based on responses to behavioral questions	Day 1
HCP survey: Proportion of HCPs who have utilised the PAC, and the extent of its use	Day 1
Patient survey: Proportion of patients with correct responses to behavioral questions	At patient enrolment
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	Day 1	The percentage of HCPs with responses to each question in the HCP questionnaire that would indicate effectiveness of the PAC will be determined: who are aware of the PAC, use the PAC, level of knowledge and comprehension of the risks and mean scores for correct responses
HCP survey: Mean total score for correct responses	Day 1
Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC	At patient enrolment
HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC	Day 1
Retrospective chart review study (clinical outcome study): Proportion of serious infections	Upto 4 years
Patient survey : Proportion of patients treated with belatacept who have received the PAC	At patient enrolment
Patient survey : Proportion of patients who have utilised the PAC, and the extent of its use	At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of belatacept treatment	At patient enrolment
Patient survey: HCP-patient communication based on responses to specific questions	At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives	At patient enrolment	Objectives: distribution, awareness, utility, utilization and knowledge
HCP survey: Mean scores for correct responses for questions grouped by objectives	Day 1	Objectives: distribution, awareness, utility, utilization and knowledge

Secondary Outcome Measures

Name	Time	Method
Major determinants of patients knowledge of the key messages contained in the belatacept PAC based on data collected in the patient questionnaire	At patient enrolment	Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept
Retrospective chart review study (clinical outcome study) : mean time from symptom onset of infection to receipt of medical therapy	Upto 4 years
Major determinants of understanding the key messages contained in the PAC based on data collected in the patient questionnaire	At patient enrolment	Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept
Retrospective chart review study (clinical outcome study) : proportion of infections leading to discontinuation	Upto 4 years
Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria	Upto 4 years
Determinants of Health Care Professional (HCP) understanding and implementation regarding key messages contained in the PAC based on data collected in the patient questionnaire	Day 1	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
Major determinants of implementation regarding the key messages contained in the PAC based on data collected in the patient questionnaire	At patient enrolment	Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept

Trial Locations

Locations (8)

CHU Clemont Ferrand; 🇫🇷 Clermont-Ferrand, France

APHP Hopital Henri Mondor; 🇫🇷 Créteil, France

Local Institution; 🇸🇪 Uppsala, Sweden

CHU Bordeaux Hopital Pellegrin; 🇫🇷 Burdeux, France

CHU Brest Hopital La Cavale Blanche; 🇫🇷 Brest, France

CHU Tours Hopital Bretonneau; 🇫🇷 Tours, France

CHU Toulouse Hopital Rangueli; 🇫🇷 Toulouse, France

UK Mannheim; 🇩🇪 Mannheim, Germany