Back to resultsPatient Care Management Strategies for Severe Heart Failure in Rhône-Alpes, France. (EFFICARD)
Primary Purpose
Severe Heart Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PRETICARD patient care management
"As usual " patient care management
Sponsored by
About this trial
This is an interventional health services research trial for Severe Heart Failure focused on measuring Heart failure, patient education as topic, patient care management
Eligibility Criteria
Inclusion Criteria:
- Chronic heart failure patient with left ventricular ejection fraction (LVEF) defined by an impaired LVEF less than or equal to 40%.
- Heart failure stage III or IV NYHA, or heart failure patients with stage II NYHA with previous hospitalization for heart failure.
- Patient who has received a written or oral information of the study
- Patient affiliated with French health Insurance
Exclusion Criteria:
- Patient refusal to participate in the study
- Progressive neoplastic pathology.
- Patient with impaired cognitive functions known.
- Patient subject to a measure of socio-legal protection.
- Heart failure secondary to curable causes (an arrhythmia, valvular dysfunction, myocardial infarction, bypass surgery scheduled, aortic stenosis, breaking rope…)
- Dyspnea pulmonary origin: pulmonary arterial hypertension pre-capillary origin catheterization, defined by a Pcap ≤15 mmHg.
- Patient who underwent ventricular mechanical assistance.
- Patient with acute breathlessness is explained by: a severe lung infection (CPT <60% of predicted, ventricular ejection fraction <60% predicted) or pulmonary embolism or respiratory failure with ambient air PaO2 (arterial oxygen pressure) below 60 mmHg or oxygen therapy.
- Dialysis patient
Sites / Locations
- Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Interventional
Control
Arm Description
PRETICARD patient care management
Heterogenous "as usual" patient care management.
Outcomes
Primary Outcome Measures
Composite endpoint combining the proportion of patients who died, the proportion of hospitalization for heart failure as well as the proportion of emergency visits for heart failure.
Secondary Outcome Measures
Unplanned re hospitalization rate or emergency consultations for cardiac insufficiency.
Quality of life.
MINNESOTA Questionnaire.
Satisfaction.
Semi-structured interviews.
Cost of medical care
Identification of expenditure:
Hospitalizations
Consultations (inpatient and outpatient)
Biology and imaging
Medical transport
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02763670
Brief Title
Patient Care Management Strategies for Severe Heart Failure in Rhône-Alpes, France.
Acronym
EFFICARD
Official Title
Comparison of Patient Care Management Strategies of Heart Failure in the Rhône-Alpes Region. A Clinical and Economic Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The heart failure is a chronic pathology with prevalence from 2 to 3% of general population, a death rate of 50% at 6 months for patients with stage IV, and a probability of death or hospitalization or emergency consultation of 40% at 3 years. The care of patients is heterogeneous, especially in light of the organization of therapeutic education offered to patients and patient monitoring modalities.
The aim of this study is to investigate the management strategies for patients with chronic heart failure stage III or IV NYHA, and heart failure patients with stage II NYHA with previous hospitalization for heart failure.
This is a longitudinal observational multicenter study comparing a management strategy including patient education and monitoring as part of a hospital dedicated organization and an organization of care as usually done in France.
The primary endpoint was a composite endpoint of morbidity and mortality involving deaths, unplanned readmissions and emergency visits for heart failure.
The expected number of patients is 720 patients (360 per strategy). The follow-up duration of 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Heart Failure
Keywords
Heart failure, patient education as topic, patient care management
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Other
Arm Description
PRETICARD patient care management
Arm Title
Control
Arm Type
Other
Arm Description
Heterogenous "as usual" patient care management.
Intervention Type
Other
Intervention Name(s)
PRETICARD patient care management
Intervention Description
A standardized and specialized network to take care of the severe cardiac insufficiency:
An initial assessment and consultations with health professionals specialized in severe cardiac insufficiency during the hospitalization for cardiac insufficiency
At 1 months, consultations and acts realized by health professionals specialized (one hospital day care)
At 2 months, a therapeutic education program for heart failure patients, approved by the Rhône-Alpes regional public health authorities (week hospital: two days and one night).
At 6 and 18 months, one cardiology consultation
At 12 and 24 months, consultations and acts realized by health professionals specialized (one hospital day care)
Intervention Type
Other
Intervention Name(s)
"As usual " patient care management
Intervention Description
Conventional management of heart failure patients is defined in the guide HAS ("Haute Autorité de Santé") care course. Patient follow-up, however, is defined by the patient's physician and / or cardiologist at the waning of his hospitalization, according to the usual practice for patients with stage II, III or IV NYHA.
According to these recommendations, the patient should see his cardiologist at least once a year.
Usual practices are:
An initial assessment and consultations with health professionals specialized in severe cardiac insufficiency during the hospitalization for cardiac insufficiency
At 12 months, a cardiologic consultation. For the study, three evaluation points are programmed: two by phone at 6 and 18 months, two by a consultation at 24 months. This interview aimed to evaluate the number of hospitalization, consultations and acts realized by health professionals specialized (the information in the logbook).
Primary Outcome Measure Information:
Title
Composite endpoint combining the proportion of patients who died, the proportion of hospitalization for heart failure as well as the proportion of emergency visits for heart failure.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Unplanned re hospitalization rate or emergency consultations for cardiac insufficiency.
Time Frame
At 6, 18 and 24 months
Title
Quality of life.
Description
MINNESOTA Questionnaire.
Time Frame
12 months
Title
Satisfaction.
Description
Semi-structured interviews.
Time Frame
3 months
Title
Cost of medical care
Description
Identification of expenditure:
Hospitalizations
Consultations (inpatient and outpatient)
Biology and imaging
Medical transport
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic heart failure patient with left ventricular ejection fraction (LVEF) defined by an impaired LVEF less than or equal to 40%.
Heart failure stage III or IV NYHA, or heart failure patients with stage II NYHA with previous hospitalization for heart failure.
Patient who has received a written or oral information of the study
Patient affiliated with French health Insurance
Exclusion Criteria:
Patient refusal to participate in the study
Progressive neoplastic pathology.
Patient with impaired cognitive functions known.
Patient subject to a measure of socio-legal protection.
Heart failure secondary to curable causes (an arrhythmia, valvular dysfunction, myocardial infarction, bypass surgery scheduled, aortic stenosis, breaking rope…)
Dyspnea pulmonary origin: pulmonary arterial hypertension pre-capillary origin catheterization, defined by a Pcap ≤15 mmHg.
Patient who underwent ventricular mechanical assistance.
Patient with acute breathlessness is explained by: a severe lung infection (CPT <60% of predicted, ventricular ejection fraction <60% predicted) or pulmonary embolism or respiratory failure with ambient air PaO2 (arterial oxygen pressure) below 60 mmHg or oxygen therapy.
Dialysis patient
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Care Management Strategies for Severe Heart Failure in Rhône-Alpes, France.
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