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临床试验/NCT05566145
NCT05566145进行中(未招募)不适用

Evaluation of a Back-to-home Support Program for Hospitalized Patients for Heart Failure

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 616 人开始时间: 2020年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
616
试验地点
1
主要终点
Impact of the PRADO program on morbidity and mortality

研究概览

简要总结

The prevalence of heart failure is very high worldwide is between 1 and 2% in developed countries.

The French Federation of Cardiology estimates that a million people are affected in France. Each year in France, there are nearly 70,000 deaths linked to heart failure, and more than 150,000 hospitalizations with an average cumulative duration per year of 12.7 days, figures which show the extent of the phenomenon. Heart failure is therefore a common pathology, which constitutes an important public health issue. It requires rigorous monitoring and early adaptation of treatments to avoid repeated hospitalizations. Studies show that following hospitalization for heart failure, all-cause re-hospitalization rates rise to 18% within 30 days. In 2019, the rate of re-hospitalization at 1 year is 30%, half of which in the following 3 months. The prognosis is grim with 20 to 30% of deaths within the year.

The European Society of Cardiology recommends that the patient be integrated into a care path coordinated by the general practitioner; and a consultation with his general practitioner in the week after hospitalization and his cardiologist within two weeks. The CPAM (Caisse Primaire d'Assurance Maladie) has set up since 2013 the PRADO-IC program (Program for Return to Home Hospital for Heart Failure). This program must be in place before discharge from hospital. A health insurance advisor comes to meet the patient, declared eligible for PRADO by the hospital medical team, to present the offer and collect his approval before discharge. He then contacts the attending physician and organizes his return home. A follow-up book is given to the patient to allow better transmission of information between town and hospital.

A specially trained nurse visits the patient's home every week. The duration of PRADO support varies according to the NYHA stage of severity. It provides therapeutic education with reinforcement of hygieno-dietetic rules, warning signs, checks compliance with treatments and the necessary biological monitoring and must alert the attending physician in the event of aggravation.

The objectives of this program are: to preserve the quality of life and the autonomy of patients, to support the reduction of the length of stay in hospital, to strengthen the quality of care in town around the attending physician, improve the efficiency of recourse to hospitalization by reserving the heaviest structures for the patients who need them most.

详细描述

The prevalence of heart failure is very high worldwide: according to the European Society of Cardiology, it is between 1 and 2% in developed countries.

The French Federation of Cardiology estimates that a million people are affected in France. This prevalence increases sharply with age, reaching 15% of people aged 85 and over.

Each year in France, there are nearly 70,000 deaths linked to heart failure, and more than 150,000 hospitalizations with an average cumulative duration per year of 12.7 days, figures which show the extent of the phenomenon. In addition, the aging of the population and the explosion of cardiovascular risk factors suggest that the impact of heart failure will be greater in the future.

Heart failure is therefore a common pathology, which constitutes an important public health issue. It requires rigorous monitoring and early adaptation of treatments to avoid repeated hospitalizations. Studies show that following hospitalization for heart failure, all-cause re-hospitalization rates rise to 18% within 30 days. According to a report from the Caisse Primaire d'Assurance Maladie (CPAM) in 2019, the rate of re-hospitalization at 1 year is 30%, half of which in the following 3 months. The prognosis is grim with 20 to 30% of deaths within the year.

The European Society of Cardiology recommends that the patient be integrated into a care path coordinated by the general practitioner; and a consultation with his general practitioner in the week after hospitalization and his cardiologist within two weeks. But general practitioners deplore a lack of coordination between city and hospital with difficulties in taking care of their patient following hospitalization. According to the CPAM report, only 30% of re-hospitalized patients had contact with a cardiologist before their readmission, and 15% of patients had no contact with the health care system within 2 months of followed their hospitalization.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For the PRADO Cohort
  • Male or female whose age is ≥ 18 years
  • Patient hospitalized for heart failure in the GHPSJ Cardiology Department between September 2016 and December 2018 included in the PRADO program
  • Patient affiliated to a CNAM IDF social security scheme (general scheme a priori)
  • Patient understanding the research issues
  • For the control cohort
  • Male or female whose age is ≥ 18 years
  • Patient hospitalized for congestive heart failure (ICD 10 code I500) or left ventricular failure (ICD 10 code I501) in the GHPSJ Cardiology department between September 2016 and December 2018
  • Patient affiliated to a social security scheme CNAM IDF
  • Patient discharged to home
  • Not included in the PRADO program
  • Patient who understands the research issues

排除标准

  • Patient transferred to another establishment or service (surgery, follow-up care, EHPAD...)
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient at the end of life whose vital status is engaged
  • Patient who objects to the use of his data

结局指标

主要结局

Impact of the PRADO program on morbidity and mortality

时间窗: Year 1

This outcome corresponds to the combined rate of all-cause mortality and all-cause re-hospitalization at 1 year, wherever it occurred.

次要结局

  • Mortality at 1 year(Year 1)
  • Time limit for the use of professionals(Year 1)
  • First re-hospitalization(Year 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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