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

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.

Conditions

• Severe Heart Failure

Interventions

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

"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).

Sponsors & Collaborators

• Hospices Civils de Lyon

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• France

Study Locations