Improved Accessibility to the Renal Transplant List (2ALTR)

ARS Experimentation Project: Improving Accessibility to the Renal Transplantation List

In 2014, the "States General of Kidney" have allowed to assess the situation concerning the management of chronic kidney disease on the national territory. Ex-Languedoc-Roussillon has emerged as one of the French regions with a high dialysis / transplant ratio compared to other regions. Disparities in accessibility to the kidney transplant list were also very important. In the ex-Languedoc-Roussillon Region, the number of patients on the renal transplant list was lower than the national average (18.9 vs. 24.1%, respectively, according to the REIN 2015 report).

In 2015, the Regional Health Agency (ARS) ex-Languedoc-Roussillon, has published proposals to improve the healthcare of the patient in chronic end stage renal failure, and accessibility to the national waiting list for renal transplantation (CRISTAL).

To increase accessibility to the national waiting list for renal transplantation by improving the patient's healthcare, our project is based on the creation of a reinforced exchanges connexion between the hospital's nephrology services professionals, dialysis units and liberal nephrologists. This will include having regular meetings between dialysis nephrologists and CHU nephrologists. The proposals for this project were:

1. to organize multidisciplinary consultation meetings between transplant and dialysis professionals
2. to set up an exchange platform and communication tools built on the model of telemedicine (COVOTEM), common to the nephrology departments of the University Hospital Center, dialysis units.

This new device for the management of chronic end stage renal failure should increase the number of patients on the national renal transplantation waiting list. It should also make it possible to reduce the time between: firstly, the sending of the pre-registration file to the transplantation at Montpellier University Hospital and registration, and secondly between dialysis and registration.on waiting list.

The investigators hope that this experiment will increase the number of registrations on the National Kidney Transplantation Waitlist (CRISTAL). The implementation of this innovative tool should facilitate communication between nephrologists dialysis centers and nephrologists of CHU Montpellier, and accelerate the process of registration on the National Kidney Transplantation Waitlist.

If this platform proves to be easy to use and if the project's evaluation criteria show significant results, the platform could then be used to monitor patients in post-transplantation. Indeed, the data of patients who perform an alternating follow-up would be available for the referring nephrologists and for the transplant center. The further development of the platform would allow to create a mode of communication via this platform.

Study Overview

• Status: Unknown
• Conditions: Chronic End Stage Renal Failure

Detailed Description

Main Objective: Evolution of the number of patients, dialysed or not dialysed in the ex-Languedoc-Roussillon Region, acceding during the year, to a pre-transplant assessment for a registration on the national renal transplantation waiting list ( CRISTAL).

Secondary Objectives:

• Evolution of patient waiting times for registration on the national renal transplantation waiting list (CRISTAL)
• For incident cases: Evolution of the time between dialysis, and the date of registration on the transplant waiting list or the date of decision of temporary or definitive contraindication by nephrologists CHU Montpellier .
• Evolution of the delays between the date of reception of the pre-registration file by the nephrology department of the University Hospital and the closing date of the file (either a definitive inscription, a definitive contraindication or a temporary contraindication > 4 months)
• Evolution of the number of multidisciplinary consultation meetings performed without videoconferencing and videoconferencing between the dialysis center and Montpellier University Hospital
• Evaluation of exchanges between professionals involved in the course of care of the patient in chronic end stage renal failure

• Study Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • UH Montpellier
    • Contact: Coralie CHAMPION, ARC; Phone Number: 33 04 67 33 03 64; Email: c-champion@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients dialysed or not dialysed with end stage renal failure, eligible for a pre-transplant assessment

Description

Inclusion Criteria:

• Dialysis or non-dialysis patients with chronic renal insufficiency with a GFR < 20ml / min eligible for transplant
• Patient wishing to start the registration process at the transplant
• Patient giving consent for the transmission of his data via an electronic platform

Exclusion Criteria:

• Patient already enrolled
• Patient having a pathology with a life expectancy of less than two years
• Patient with serious psychiatric disorders , or dementia.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient dialysed or not dialysed acceding to a pre-transplant assessment for a registration on the national renal transplantation waiting list ( CRISTAL).	Number of patient dialysed or not dialysed acceding to a pre-transplant assessment for a registration on the national renal transplantation waiting list ( CRISTAL).	1 year, up to the end of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of files received by the nephrology department of Montpellier University Hospital on the COVOTEM platform	Number of files received by the nephrology department of Montpellier University Hospital on the COVOTEM platform	1 year, up to the end of study
Number of dialysis patients who had a pre-transplant evaluation	Number of dialysis patients who had a pre-transplant evaluation	1 year, up to the end of study
Number of non-dialysis patients who had a pre-transplant evaluation	Number of non-dialysis patients who had a pre-transplant evaluation	1 year, up to the end of study
Number of patients on temporary or definitive contraindications	Number of patients on temporary or definitive contraindications	1 year, up to the end of study
Average period between the dialysis of the patient and the reception of the pre-registration file by the nephrology department of Montpellier University Hospital	Average period between the dialysis of the patient and the reception of the pre-registration file by the nephrology department of Montpellier University Hospital	1 year, up to the end of study
Average period between the reception of the pre-registration file by the nephrology department of the University Hospital of Montpellier and the consultation appointment for registration	Average period between the reception of the pre-registration file by the nephrology department of the University Hospital of Montpellier and the consultation appointment for registration	1 year, up to the end of study
Average period between the reception of the pre-registration file	Average period between the reception of the pre-registration file by the nephrology department of the CHU of Montpellier and the closing of the file (either a definitive inscription, a definitive contraindication, or a temporary contraindication > 4months)	1 year, up to the end of study
Rate of participation of the centers in the experimentation (Number of files received by the nephrology department of the University Hospital Center of Montpellier per center)	Rate of participation of the centers in the experimentation (Number of files received by the nephrology department of the University Hospital Center of Montpellier per center)	1 year, up to the end of study
Number of multidisciplinary consultation meetings performed without videoconferencing or videoconferencing between the dialysis center and Montpellier University Hospital Center	Number of multidisciplinary consultation meetings performed without videoconferencing or videoconferencing between the dialysis center and Montpellier University Hospital Center	1 year, up to the end of study
Average period between the consultation appointment and the closing of the file (either a definitive inscription, a definitive contraindication, or a temporary contraindication > 4months	Average period between the consultation appointment and the closing of the file (either a definitive inscription, a definitive contraindication, or a temporary contraindication > 4months	1 year, up to the end of study
Number of non-dialysis patients with renal insufficiency enrolled preemptively on the national renal transplantation waiting list	Number of non-dialysis patients with renal insufficiency enrolled preemptively on the national renal transplantation waiting list	1 year, up to the end of study

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Aider Montpellier : Dr Chalabi Lofti; Aider Cèvennes et Confins Rhodaniens : Dr Mohajer Médérick; Aider Nîmes : Philippe LAN YUE WAH; Aider Lozère : Dr Hélène LERAY / Dr Cécile TURC-BARON; Aider Perpignan : Dr Ahmed RACHI; CHU de Nîmes : Pr Moranne Olivier; CH de Perpignan : Dr Vela Carlos; Centre d'Hémodialyse St Guilhem : Dr Argilès Angèl; Clinique Médipôle Perpignan : Dr DECOURT Alexandre; Clinique de Narbonne : Dr De Cornélissen François; GCS Help : Dr Maria Eugenia Noguera Gonzales; NephroCare Castelnau / Mas du Rochet / Lunel : Dr Basel Olivia; NephroCare Béziers : Dr Baron Emmanuel; NephroCare Nîmes / Bagnols : Dr Rousseau Philippe; Villeneuve les Béziers : Dr Baron Emmanuel; GCS eSanté : Sylvain Collet
• Investigators: Principal Investigator: Sylvie DELMAS, Doctor, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ANTICIPATED): November 30, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (ACTUAL): May 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Kidney transplant; Nephrology; Registration; Transplant waiting list
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: RECHMPL19_0138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No