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Prevention of pneumonIA in Nursing hOme (PIANO)

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
On-line training
Usual practice
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia focused on measuring Nursing home, Prevention

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nursing home with On-line training

Nursing home with usual practice

Arm Description

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

This group of Institutions continue their usual practice (routine care) and will not benefit from training during the study period.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
August 19, 2019
Last Updated
June 15, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT04121182
Brief Title
Prevention of pneumonIA in Nursing hOme
Acronym
PIANO
Official Title
Prevention of pneumonIA in Nursing hOme
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
June 5, 2023 (Actual)
Study Completion Date
June 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Nursing home, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Seven thousand residents will be recruited by 280 nursing home in 2 major regions in France 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)
Allocation
Randomized
Enrollment
3818 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nursing home with On-line training
Arm Type
Experimental
Arm Description
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
Arm Title
Nursing home with usual practice
Arm Type
Active Comparator
Arm Description
This group of Institutions continue their usual practice (routine care) and will not benefit from training during the study period.
Intervention Type
Other
Intervention Name(s)
On-line training
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Usual practice
Intervention Description
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 Outcome Measure Information:
Title
The comparison of the incidence of lung disease number between the two groups
Description
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
Time Frame
1 year
Title
Number of Medical evidence of rattles or crepitates
Description
Medical evidence of rattles or crepitates on chest auscultation : rattles or crepitates are criteria for the diagnosis of pneumopathy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Establish a differential cost-effectiveness ratio at 1 year of the care of the residents in nursing home
Description
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.
Time Frame
1 year
Title
Evaluation of the time spent by the health care team to support the patient between two groups
Description
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)
Time Frame
1 year
Title
Evaluating the incidence of all-cause hospitalizations
Description
Evaluating the incidence of number of all-cause hospitalizations to compare with the hospitalizations due to pneumonia
Time Frame
1 year
Title
Evaluate the evolution of quality of care indicators in the nursing home
Description
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
Time Frame
1 year
Title
Functional decline of residents
Description
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.
Time Frame
1year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Rolland, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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Prevention of pneumonIA in Nursing hOme

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