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Completed

NCT Number: NCT04121182

Prevention of pneumonIA in Nursing hOme

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Toulouse

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

On-line training

Other

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

Other

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.

Primary outcomes

  1. The comparison of the incidence of lung disease number between the two groups

    Time frame: 1 year

    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

  2. Number of Medical evidence of rattles or crepitates

    Time frame: 1 year

    Medical evidence of rattles or crepitates on chest auscultation : rattles or crepitates are criteria for the diagnosis of pneumopathy

Secondary outcomes

  1. Establish a differential cost-effectiveness ratio at 1 year of the care of the residents in nursing home

    Time frame: 1 year

    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.

  2. Evaluation of the time spent by the health care team to support the patient between two groups

    Time frame: 1 year

    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)

  3. Evaluating the incidence of all-cause hospitalizations

    Time frame: 1 year

    Evaluating the incidence of number of all-cause hospitalizations to compare with the hospitalizations due to pneumonia

  4. Evaluate the evolution of quality of care indicators in the nursing home

    Time frame: 1 year

    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
  5. Functional decline of residents

    Time frame: 1year

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: PIANO

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 9, 2019
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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