Individual and Environmental Risk Factors of Unplanned Admissions of Elderly (RIEHO)

September 11, 2017 updated by: Assistance Publique - Hôpitaux de Paris

Individual and Environmental Risk Factors of Unplanned Admissions of Elderly : RIEHO Inception Cohort

The aim of this multicenter study is to investigate risk factors for unplanned hospitalizations, including individual and environmental factors, notably air pollution.

Study Overview

Status

Completed

Conditions

Detailed Description

Background: Chronic diseases failed concerned people, notably elderly which accumulate them. Failure of failed organ in oldest old citizens (80 and over) often leads to unplanned hospitalization which may have dreadful consequences, such as worsening condition or even death. Few studies have sought to identify all individual and environmental risk factors for unplanned hospitalization of elderly citizens. The development of a nation-wide shared medical record would allow to build an alert system if such factors can be modelled.

Objective: The aim of this multicenter study is to investigate risk factors for unplanned hospitalizations, including individual and environmental factors, notably air pollution. Classifying at risk patients might help preventing unplanned hospitalization of oldest old. Correlations between medical data and the atmospheric pollution modelling will allow us to enhance the forecast system with dose-effect functions. Validation of a multi dimensional standardised instrument (InterRAI-MDS) will help in the development of a shared medical record.

Methods : Patient aged 80 and over presenting to the emergency department (ED) for medical concern eventually associated with social concern and admitted in a medical or surgical ward. Three hospitals, two located in the Paris area and one in Champagne, offering emergency care and providing geriatric services will be involved in the study. 1,200 patients will be prospectively included in the study during a one-year period.

  1. Individual study

    Data collection involves three steps (before, during and after health event) from hospital admission (i.e. study inclusion) and relies on a multi dimensional standardized geriatric assessment using well established scales :

    Retrospective data collection includes medical history, health care utilization, SOCIO-economic status and functional status the days before hospital admission ; Data collection at hospital admission includes functional, mental, nutritional and depression status assessed by geriatric physician and nurse (standardized geriatric assessment) ; social support and care plan will be recorded at discharge ; SOCIO-economic conditions will also be recorded Data collection during follow-up includes health and functional status assessed at three, six, nine months and one year after first emergency visit, with help of the family and family physician. Hospitalizations and death will be recorded.

  2. Environmental and contextual data Meteorological data as well as data on pollution, epidemics, strikes in health care system or public transportation and public holiday will be gathered during the study period. The use of the atmospheric transport chemistry model CHIMERE will give greater spatial (2 to 3 km) and temporal (hour) resolution than airborne measurements of pollutants.
  3. Analysis A bidirectional case-crossover design will be used. Cases serve as their own controls through the use of information on the study subjects both before and after the event (hospitalization). Conditional logistic regression will then be used to investigate the short-term health effects of air pollution while taking into account individual characteristics.

Survival analysis with time dependant covariates (environmental factors) will give strengthening results.

A multi dimensional analysis will be performed to determine cluster of patients and patterns of environmental parameters.

Validation of the RAI-MDS instrument will rely on internal coherency, structural validity and external validity facing usual geriatric scales (ADL, IADL, MMSE, MNA, GDS).

Perspectives Identification of individual risk factors as well as evaluation of environmental threat for older people, potentialized by the setting of medical shared across caregivers could allow to develop individualized alarm and prevention systems.

Study Type

Observational

Enrollment (Actual)

973

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Boulogne Billancourt, France, 92100
        • Hopital Ambroise Pare
      • Reims, France, 51092
        • Service de Court Séjour Gériatrique, CHU DE REIMS, HOPITAL MAISON-BLANCHE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient aged 80 and over presenting to the emergency department (ED) for medical concern eventually associated with social concern and admitted in a medical or surgical ward

Description

Inclusion Criteria:

  • Patient aged 80 and over presenting to the emergency department (ED) for medical concern eventually associated with social concern and admitted in a medical or surgical ward.
  • Three hospitals, two located in the Paris area and one in Champagne, offering emergency care and providing geriatric services will be involved in the study.

Exclusion Criteria:

  • Refusal of the patient or of helping him to sign informed consent
  • Refusal of the patient or of helping him to answer
  • Premature exit before initial examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Factor to explain is unplanned hospitalizations, it will also look into the institution or death, the factors are individual characteristics (medical, functional) and environmental (family, social, physical)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Typology of elderly people
Time Frame: 3 years
3 years
Types of weather patterns and environmental
Time Frame: 3 years
3 years
Modeling of pollution levels and a dose-response relationship
Time Frame: 3 years
3 years
Validity of questionnaire RAI (Resident Assessment Instrument): reproducibility, internal consistency, validity of structure and against criterion
Time Frame: 3 years
3 years
Appropriateness of hospital admissions
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Philippe Aegerter, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2009

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ageing

3
Subscribe