The goal of this clinical study is to establish if the use of public health-related messages, designed and disseminated to a targeted population, will result in tangible improvements in patient outcomes and healthcare practices.
Specific health-related messages oriented towards patients, through their biological results and HealthCare Professionals (HCPs), will be sent to participants included in the intervention group. The control group will not receive any health-related message (routine care).
The aim is to evaluate if this intervention leads to differences in Major Adverse Renal and Cardiovascular Events (MARCE), compared to routine care (no dissemination of health messages) in patients suffering in diabetes and renal failure.
Subject attending a ML participating to the study
Subject presenting a HbA1c ≥ 6.5% and an estimated GFR (CKD-EPI formula) in the range 60 to 15 ml/min (included) and/or albumin to creatinine ratio ≥ 300 mg albumin/g creatinine (or 30 mg/mmol creatinine), on the same biological determination.
Subject previously identified as opposed to the use of their medical data and/or access of their SNDS data,
Subject not registered to the French social security system,
Subject with estimated GFR < 15 ml/min on the day of inclusion
Parallel
Health-related messages
Other interventionPatient will be included in the intervention according to the laboratory's randomization arm.The intervention consists in delivering patient information messages in laboratory reports, providing access to an educational video for patients and a specific message for the prescribing physician in the intervention arm, without modifying patient care.
Major Adverse Renal and Cardiovascular Events (MARCE) occurrence
Change in Major Adverse Renal and Cardiovascular Events (MARCE) occurrence defined as a composite outcome including the following items (first occurring): * All-cause death * Myocardial infarction (universal definition) * Stroke (universal definition) * Sustained (over 45 days) use of renal replacement therapy * Heart failure leading to hospitalization (definition by the European Society of Cardiology)
Specific health outcomes
Change in specific health outcomes (separately analysed): * All-cause death * Myocardial infarction * Stroke * Sustained (over 1 month) use of renal replacement therapy * Heart failure leading to hospitalization * Lower limb amputation, with special information on the site of amputation (toe, transmetatarsal, transtibial, transfemoral) * Arterial revascularization in the coronary, cerebrovascular and/or lower aorta/lower limb territories * Severe diabetic retinopathy (laser procedure, eye surgery for diabetes complication and intravitreal injection associated with specific drug delivery and/or their combinations
Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology
Change in Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology
Biological characteristics
Changes in biological results of: lipids, liver and renal functions, blood cell count, HbA1c, CRP , Blood chemistry and Blood and urine urea
Impact on medical costs
Changes between groups: * in euros of patients healthcare costs, * in type of costs (consultation, hospitalisation, etc), * in euros of the intervention impact, * in QALY of cost-effectiveness
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Nantes University Hospital
Lead sponsor
Hospices Civils de Lyon
Collaborator
University Hospital, Toulouse
Collaborator
University Hospital, Tours
Collaborator
Biogroup Laboratoire de biologie médicale
Collaborator
Santé publique France-InVS (Institut National de Veille sanitaire)
Collaborator
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