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NCT Number: NCT04888884

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

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.

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Key information

Conditions

Frailty Disease Attributes Emergencies Emergency Department Frailty Syndrome Geriatric Assessment Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Linköping, Linköping, Östergötland County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality in 30 Days

    Time frame: All cause mortality up to 30 days from index visit

    Investigate level of mortality in cohort at 30 days

Secondary outcomes

  1. Mortality in 7 and 90 days

    Time frame: 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

    Time frame: Hospital admission on index visit, censored at 90 days

    Investigate level of all cause admissions in cohort

  3. ED length of stay

    Time frame: Length of stay at ED, censored at 4 days

    Investigate length of stay at ED

  4. In-hospital length of stay

    Time frame: In-hospital length of stay from index visit, censored at 90 days

    Investigate in-hospital length of stay

  5. Revisits to the ED

    Time frame: 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

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

Loss of Independence (LOI) - a Rapid Alternative to Frailty Screening in a Swedish Emergency Department Setting

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 17, 2021
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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