Loss of Independence - a Rapid Alternative to Frailty Screening in a Swedish ED Setting

Sponsor
University Hospital, Linkoeping (Other)
Overall Status
Completed
CT.gov ID
NCT04888884
Collaborator
(none)
1,800
3
3.1
600
192.2

Study Details

Study Description

Brief Summary

This prospective observational study will investigate the correlation of a surrogate marker 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 Loss of Independence (LOI) a possible low-cost quick tool to identify frailty in patients. The study population will be 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.

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 Loss of Independence (LOI) defined as inability to rise from a chair with or without existing aids, is a possible low cost surrogate marker to measure frailty. Several studies on triage scores for predicting mortality and need of hospital admission have identified LOI as one of the most important variables. LOI was prognostic in ED populations regarding mortality within 1-30 days in Denmark, Ireland and Tanzania. Data from the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) Geriatric Surgery Pilot Project showed that LOI was associated with higher rates of readmission and death after discharge in geriatric patients undergoing surgical procedures6.

    The aim of this study will be to investigate if the frailty, as assessed with LOI, is associated with increased 30-day mortality in a Swedish ED context. Secondary outcomes include 7- and 90-day mortality, ED-length of stay, hospital admission, in-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 multicentre 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:
    Loss of Independence (LOI) - a Rapid Alternative to Frailty Screening in a Swedish Emergency Department Setting
    Actual Study Start Date :
    Sep 27, 2021
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Mortality in 30 Days [All cause mortality up to 30 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. In-hospital length of stay [In-hospital length of stay from index visit, censored at 90 days]

      Investigate in-hospital length of stay

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

      Number of newly registered visits to the ED after index visit

    6. Fall prevalence after index visit [Falls that resulted in further health care contacts after index visit, censored at 90 days]

      Falls that resulted in further health care contacts

    7. Alterations in medication during the visit [Alterations in medication during the ED visit and during the follow-up period, censored at 90 days]

      Alterations in medication during the ED visit and during the follow-up period(based on codes for Anatomical, Therapeutic, Chemical classification (ATC-code)

    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 questions to estimate frailty

    • or have a proxy to answer questions

    Exclusion Criteria:
    • <65 years

    • unable to answer questions to estimate frailty

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Linköping Linköping Östergötland Sweden 58185
    2 Medicinska Specialist Kliniken i Motala Motala Östergötland Sweden
    3 Vrinnevisjukhuset i Norrköping Norrköping Östergötland Sweden

    Sponsors and Collaborators

    • University Hospital, Linkoeping

    Investigators

    • Principal Investigator: Daniel Wilhelms, PhD, Linkoeping University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Daniel Wilhelms, Principal Investigator, University Hospital, Linkoeping
    ClinicalTrials.gov Identifier:
    NCT04888884
    Other Study ID Numbers:
    • 2021-00875LOI
    First Posted:
    May 17, 2021
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 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 May 4, 2022