Efficacy of PRADO Heart Failure in Occitania

Study Overview
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Brief Summary
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Patients with heart failure (IC), after hospitalization, have a marked fragility: in France, in the first year, 29% die and 45% are readmitted to IC. Interventions improving the coordination of care providers at the time of discharge from hospitalization were tested; they showed a reduction in readmissions for IC (relative risk (RR) from 0.51 to 0.74) and all-cause mortality (RR 0.75 to 0.87). The Patient Return Program IC (PRADO IC), set up by the Health Insurance, offers assistance in the initiation of outpatient medical monitoring, and a nursing follow-up of 2 to 6 months depending on the patient's severity. The trial of PRADO began in the second half of 2013, and the first evaluation showed that the time to first treatment was significantly shorter, and that the readmissions rate and the 6-month death rate were unchanged. This study was of epidemiological type, comparative before-elsewhere. The difficulty of controlling for confounders in this type of study limits the scope of these conclusions. The efficacy hypothesis of PRADO IC is therefore always posed in the French context

Official Title
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Efficacy of PRADO Heart Failure in Occitania

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: PRADO-IC
* Behavioral: No intervervention Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Hospitalization for heart failure Subject living at home Informed consent Exclusion criteria: discharge to a rehabilitation clinic or to medical home for elderly people subject without health insurance terminal kidney failure programmed heart surgery waiting for heart transplantation psycho-cognitive impairment patient not autonomous for mobility at home supportive care planned move to medical home for elderly people in the coming 6 months no fluent french not able to provide informed consent participating to other study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRADO-IC<br> | Behavioral: PRADO-IC<br>* Help of administrative employees to schedule the first medical visits after an hospitalization for heart failure. Home nurse's visiting program, during 2 to 6 months after the hospitalization for heart failure.<br>|
| Other: Usual care<br> | Behavioral: No intervervention Usual Care<br>* Advices about the care pathway, provided by care givers. Prescription of home nurse's visits if needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-efficacy ratio | Cost to avoid an hospitalization for heart failure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-utility ratio | Cost will be performed from the society perspective. Utility will be derived from the French EQ5D, measured at 0, 6 and 12 months | 12 months | 
| Number of hospitalization for heart failure | Hospitalizations for heart failure will be defined using claim data. | 12 months | 
| Number of all causes hospitalization |  | 12 months | 
| Rate of death from cardiovascular disease |  | 12 months | 
| Number of general practitionner | Claim data | 12 months | 
| Number of cardiologist visits | Claim data | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Care pathway, Transition program, Efficiency