- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Östergötland
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Linköping, Östergötland, Svezia, 58185
- University Hospital Linköping
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Motala, Östergötland, Svezia
- Medicinska Specialist Kliniken i Motala
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Norrköping, Östergötland, Svezia
- Vrinnevisjukhuset i Norrköping
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mortality in 30 Days
Lasso di tempo: All cause mortality up to 30 days from index visit
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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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mortalità a 7 e 90 giorni
Lasso di tempo: Mortalità per tutte le cause fino a 90 giorni dalla visita indice
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Indagare il livello di mortalità nella coorte a 7 e 90 giorni
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Mortalità per tutte le cause fino a 90 giorni dalla visita indice
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Ricovero in ospedale
Lasso di tempo: Ricovero in ospedale su visita indice, censurato a 90 giorni
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Indagare il livello di ricoveri per tutte le cause nella coorte
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Ricovero in ospedale su visita indice, censurato a 90 giorni
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ED durata del soggiorno
Lasso di tempo: Durata della permanenza in ED, censurata a 4 giorni
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Indagare sulla durata del soggiorno presso l'ED
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Durata della permanenza in ED, censurata a 4 giorni
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In-hospital length of stay
Lasso di tempo: 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
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Revisits to the ED
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Date di iscrizione allo studio
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2021-00875LOI
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