Heart Diseases, Heart Failure, Heart Valve Diseases
Conditions
Keywords
Echocardiography, Nursing Home, Implementation, Heart Failure
Brief summary
The study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes.
Detailed description
Open-label cluster randomized type 1 hybrid trial, with 2 parallel arms: nursing homes will be randomized in the interventional (echocardiography by sonographer) or non-interventional arms (usual care). In the interventional arm echocardiography will be proposed to all residents of the nursing home at baseline. Clinical management will be adapted to the result of echocardiography by the general practitioner, in accordance with the cardiologist. The main objective is to assess the impact at 12 months of the initial performance of a systematic simplified echocardiography on the rate of nursing home residents presenting with heart failure episode or cardiovascular pathology. The Primary endpoint is the number of nursing home residents presenting a heart failure episode or an unscheduled hospitalization for heart failure or other cardiovascular pathologies at 12 months. Thirty nursing homes and 1050 residents will be included overall
Interventions
DIAGNOSTIC_TESTImplementation of echocardiography in nursing homes
An ultrasound will be carried out in the EHPAD, the result of which will be interpreted by a cardiologist then sent to the establishment and the attending physician with instructions to follow.
Sponsors
Directorate of Health Care Supply
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Masking description
Not relevant
Intervention model description
Nursing home randomization in 1:1 ratio between echocardiography and no-echocardiography
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: Nursing homes residents with a life-expectancy estimated \> 1 year, and able to participate to the study, giving an oral consent
Exclusion criteria
: * no accessible to echocardiography * closed unit (severe Alzheimer disease…) * recent contagious disease such Covid (\<15 days) * no consent to participate * no social security number
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of resident presenting a heart failure decompensation | 12 months | Number of residents with heart failure flare (worsening of at least 1 NYHA class) or unplanned hospitalization for heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of a clinically significative change in medical management and care in the month following ultrasound | 12 months | A binary outcome will be constructed, based on the following algorithm: clinically significative change set to yes if a change in ongoing drug prescription is observed, and/or a cardiologist visit is planned, and/or a geriatrist visit is planned, and/or an hospitalization for clinical work-up is set, and/or a resume of the ultrasound is sent to the GP. Otherwise (all components set to absent), this outcome will be set to None. |
Countries
France
Contacts
Primary ContactThierry LE TOURNEAU, PU-PH
Backup ContactAnne-Sophie BOUREAU, PH
Outcome results
None listed