Frail Elderly Subjects - Evaluation and Follow-Up

Frail Elderly People Clinical Trial

— SAFES Cohort  

Official title:

Frail Elderly Subjects: Inhospital Pathways and Adverse Outcome After Hospitalisation Via Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834728
• Other study ID #: 44N98
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: July 22, 2016
• Start date: March 2001
• Est. completion date: December 2005

Study information

• Verified date: July 2016
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial Summary

This was a prospective multicenter cohort study of elderly people admitted to medical wards via emergency departments. Subjects were followed up to 36 months. It aimed to study the inhospital pathways and adverse geriatric outcomes. In all, 1306 subjects were included : 85+/-5 years, and mainly women (65%).

Description:

The SAFES cohort was formed within a National Research Program (funded by the French Ministry of health) into the recruitment of emergency units in nine teaching hospitals. All nine centres had a geriatric ward. The inclusion of subjects ran from March 1st 2001 to January 17th 2002. To be eligible, patients were to be 75 or over, to have been hospitalised in a medical ward in the same hospital as the emergency unit to which they were initially admitted. Subjects were not eligible if hospitalisation was into intensive care or surgery, or if admission did not occur after admission to the emergency unit. Every day in each centre, patients admitted to the emergency unit were registered. From the list thus obtained, patients were selected by random draw stratified at two levels: in each week, 5 days were selected randomly, and for each of these days, two patients were chosen randomly. Next, each patient was visited by a specialist in geriatrics familiar with the survey procedures. In the course of this interview, patients were informed about the study, prior to signing the consent form. If the clinical status and/or the cognitive status of the patient did not enable informed consent, the interviewer referred to the subject's representative. Follow-up was by telephone interview after the 1st, 8th and 21st month and by face-to-face interviews after the 5th, 12th, 18th, and 24th month following the initial hospitalisation. Several outcome have been studied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1306
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Age of 75 years or over

• Admitted to medical ward via emergency department

• Consent to participate

Exclusion Criteria:

• Not hospitalised after emergency department stay

• Admitted to surgery or intensive car unit

• Died before signing informed consent form

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Frail Elderly People

Intervention

Behavioral:
• telephone interview

Locations

Country	Name	City	State
France	Chu Reims	France	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (22)

de Boissieu P, Mahmoudi R, Hentzien M, Toquet S, Novella JL, Blanchard F, Jolly D, Dramé M. Predictors of Long-Term Mortality in Oldest Old Patients (90+) Hospitalized to Medical Wards via the Emergency Department: The SAFES Cohort. J Nutr Health Aging. 2 — View Citation

Dhaussy G, Dramé M, Jolly D, Mahmoudi R, Barbe C, Kanagaratnam L, Nazeyrollas P, Blanchard F, Novella JL; SAFES Group. Is health-related quality of life an independent prognostic factor for 12-month mortality and nursing home placement among elderly patie — View Citation

Dramé M, Dia PA, Jolly D, Lang PO, Mahmoudi R, Schwebel G, Kack M, Debart A, Courtaigne B, Lanièce I, Blanchard F, Novella JL. [Factors predictive of long-term mortality in patients aged 75 years or older hospitalized from the emergency department: the SA — View Citation

Dramé M, Fierobe F, Lang PO, Jolly D, Boyer F, Mahmoudi R, Somme D, Laniece I, Heitz D, Gauvain JB, Voisin T, De Wazieres B, Gonthier R, Ankri J, Saint-Jean O, Couturier P, Jeandel C, Blanchard F, Novella JL. Predictors of institution admission in the yea — View Citation

Drame M, Jovenin N, Novella JL, Lang PO, Somme D, Laniece I, Voisin T, Blanc P, Couturier P, Gauvain JB, Blanchard F, Jolly D. Predicting early mortality among elderly patients hospitalised in medical wards via emergency department: the SAFES cohort study — View Citation

Dramé M, Lang PO, Jolly D, Narbey D, Mahmoudi R, Lanièce I, Somme D, Gauvain JB, Heitz D, Voisin T, de Wazières B, Gonthier R, Ankri J, Saint-Jean O, Jeandel C, Couturier P, Blanchard F, Novella JL. Nursing home admission in elderly subjects with dementia — View Citation

Dramé M, Lang PO, Novella JL, Narbey D, Mahmoudi R, Lanièce I, Somme D, Gauvain JB, Heitz D, Voisin T, de Wazières B, Gonthier R, Ankri J, Saint-Jean O, Jeandel C, Couturier P, Blanchard F, Jolly D. Six-month outcome of elderly people hospitalized via the — View Citation

Dramé M, Novella JL, Jolly D, Lanièce I, Somme D, Heitz D, Gauvain JB, Voisin T, De Wazières B, Gonthier R, Jeandel C, Couturier P, Saint-Jean O, Ankri J, Blanchard F, Lang PO. Rapid cognitive decline, one-year institutional admission and one-year mortali — View Citation

Dramé M, Novella JL, Lang PO, Somme D, Jovenin N, Lanièce I, Couturier P, Heitz D, Gauvain JB, Voisin T, De Wazières B, Gonthier R, Ankri J, Jeandel C, Saint-Jean O, Blanchard F, Jolly D. Derivation and validation of a mortality-risk index from a cohort o — View Citation

Lang PO, Dramé M, Jolly D, Novella JL, Blanchard F, Michel JP. [What do we learn from the SAFEs cohort to fit hospital care models for aged inpatient?]. Presse Med. 2010 Nov;39(11):1132-42. doi: 10.1016/j.lpm.2010.05.009. Epub 2010 Jul 1. French. — View Citation

Lang PO, Dramé M, Mahmoudi R, Jolly D, Lanièce I, Saint-Jean O, Somme D, Heitz D, Gauvain JB, Voisin T, de Wazières B, Gonthier R, Jeandel C, Couturier P, Ankri J, Blanchard F, Novella JL. [Frailty: learnings from the SAFEs cohort study and future perspec — View Citation

Lang PO, Heitz D, Hédelin G, Dramé M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Couturier P, Voisin T, De Wazière B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. Early markers of prolonged hospital stays in older people: a prospec — View Citation

Lang PO, Heitz D, Meyer N, Dramé M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Colvez A, Couturier P, Lanièce I, Voisin T, de Wazières B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. [Early indicators of prolonged hospitalization o — View Citation

Lang PO, Mahmoudi R, Novella JL, Tardieu E, Bertholon LA, Nazeyrollas P, Blanchard F, Jolly D, Dramé M. Is obesity a marker of robustness in vulnerable hospitalized aged populations? Prospective, multicenter cohort study of 1 306 acutely ill patients. J N — View Citation

Lang PO, Meyer N, Heitz D, Dramé M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Couturier P, Lanièce I, Voisin T, de Wazières B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. Loss of independence in Katz's ADL ability in connection w — View Citation

Lang PO, Zekry D, Michel JP, Drame M, Novella JL, Jolly D, Blanchard F. Early markers of prolonged hospital stay in demented inpatients: a multicentre and prospective study. J Nutr Health Aging. 2010 Feb;14(2):141-7. — View Citation

Lanièce I, Couturier P, Dramé M, Gavazzi G, Lehman S, Jolly D, Voisin T, Lang PO, Jovenin N, Gauvain JB, Novella JL, Saint-Jean O, Blanchard F. Incidence and main factors associated with early unplanned hospital readmission among French medical inpatients — View Citation

Narbey D, Jolly D, Mahmoudi R, Trenque T, Blanchard F, Novella JL, Dramé M. Relationship between anticholinergic drug use and one-year outcome among elderly people hospitalised in medical wards via emergency department: the SAFES cohort study. J Nutr Heal — View Citation

Prudent M, Dramé M, Jolly D, Trenque T, Parjoie R, Mahmoudi R, Lang PO, Somme D, Boyer F, Lanièce I, Gauvain JB, Blanchard F, Novella JL. Potentially inappropriate use of psychotropic medications in hospitalized elderly patients in France: cross-sectional — View Citation

Somme D, Lazarovici C, Dramé M, Blanc P, Lang PO, Gauvain JB, Voisin T, Gonthier R, De Wazières B, Jeandel C, Couturier P, Blanchard F, Saint-Jean O. The geriatric patient: use of acute geriatrics units in the emergency care of elderly patients in France. — View Citation

Tardieu É, Mahmoudi R, Novella JL, Oubaya N, Blanchard F, Jolly D, Dramé M. [External validation of the short emergency geriatric assessment (SEGA) instrument on the SAFES cohort]. Geriatr Psychol Neuropsychiatr Vieil. 2016 Mar;14(1):49-55. doi: 10.1684/p — View Citation

Viatonou S, Dramé M, Jolly D, Morrone I, Lang PO, Voisin T, Boyer FC, Schwebel G, Somme D, Blanchard F, Novella JL. Predictors of rapid cognitive decline among demented subjects aged 75 or more: ('Sujet Agé Fragile--Evaluation et Suivi' Cohort-SAFES). Int — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		up to 36 months	No