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

Evaluation of the Effectiveness of the Belatacept (Nulojix®) Patient Alert Cards in Patients Following Renal Transplantation in European Economic Area Countries

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.

Study Overview

• Status: Completed
• Conditions: Renal Transplant

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, A-4020
    • Local Institution
  • Vienna, Austria, A-1090
    • Local Institution
• France
  • Besançon, France, 25030
    • Local Institution
  • Brest, France, 29200
    • CHU Brest Hopital la Cavale Blanche
  • Burdeux, France, 33000
    • CHU Bordeaux Hôpital Pellegrin
  • Clermont-Ferrand, France, 63000
    • CHU Clemont Ferrand
  • Créteil, France, 94000
    • APHP Hôpital Henri Mondor
  • Le Kremlin-Bicêtre, France, 94270
    • Local Institution
  • Toulouse, France, 31059
    • CHU Toulouse Hopital Rangueli
  • Tours, France, 37000
    • Chu Tours Hopital Bretonneau
• Germany
  • Dresden, Germany, 1307
    • Local Institution
  • Kiel, Germany, 24105
    • Local Institution
  • Mannheim, Germany, 68167
    • UK Mannheim
• Sweden
  • Uppsala, Sweden, 75185
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort 1: Patient enrolled by physicians based in hospital and physician renal units

Cohort 2: Physicians and nurses based in hospital and physician renal units

Cohort 3: Patient enrolled by physicians based in hospital and physician renal units

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Patients survey; Adult patients treated with belatacept for renal transplantation
HCP survey; HCP with at least 1 patient taking belatacept
Retrospective chart review study; Adult patients treated with belatacept for renal transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient survey: Mean scores for correct responses for questions grouped by objectives	Objectives: distribution, awareness, utility, utilization and knowledge	At patient enrolment
HCP survey: Mean total score for correct responses		Day 1
HCP survey: Mean scores for correct responses for questions grouped by objectives	Objectives: distribution, awareness, utility, utilization and knowledge	Day 1
Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC		At patient enrolment
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: Proportion of patients with correct responses to behavioral questions		At patient enrolment
HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC		Day 1
HCP survey: Proportion of HCPs who have utilised the PAC, and the extent of its use		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	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	Day 1
HCP survey: Behavior of HCPs based on responses to behavioral questions		Day 1
Retrospective chart review study (clinical outcome study): Proportion of serious infections		Upto 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Day 1
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 from symptom onset of infection to receipt of medical therapy		Upto 4 years
Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria		Upto 4 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2016
• Primary Completion (Actual): May 19, 2017
• Study Completion (Actual): May 19, 2017

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IM103-367