Frailty Screening in the Swedish Emergency Department Setting

Sponsor
University Hospital, Linkoeping (Other)
Overall Status
Completed
CT.gov ID
NCT04877028
Collaborator
(none)
1,800
1
5.9
302.7

Study Details

Study Description

Brief Summary

This prospective observational study will investigate the correlation of frailty in relation to serious outcomes. Serious outcomes are defined as: mortality within 30 days, admission to hospital, length of stay in the Emergency Department(ED), in hospital length of stay and revisits to the ED.

The exposure, frailty, will be assessed according to Clinical Frailty Scale. ED patients >65 years of age in a Swedish regional health care system (Region Östergötland, Sweden) comprising three EDs in Linköping, Norrköping and Motala. The outcomes will be compared according to the degree of frailty and censored over 7, 30 and 90 days respectively.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Frailty is a common clinical syndrome in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalization, and mortality.

    The clinical frailty scale (CFS) is a measure of frailty based on clinical judgement in a 9 level scale, categorized as "vulnerable" (1-4), "mildly frail" (5), moderatly frail (6) and severely and very severely frail (7-8).". A validation study of the CFS in community-dwelling older people showed that it performed better than measures of cognition, function or comorbidity in assessing risk for death. In a prospective observational study including consecutive ED patients aged 65 years or older The Hosmer-Lemeshow test indicated a good agreement between predicted probability and observed frequency of 30-day mortality and ICU admission.

    The aim of this study will be to investigate if the fraily, assessed according to CFS, is associated with increased 30-day mortality. in a Swedish Emergency Care context. Secondary outcomes included 7-and 90-day mortality, ED length of stay, hospital admission, hospital length of stay, subsequent falls and medication changes. Additionally, we collect data on morbidity and comorbidities to assess the association with the level of frailty. Since this is a multicenter study, possible geographic differences will be studied as well. Based on the results of this study, possible interventions could be identified to improve the care of the frail geriatric patients presenting at the ED.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Frailty Screening in the Swedish Emergency Department Setting
    Actual Study Start Date :
    May 17, 2021
    Actual Primary Completion Date :
    Nov 14, 2021
    Actual Study Completion Date :
    Nov 14, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Mortality in 30 days [All cause mortality up to 90 days from index visit]

      Investigate level of mortality in cohort at 30 days

    Secondary Outcome Measures

    1. Mortality in 7 and 90 days [All cause mortality up to 90 days from index visit]

      Investigate level of mortality in cohort at 7 and 90 days

    2. Admission to hospital [Hospital admission on index visit, censored at 90 days]

      Investigate level of all cause admissions in cohort

    3. ED length of stay [Length of stay at ED, censored at 4 days]

      Investigate length of stay at ED

    4. Hospital length of stay [Hospital length of stay from index visit, censored at 90 days]

      Investigate hospital length of stay

    5. Revisitis to the ED [Number of newly registered visits to the emergency department after index visit, censored at 90 days]

      Number of newly registered visits to the emergency department after index visit

    6. Fall prevalence after the index visit [Falls that resulted in further ED visits after index visit, censored in 90 days]

      Falls that resulted in further ED visits

    7. Alterations in medication during the visit (based on codes for Anatomical, Therapeutic, Chemical classification (ATC-code)) [Alterations in medications from index visit and during the follow-up period, censored at 90 days]

      Alterations in medication and during the follow-up period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ≥65 years, able to answer any questions, alternatively have a proxy
    Exclusion Criteria:
    • Patients: <65 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Linköping Linköping Östergötland Sweden 58185

    Sponsors and Collaborators

    • University Hospital, Linkoeping

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Daniel Wilhelms, Principal Investigator, University Hospital, Linkoeping
    ClinicalTrials.gov Identifier:
    NCT04877028
    Other Study ID Numbers:
    • 2021-00875FSSED
    First Posted:
    May 7, 2021
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 23, 2022