Patient Care Management Strategies for Severe Heart Failure in Rhône-Alpes, France. (EFFICARD)

Comparison of Patient Care Management Strategies of Heart Failure in the Rhône-Alpes Region. A Clinical and Economic Study.

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.

Study Overview

• Status: Completed
• Conditions: Severe Heart Failure
• Intervention / Treatment: Other: PRETICARD patient care management; Other: "As usual " patient care management

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Interventional; PRETICARD patient care management	Other: PRETICARD patient care management; 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)
Other: Control; Heterogenous "as usual" patient care management.	Other: "As usual " patient care management; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned re hospitalization rate or emergency consultations for cardiac insufficiency.		At 6, 18 and 24 months
Quality of life.	MINNESOTA Questionnaire.	12 months
Satisfaction.	Semi-structured interviews.	3 months
Cost of medical care	Identification of expenditure: Hospitalizations; Consultations (inpatient and outpatient); Biology and imaging; Medical transport	24 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Heart failure; patient care management; patient education as topic
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2013.838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO