Efficacy of PRADO Heart Failure in Occitania
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 404
- Locations
- 2
- Primary Endpoint
- Cost-efficacy ratio
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cost-efficacy ratio
Time Frame: 12 months
Cost to avoid an hospitalization for heart failure
Secondary Outcomes
- Number of general practitionner(12 months)
- Number of cardiologist visits(12 months)
- Cost-utility ratio(12 months)
- Number of all causes hospitalization(12 months)
- Number of hospitalization for heart failure(12 months)
- Rate of death from cardiovascular disease(12 months)