Pneumonia Clinical Trial
— PIANOOfficial title:
Prevention of pneumonIA in Nursing hOme
Verified date | June 2023 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Infections in nursing home are associated with high morbidity and mortality. Pulmonary infections are known to be the most problematic. In our INCUR observational study of 773 residents, 20.13% of residents had pneumonia during the year of follow-up. On average, the extra cost of pneumopathies was 4,467 euros / patient for the long-term care facility and 3,044 euros for the hospital.
Status | Completed |
Enrollment | 3818 |
Est. completion date | June 5, 2023 |
Est. primary completion date | June 5, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Living in a nursing home for at least 30 days at the start of inclusions, - Having received information concerning the study and having not expressed opposition to participate, - For which an agreement in principle of the attending physician has been obtained. Exclusion Criteria: - Refusal of the resident (or of his legal representative) or of his treating physician after given information, - Resident at the end of life (life expectancy evaluated within one month by the coordinating physician), - Resident whose attending physician is already involved in the PIANO study under a resident of another nursing home. |
Country | Name | City | State |
---|---|---|---|
France | University Hospital Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The comparison of the incidence of lung disease number between the two groups | After the one-year : to compare of the incidence of lung disease between the two groups of Nursing home (the on-line formation/casual care) The diagnosis of pneumopathy will be defined on the criteria of the Infectious Risk Observatory in Geriatrics that are appropriate for nursing home residents, with at least two of the criteria defined for pneumonia | 1 year | |
Primary | Number of Medical evidence of rattles or crepitates | Medical evidence of rattles or crepitates on chest auscultation : rattles or crepitates are criteria for the diagnosis of pneumopathy | 1 year | |
Secondary | Establish a differential cost-effectiveness ratio at 1 year of the care of the residents in nursing home | Establish a differential cost-effectiveness ratio at 1 year of the care of the residents in nursing home by a healthcare team trained in the management of pneumonia in the context of E-learning training versus usual care. The medico-economic analysis will consist in a cost-effectiveness evaluation of a training in the prevention of pneumopathies aimed at the carers in nursing homes, compared to the usual practice. |
1 year | |
Secondary | Evaluation of the time spent by the health care team to support the patient between two groups | Perform an evaluation of the time spent by the health care team to support the patient for Basic Activities of Daily Living (ADL), Instrumental Activities of Daily Living, supervision of care and patient monitoring. They will use the Questionnaire adapted from Resource Utilization in Dementia - Formal Care (RUD-FOCA) | 1 year | |
Secondary | Evaluating the incidence of all-cause hospitalizations | Evaluating the incidence of number of all-cause hospitalizations to compare with the hospitalizations due to pneumonia | 1 year | |
Secondary | Evaluate the evolution of quality of care indicators in the nursing home | Indicators of quality of care in the nursing home related to the risk of pneumonia will be reported at T-2 months and T12 months. These indicators will be provided by the coordinating physician : Vaccination rate (Residents; Staff). Presence in the nursing home of a protocol for taking care of the false route In case of pneumopathy, the use of antibiotic therapy will be indicated |
1 year | |
Secondary | Functional decline of residents | The degree of dependence of the residents will be evaluated by the carers of the nursing home by the Scale ADL (Basic Activity Daily Living) of Katz during 12 months On this scale of 0 (totally dependent) to 6 points (independent), a difference of 0.5 points would be considered clinically relevant. | 1year |
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