Prevention of pneumonIA in Nursing hOme (PIANO)

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Other: On-line training; Other: Usual practice

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 3818
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nursing home with On-line training; 25 randomized residents will be included by nursing home Half of the institutions (randomized too) will benefit from an "on-line" training on the prevention and management of resident lung diseases	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).
Active Comparator: Nursing home with usual practice; This group of Institutions continue their usual practice (routine care) and will not benefit from training during the study period.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Yves Rolland, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): June 5, 2023
• Study Completion (Actual): June 5, 2023

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Prevention; Nursing home
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: RC31/17/0452

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No