Efficacy of PRADO Heart Failure in Occitania (PRADO-IC)
Primary Purpose
Heart Failure
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PRADO-IC
No intervervention Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure focused on measuring Heart Failure, Care pathway, Transition program, Efficiency
Eligibility Criteria
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
Sites / Locations
- CHU Montpellier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
PRADO-IC
Usual care
Arm Description
Outcomes
Primary Outcome Measures
Cost-efficacy ratio
Cost to avoid an hospitalization for heart failure
Secondary Outcome Measures
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
Number of hospitalization for heart failure
Hospitalizations for heart failure will be defined using claim data.
Number of all causes hospitalization
Rate of death from cardiovascular disease
Number of general practitionner
Claim data
Number of cardiologist visits
Claim data
Full Information
NCT ID
NCT03396081
First Posted
December 26, 2017
Last Updated
October 4, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03396081
Brief Title
Efficacy of PRADO Heart Failure in Occitania
Acronym
PRADO-IC
Official Title
Efficacy of PRADO Heart Failure in Occitania
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Care pathway, Transition program, Efficiency
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
404 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRADO-IC
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
PRADO-IC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No intervervention Usual Care
Intervention Description
Advices about the care pathway, provided by care givers. Prescription of home nurse's visits if needed.
Primary Outcome Measure Information:
Title
Cost-efficacy ratio
Description
Cost to avoid an hospitalization for heart failure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cost-utility ratio
Description
Cost will be performed from the society perspective. Utility will be derived from the French EQ5D, measured at 0, 6 and 12 months
Time Frame
12 months
Title
Number of hospitalization for heart failure
Description
Hospitalizations for heart failure will be defined using claim data.
Time Frame
12 months
Title
Number of all causes hospitalization
Time Frame
12 months
Title
Rate of death from cardiovascular disease
Time Frame
12 months
Title
Number of general practitionner
Description
Claim data
Time Frame
12 months
Title
Number of cardiologist visits
Description
Claim data
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy of PRADO Heart Failure in Occitania
We'll reach out to this number within 24 hrs