- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04888884
Loss of Independence - a Rapid Alternative to Frailty Screening in a Swedish ED Setting
Loss of Independence (LOI) - a Rapid Alternative to Frailty Screening in a Swedish Emergency Department 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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Östergötland
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Linköping, Östergötland, Sverige, 58185
- University Hospital Linköping
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Motala, Östergötland, Sverige
- Medicinska Specialist Kliniken i Motala
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Norrköping, Östergötland, Sverige
- Vrinnevisjukhuset i Norrköping
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mortality in 30 Days
Tidsramme: All cause mortality up to 30 days from index visit
|
Investigate level of mortality in cohort at 30 days
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All cause mortality up to 30 days from index visit
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Dødelighet på 7 og 90 dager
Tidsramme: Alle forårsaker dødelighet opptil 90 dager fra indeksbesøk
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Undersøke nivå av dødelighet i kohort ved 7 og 90 dager
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Alle forårsaker dødelighet opptil 90 dager fra indeksbesøk
|
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Innleggelse på sykehus
Tidsramme: Sykehusinnleggelse på indeksbesøk, sensurert ved 90 dager
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Undersøk nivået på alle årsaksinnleggelser i kohort
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Sykehusinnleggelse på indeksbesøk, sensurert ved 90 dager
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ED liggetid
Tidsramme: Varighet på opphold på ED, sensurert til 4 dager
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Undersøk lengden på oppholdet på ED
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Varighet på opphold på ED, sensurert til 4 dager
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|
In-hospital length of stay
Tidsramme: In-hospital length of stay from index visit, censored at 90 days
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Investigate in-hospital length of stay
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In-hospital length of stay from index visit, censored at 90 days
|
|
Revisits to the ED
Tidsramme: Number of newly registered visits to the ED after index visit, censored at 90 days
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Number of newly registered visits to the ED after index visit
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Number of newly registered visits to the ED after index visit, censored at 90 days
|
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Fall prevalence after index visit
Tidsramme: Falls that resulted in further health care contacts after index visit, censored at 90 days
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Falls that resulted in further health care contacts
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Falls that resulted in further health care contacts after index visit, censored at 90 days
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Alterations in medication during the visit
Tidsramme: Alterations in medication during the ED visit and during the follow-up period, censored at 90 days
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Alterations in medication during the ED visit and during the follow-up period(based on codes for Anatomical, Therapeutic, Chemical classification (ATC-code)
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Alterations in medication during the ED visit and during the follow-up period, censored at 90 days
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Kellett J, Deane B. The Simple Clinical Score predicts mortality for 30 days after admission to an acute medical unit. QJM. 2006 Nov;99(11):771-81. doi: 10.1093/qjmed/hcl112. Epub 2006 Oct 17.
- Kellett J, Deane B, Gleeson M. Derivation and validation of a score based on Hypotension, Oxygen saturation, low Temperature, ECG changes and Loss of independence (HOTEL) that predicts early mortality between 15 min and 24 h after admission to an acute medical unit. Resuscitation. 2008 Jul;78(1):52-8. doi: 10.1016/j.resuscitation.2008.02.011. Epub 2008 Apr 10.
- Brabrand M, Folkestad L, Clausen NG, Knudsen T, Hallas J. Risk scoring systems for adults admitted to the emergency department: a systematic review. Scand J Trauma Resusc Emerg Med. 2010 Feb 11;18:8. doi: 10.1186/1757-7241-18-8.
- Brabrand M, Lassen AT, Knudsen T, Hallas J. Seven-day mortality can be predicted in medical patients by blood pressure, age, respiratory rate, loss of independence, and peripheral oxygen saturation (the PARIS score): a prospective cohort study with external validation. PLoS One. 2015 Apr 13;10(4):e0122480. doi: 10.1371/journal.pone.0122480. eCollection 2015.
- Rylance J, Baker T, Mushi E, Mashaga D. Use of an early warning score and ability to walk predicts mortality in medical patients admitted to hospitals in Tanzania. Trans R Soc Trop Med Hyg. 2009 Aug;103(8):790-4. doi: 10.1016/j.trstmh.2009.05.004. Epub 2009 Jun 21.
- Berian JR, Mohanty S, Ko CY, Rosenthal RA, Robinson TN. Association of Loss of Independence With Readmission and Death After Discharge in Older Patients After Surgical Procedures. JAMA Surg. 2016 Sep 21;151(9):e161689. doi: 10.1001/jamasurg.2016.1689. Epub 2016 Sep 21.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2021-00875LOI
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