Incidence of pNeumonia and Related ConseqUences in Nursing Home Residents (INCUR)

Incidence of pNeumonia and Related ConseqUences in Nursing Home

In the present proposal, we hypothesize that specifically targeting pneumonia events with preventive interventions in the French EHPAD (Etablissements d'Hébergement pour Personnes Agées Dépendantes) setting (thus, improving the health status and quality of life of patients) may simultaneously produce relevant reductions in the healthcare costs. In fact, although the number of pneumonia cases may be numerically limited, the consequences of each event are potentially catastrophic for both the patient and the healthcare system. Unfortunately, to date, information about the incidence and economical effects of pneumonia in the older population living in the French EHPAD are extremely scare. To adequately evaluate whether there is room to implement preventive interventions aimed at reducing the onset of pneumonia in a cost-effective fashion on a large scale, preliminary data from this specific population are needed. This first step is crucial towards the appropriate design and conduction of possible future large-scale intervention trials in the EHPAD setting.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Other: Data collection on pneumonia events

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • University Hospital Toulouse

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients living in the participating EHPAD for more than 30 days since the baseline study visit

Description

Inclusion Criteria:

• Groups Iso-Resources (GIR) ranging between 5 (included) and 2 (included)
• Ability and willingness to participate to the study and to provide informed consent
• Agreement with the patient's physician about the enrolment to the study

Exclusion Criteria:

• Refusal of the EHPAD to participate
• Patients with severe disability (GIR 1)
• Patients with no evidence of functional impairment (GIR 6)
• Patients living in the participating EHPAD for less than 30 days since the baseline study visit

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pneumonia	Estimate the incidence of pneumonia events in a sample of 800 older patients living in 30 EHPADs over a period of 12 months	months 12
healthcare costs	To compare the healthcare costs of participants experiencing a pneumonia event versus those who will not in a random sample of 800 older patients living in 30 EHPADs over a period of 12 month	months 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality risk	To calculate the mortality risk in a random sample of 800 EHPAD older patients according to the presence/absence of a pneumonia event occurred during a follow-up period of 12 months	Months 12
Physical Function	To measure the physical function modifications experienced by a random sample of 800 EHPAD older patients according to the presence/absence of a pneumonia event occurred during a follow-up period of 12 months	Months 12

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Study Director: Mateo Cesari, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: elderly
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 11 280 03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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