NCT03905629

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

April 4, 2019

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Patients aged 75 years and older hospitalized as an emergency

Patients considered will be all patients aged 75 years and older (on the day of the index admission) hospitalized as an emergency (i.e. after visit to ED) between january 2017 and december 2017.

Other: None (retrospective observational study)

Interventions

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

Also known as: Validation of the HFRS in Combination With Charlson/Elixhauser Comorbidity Coding Algorithms on the French national PMSI database
Patients aged 75 years and older hospitalized as an emergency

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients considered will be all patients aged 75 years and older hospitalized as an emergency over a one year period ranging from January to December 2017. According to a preliminary extraction, we expect to include approximately one million patients.

You may qualify if:

  • age 75 years or over (on the day of the index admission)
  • hospitalized as an emergency (i.e. after visit to ED)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

service de court séjour gériatrique, Hôpital Lyon Sud

Pierre-Bénite, 69495, France

Location

Related Publications (1)

  • Gilbert T, Cordier Q, Polazzi S, Bonnefoy M, Keeble E, Street A, Conroy S, Duclos A. External validation of the Hospital Frailty Risk Score in France. Age Ageing. 2022 Jan 6;51(1):afab126. doi: 10.1093/ageing/afab126.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 5, 2019

Study Start

April 1, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

July 13, 2022

Record last verified: 2022-07

Locations