Prevention of pneumonIA in Nursing hOme

NCT04121182 | Completed

• 1 other identifier: RC31/17/0452
• Study Type: interventional
• Target: 3,818
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Keywords

Nursing home; Prevention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

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

  1 year

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

  1 year

• Evaluating the incidence of all-cause hospitalizations

  1 year

• Evaluate the evolution of quality of care indicators in the nursing home

  1 year

• Functional decline of residents

  1year

Study Arms (2)

Nursing home with On-line training

EXPERIMENTAL

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 home with usual practice

ACTIVE COMPARATOR

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

Other: Usual practice

Interventions

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).

Nursing home with On-line training

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.

Nursing home with usual practice

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Ministry of Health, France: collaborator

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yves Rolland, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: October 9, 2019
• Study Start: October 19, 2020
• Primary Completion: June 5, 2023
• Study Completion: June 5, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

FR (1)