PIANO: Prevention of pneumonIA in Nursing hOme

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT04121182
Collaborator
Ministry of Health, France (Other)
7,000
1
2
46.4
150.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: On-line training
  • Other: Usual practice
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
7000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Seven thousand residents will be recruited by 280 nursing home in 2 major regions in France (Occitanie and Auvergne-Rhônes-Alpes) and followed for 1 year. At the end of the randomization, half of the institutions will benefit from an "on-line" training on the prevention and management of pulmonary disease in residents. Other institutions will continue their usual practice (routine care) and will not benefit from training during the study period.Seven thousand residents will be recruited by 280 nursing home in 2 major regions in France (Occitanie and Auvergne-Rhônes-Alpes) and followed for 1 year. At the end of the randomization, half of the institutions will benefit from an "on-line" training on the prevention and management of pulmonary disease in residents. Other institutions will continue their usual practice (routine care) and will not benefit from training during the study period.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prevention of pneumonIA in Nursing hOme
Actual Study Start Date :
Oct 19, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Toulouse Toulouse France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse
  • Ministry of Health, France

Investigators

  • Principal Investigator: Yves Rolland, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04121182
Other Study ID Numbers:
  • RC31/17/0452
First Posted:
Oct 9, 2019
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022