Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust

Study Overview
=================
Brief Summary
-----------------
Kidney disease in its chronic or acute form shares many risk factors for initiation, progression and prognosis with an increase in morbidity and mortality, the length of hospitalization and the cost associated with stages of increasing severity. Its overall estimated prevalence in the general population is 13% and 0.5% from stage 4, for which referral to a nephrologist is recommended to reduce mortality, slow progression of renal disease and better prepare for treatment by renal replacement. Acute kidney injury (AKI) is defined as a sudden increase in serum creatinine (Scr) with a prognostic classification of increasing severity. The population with chronic kidney disease (CKD) is often hospitalized and is frequently complicated by AKI, however CKD is asymptomatic for a long time, requiring structure screening in populations at risk. Performing Scr assays during hospitalization is an opportunity to screen patients with severe CRD or ARI requiring specialized treatment during and after hospitalization. A nephrological opinion is recommended for patients with severe CKD and AKI. Based on preliminary studies MRC GARD (NCT02938611) and ARI TARGET (NCT03192189), the study investigators identified the frequency of patients with increased Scr corresponding to stages ≥4 of CKD and to stage1b of ARI during their hospitalization. They found that 50% of patients hospitalized with a severe AKI had a CKD prior to their hospitalization. The use of dosages of Scr during hospitalization has been studied for AKI but without targeting high-risk subgroups and with discordant results. The study investigators plan to carry out a pragmatic study to show that an intervention combining alerts with Scr dosage to detect severe forms of CRD and AKI during hospitalization associated with the systematic intervention of a specialized dedicated team associating nephrologist and pharmacist to the scale of a GHT will improve patient and renal survival 1 year after screening.

Official Title
-----------------
Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust

Conditions
-----------------
Acute Kidney Injury, Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Other: WARNING KD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient or their representative must have given their free and informed consent oral consent The patient must be a member or beneficiary of a health insurance plan Patient living in the Gard, France Patient with abnormal dose: Severe grade 4 or 5 CKD suspected in front of a GFR <30 mL / min / 1.73m2 persisting during hospitalization. Acute kidney injury > stage 1 defined by an increase in serum creatinine of at least 100% in less than 7 days or a threshold greater than 354 µmol / l. Exclusion Criteria: The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study It is impossible to give the subject or their representative informed information The patient is under safeguard of justice or state guardianship Patient is pregnant, parturient or breastfeeding. Patient unable to express consent Patient with Stage 1 Acute kidney injury defined by an increase in serum creatinine of more than 26 µmol / l in less than 48 hours or a 50% increase in serum creatinine within 7 days. Patient with stage 1 to 3 CKD (glomerular filtration rate (GFR)> 30 mL / min / 1.73m2) Palliative/end-of-life patients Patients who died within 72 hours of receiving the signal Patients hospitalized in nephrology after an emergency room visit only Patients under guardianship.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Cluster step wedge
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard strategy<br> | |
| Experimental: Warning KD strategy<br> | Other: WARNING KD<br>* Within 48h of detecting an abnormal creatinemia value (GFR<30 or AKIN2 and AKIN3), the biology laboratory will communicate the patient's information to the WARNING KD team. This team consists of one nephrologist and one clinical pharmacist who will trigger the initial management in the department and then, if the patient has a persistant warning signal during hospitalization, define the patient's course of treatment for discharge. Patients requiring special care will be oriented towards a nephrologist and the patient's GP will be alerted to the benefit of addressing the patient to a nephrologist for multidisciplinary management with a therapeutic project according to the recommendations for good therapeutic practices.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Information taken from national database | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for renal support | yes / no. Information available in the SNDS database and the REIN register. | 12 Months | 
| Mortality | Information taken from national database | 30 days | 
| Emergency start of renal support management | Yes/no with exact date noted if yes. Information available in the REIN register | 12 Months | 
| Oriented of patient towards autonomous support techniques | Yes/no. Information available in the REIN register | 12 Months | 
| Which autonomous support techniques used | renal transplant or home dialysis | 12 Months | 
| Use of an arteriovenous fistula during the first session | Yes/no | 12 Months | 
| Duration of initial hospitalization | Days | 12 Months | 
| Duration of rehospitalizations | Days | 12 Months | 
| Causes of rehospitalizations | Information taken from SNDS database | 12 Months | 
| The rate of patients with stage ≥4 CKD followed by a nephrologist | Data-collection via the medical file on visit(s) to the nephrologist during hospitalization; after discharge from hospital via data collected in the SNDS database | 12 Months | 
| Rate of patients with at least one inappropriate drug prescription for renal function |  | Inclusion | 
| Rate of patients with at least one inappropriate drug prescription for renal function |  | 3 Months | 
| Rate of patients with at least one inappropriate drug prescription for renal function |  | 12 Months | 
| Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications |  | Inclusion | 
| Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications |  | 3 Months | 
| Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications |  | 12 Months | 
| Estimation of the incremental cost-efficiency ratio | ratio of la difference in cost and the difference in life expectancy between the two strategies | 12 Months | 
| National scale estimation of costs avoided | Total costs of healthcare consumption and the cost of setting up the device in the two management strategies | 12 Months | 
| Evaluation of the satisfaction carers of patients in the interventional group during hospitalization | 6-item custom questionnaire on 5-point Likert scale with free comment section | end of the interventional strategy phase (minimum 3 months, maximum 12 months) | 
| Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization | 5-item custom questionnaire on 5-point Likert scale with free comment section | end of the interventional strategy phase (minimum 3 months, maximum 12 months) | 
| Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization | 5-item custom questionnaire on 5-point Likert scale with free comment section | 12 Months | 
| Evaluation of patient satisfaction of patients in the interventional group | 3-item custom questionnaire on 5-point Likert scale free comment section | end of the interventional strategy phase (minimum 3 months, maximum 12 months) | 
| Evaluation of patient satisfaction of patients in the interventional group | 3-item custom questionnaire on 5-point Likert scale free comment section | 12 months | 
| Evaluate the implementation of the WARNING KD management model at individual facilities according to the Template for Intervention Description and Replication (TIDieR) checklist. | 12-item checklist | Over the study - maximum 2 years |