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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03905629
Other study ID # 69HCL19_0018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date November 30, 2019

Study information

Verified date July 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Older people are increasing users of health care globally. Constraints in bed capacity and resources raise important challenges with regards to management of older people with complex needs, which usually require assertive and holistic assessment. It is important, therefore, to identify aged patients most likely to benefit from such frailty-attuned approaches of care. A previous study using national Hospital Episodes Statistics conducted in the United Kingdom (UK) showed that patients aged over 75 years with characteristics of frailty and at risk of adverse health-care outcomes can be identified using routinely collected data (Gilbert T et al., Lancet 2018). This study lead to the development of the Hospital Frailty Risk Score (HFRS), which is based on International Statistical Classification of Diseases and Related Health Problems 10 (ICD-10) diagnosis codes and has the potential to be used in other countries worldwide, using the ICD-10 coding framework, to identify patients at risk of frailty at the hospital and commissioners levels, as well as for database research purposes. This score has successfully been validated in Canada, Australia and Switzerland. The aim of the present study is to evaluate the ability of the HFRS to predict 30-day in-patient mortality of patients aged 75 years and older admitted to French hospitals as an emergency.


Recruitment information / eligibility

Status Completed
Enrollment 1000000
Est. completion date November 30, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - age 75 years or over (on the day of the index admission) - hospitalized as an emergency (i.e. after visit to ED) Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
None (retrospective observational study)
This multi-centric retrospective observational cohort study is conducted using the PMSI. Predictive ability of HFRS estimated on the basis of 3 binary outcomes: 30-day in-patient mortality (main outcome), 30-day emergency and potentially avoidable readmission, length of stay >15 days. Odds ratios (ORs) and c-statistics calculated and compared to the original UK results in order to validate the use of the HFRS in France. Other secondary objectives include: Evaluate agreement between HFRS and Charlson or Elixhauser comorbidity indices Evaluate ability of HFRS combined with comorbidity indices (Charlson on one hand, and Elixhauser on other hand), to predict 30-day in-patient mortality, 30-day emergency and potentially avoidable readmissions, and long length of stay Identify specific risk associations in France of a high risk of frailty (as assessed by the HFRS) with individual, organizational and territorial factors

Locations

Country Name City State
France service de court séjour gériatrique, Hôpital Lyon Sud Pierre-Bénite

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30-day in-patient mortality The main outcome measure will be 30-day in-patient mortality. Mortality data will be limited to in-hospital mortality, which will be directly available from the PMSI database. In-patient mortality within 30 days from admission (index hospitalization)
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