Impact of Specialised Renal Care in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomised trial studying patients with stage 3 to 5 chronic kidney disease (CKD) in order to determine the impact of specialised care by nephrologists compared to guidelines-directed management by primary care physicians (PCP) on: a) prognosis (clinical outcome), b) planning of renal replacement therapy (RRT) (urgent versus planned initiation RRT) and c) patient satisfaction.

Official Title
-----------------
Impact of Specialised Renal Care in Patients With Chronic Kidney Disease Stage 3-5: A Prospective Randomised Study. The Implicate Study

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Behavioral: specialised renal care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CKD stage 3, 4 and 5 (CCl < 40 ml/min according to abbreviated MDRD formula) aged 18-80 years old and enrolled during a hospitalization. Exclusion Criteria: Patients previously known by nephrologists. Estimated life expectancy < 1 year Refusal or inability to sign writing consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nephrologists<br>Combined management PCP: nephrologists (at least 4 nephrology visits/year) | Behavioral: specialised renal care<br>* Combined management PCP - nephrologists (at least 4 nephrology visits/year). Agreement of the PCP is required for this combined management. Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG. Requested Email or over the phone advices to PCPs will be provided by the nephrology division of HUG.<br>|
| Active Comparator: Primary Care Physicians<br>Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG | Behavioral: specialised renal care<br>* Combined management PCP - nephrologists (at least 4 nephrology visits/year). Agreement of the PCP is required for this combined management. Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG. Requested Email or over the phone advices to PCPs will be provided by the nephrology division of HUG.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary (composite): death, and hospitalisation | death and emergency hospitalisation during the following 2 years afterr andomisation | 24 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life | cf title | 24 months after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney disease, Nephrologists, Primary Care, Death, Renal Replacement Therapy, Specialised renal care