Prevention of pneumonIA in Nursing hOme

Pneumonia Clinical Trial

— PIANO  

Official title:

Prevention of pneumonIA in Nursing hOme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121182
• Other study ID #: RC31/17/0452
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: June 5, 2023

Study information

• Verified date: June 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The pneumopathies in nursing home are the main cause of hospitalization of residents. Depending on the series, 9 to 50% of residents with pneumonia should be transferred. This reflects the difficulties faced by nursing home care teams in these situations. The respiratory symptomatology of nursing home residents is difficult to grasp and the prescribed antibiotic therapy is often considered inappropriate (25% to 75% of cases). Prevention of resident pneumonia, such as vaccination against pneumococcus remains poorly practiced, influenza vaccination teams or vitamin D supplementation. In addition to the risk of mortality, lung diseases are often the cause of a rapid functional decline. Preventing pneumonia in nursing homes is therefore an important issue in the prevention of dependence, the quality of life, the health care system (use of hospitalization and transfer to emergencies) and health expenditure. In this vulnerable population, a prevention intervention seems particularly relevant. In this research project, the investigators hypothesize that a multi-domain prevention intervention for pneumonia carried out by nursing teams in nursing homes can reduce the incidence of pneumonia. They also believe that this action would reduce emergency transfers and health expenditures.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Pneumonia

Intervention

Other:
• On-line training
Nursing teams randomized in the intervention group will benefit from an intervention in the form of a specific training "online" on the prevention of pneumonia and their management in the nursing home This training focuses on prevention, and management during the infectious period (the false food route and the management of pneumonia).
• Usual practice
Nursing home with usual practice : The act of comparison is defined by the usual care, as they are performed in the nursing home at the time of the study. No restrictions are placed on residents or caregivers of any kind in the care of the resident.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

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