Clinical trial NCT03934554: Improved Accessibility to the Renal Transplant List
Official title: ARS Experimentation Project: Improving Accessibility to the Renal Transplantation List
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic End Stage Renal Failure
Keywords: Nephrology
Kidney transplant
Registration
Transplant waiting list
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Aider Montpellier : Dr Chalabi Lofti
name: Aider Cèvennes et Confins Rhodaniens : Dr Mohajer Médérick
name: Aider Nîmes : Philippe LAN YUE WAH
name: Aider Lozère : Dr Hélène LERAY / Dr Cécile TURC-BARON
name: Aider Perpignan : Dr Ahmed RACHI
name: CHU de Nîmes : Pr Moranne Olivier
name: CH de Perpignan : Dr Vela Carlos
name: Centre d'Hémodialyse St Guilhem : Dr Argilès Angèl
name: Clinique Médipôle Perpignan : Dr DECOURT Alexandre
name: Clinique de Narbonne : Dr De Cornélissen François
name: GCS Help : Dr Maria Eugenia Noguera Gonzales
name: NephroCare Castelnau / Mas du Rochet / Lunel : Dr Basel Olivia
name: NephroCare Béziers : Dr Baron Emmanuel
name: NephroCare Nîmes / Bagnols : Dr Rousseau Philippe
name: Villeneuve les Béziers : Dr Baron Emmanuel
name: GCS eSanté : Sylvain Collet
First posted: 2019-05-02
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients dialysed or not dialysed with end stage renal failure, eligible for a pre-transplant assessment

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patient dialysed or not dialysed acceding to a pre-transplant assessment for a registration on the national renal transplantation waiting list ( CRISTAL).
timeFrame: 1 year, up to the end of study
Secondary outcomes:
measure: Number of files received by the nephrology department of Montpellier University Hospital on the COVOTEM platform
timeFrame: 1 year, up to the end of study
measure: Number of dialysis patients who had a pre-transplant evaluation
timeFrame: 1 year, up to the end of study
measure: Number of non-dialysis patients who had a pre-transplant evaluation
timeFrame: 1 year, up to the end of study
measure: Number of patients on temporary or definitive contraindications
timeFrame: 1 year, up to the end of study
measure: Average period between the dialysis of the patient and the reception of the pre-registration file by the nephrology department of Montpellier University Hospital
timeFrame: 1 year, up to the end of study
measure: 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
timeFrame: 1 year, up to the end of study
measure: Average period between the reception of the pre-registration file
timeFrame: 1 year, up to the end of study
measure: 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)
timeFrame: 1 year, up to the end of study
measure: Number of multidisciplinary consultation meetings performed without videoconferencing or videoconferencing between the dialysis center and Montpellier University Hospital Center
timeFrame: 1 year, up to the end of study
measure: Average period between the consultation appointment and the closing of the file (either a definitive inscription, a definitive contraindication, or a temporary contraindication > 4months
timeFrame: 1 year, up to the end of study
measure: Number of non-dialysis patients with renal insufficiency enrolled preemptively on the national renal transplantation waiting list
timeFrame: 1 year, up to the end of study
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Sylvie DELMAS, Doctor
role: PRINCIPAL_INVESTIGATOR
References: