- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Descrição detalhada
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 de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Östergötland
-
Linköping, Östergötland, Suécia, 58185
- University Hospital Linköping
-
Motala, Östergötland, Suécia
- Medicinska Specialist Kliniken i Motala
-
Norrköping, Östergötland, Suécia
- Vrinnevisjukhuset i Norrköping
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mortality in 30 Days
Prazo: All cause mortality up to 30 days from index visit
|
Investigate level of mortality in cohort at 30 days
|
All cause mortality up to 30 days from index visit
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mortalidade em 7 e 90 dias
Prazo: Todas as causas de mortalidade até 90 dias a partir da visita inicial
|
Investigar o nível de mortalidade na coorte aos 7 e 90 dias
|
Todas as causas de mortalidade até 90 dias a partir da visita inicial
|
|
Admissão no hospital
Prazo: Admissão hospitalar na visita inicial, censurada aos 90 dias
|
Investigar o nível de internações por todas as causas na coorte
|
Admissão hospitalar na visita inicial, censurada aos 90 dias
|
|
Duração da estadia no ED
Prazo: Tempo de permanência no ED, censurado em 4 dias
|
Investigar o tempo de permanência no ED
|
Tempo de permanência no ED, censurado em 4 dias
|
|
In-hospital length of stay
Prazo: In-hospital length of stay from index visit, censored at 90 days
|
Investigate in-hospital length of stay
|
In-hospital length of stay from index visit, censored at 90 days
|
|
Revisits to the ED
Prazo: 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
|
Number of newly registered visits to the ED after index visit, censored at 90 days
|
|
Fall prevalence after index visit
Prazo: Falls that resulted in further health care contacts after index visit, censored at 90 days
|
Falls that resulted in further health care contacts
|
Falls that resulted in further health care contacts after index visit, censored at 90 days
|
|
Alterations in medication during the visit
Prazo: 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)
|
Alterations in medication during the ED visit and during the follow-up period, censored at 90 days
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2021-00875LOI
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .