- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Östergötland
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Linköping, Östergötland, 스웨덴, 58185
- University Hospital Linköping
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Motala, Östergötland, 스웨덴
- Medicinska Specialist Kliniken i Motala
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Norrköping, Östergötland, 스웨덴
- Vrinnevisjukhuset i Norrköping
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mortality in 30 Days
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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7일 및 90일의 사망률
기간: 색인 방문으로부터 최대 90일까지 모든 원인으로 인한 사망
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7일 및 90일에 코호트에서 사망률 수준 조사
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색인 방문으로부터 최대 90일까지 모든 원인으로 인한 사망
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입원
기간: 색인 방문 시 병원 입원, 90일에 검열
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코호트에서 모든 원인 입원 수준 조사
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색인 방문 시 병원 입원, 90일에 검열
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ED 체류 기간
기간: ED에서의 체류 기간, 4일에서 검열됨
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ED 체류 기간 조사
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ED에서의 체류 기간, 4일에서 검열됨
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In-hospital length of stay
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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