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

Renal Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581644
• Other study ID #: IM103-367
• Status: Completed
• Phase: N/A
• First received: September 28, 2015
• Last updated: June 14, 2017
• Start date: November 29, 2016
• Est. completion date: May 19, 2017

Study information

• Verified date: June 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 19, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplant

Locations

Country	Name	City	State
Austria	Local Institution	Linz
Austria	Local Institution	Vienna
France	Local Institution	Besançon
France	CHU Brest Hopital La Cavale Blanche	Brest
France	CHU Bordeaux Hopital Pellegrin	Burdeux
France	CHU Clemont Ferrand	Clermont-Ferrand
France	APHP Hopital Henri Mondor	Créteil
France	Local Institution	Le Kremlin-Bicêtre
France	CHU Toulouse Hopital Rangueli	Toulouse
France	CHU Tours Hopital Bretonneau	Tours
Germany	Local Institution	Dresden
Germany	Local Institution	Kiel
Germany	UK Mannheim	Mannheim
Sweden	Local Institution	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Austria,  France,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC		At patient enrolment
Primary	Patient survey : Proportion of patients treated with belatacept who have received the PAC		At patient enrolment
Primary	Patient survey : Proportion of patients who have utilised the PAC, and the extent of its use		At patient enrolment
Primary	Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of belatacept treatment		At patient enrolment
Primary	Patient survey: HCP-patient communication based on responses to specific questions		At patient enrolment
Primary	Patient survey: Proportion of patients with correct responses to behavioral questions		At patient enrolment
Primary	Patient survey: Mean scores for correct responses for questions grouped by objectives	Objectives: distribution, awareness, utility, utilization and knowledge	At patient enrolment
Primary	HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC		Day 1
Primary	HCP survey: Proportion of HCPs who have utilised the PAC, and the extent of its use		Day 1
Primary	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
Primary	HCP survey: Behavior of HCPs based on responses to behavioral questions		Day 1
Primary	HCP survey: Mean total score for correct responses		Day 1
Primary	HCP survey: Mean scores for correct responses for questions grouped by objectives	Objectives: distribution, awareness, utility, utilization and knowledge	Day 1
Primary	Retrospective chart review study (clinical outcome study): Proportion of serious infections		Upto 4 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Retrospective chart review study (clinical outcome study) : proportion of infections leading to discontinuation		Upto 4 years
Secondary	Retrospective chart review study (clinical outcome study) : mean time from symptom onset of infection to receipt of medical therapy		Upto 4 years
Secondary	Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria		Upto 4 years

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