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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01768494
Other study ID # TRIAGE-1
Secondary ID
Status Completed
Phase N/A
First received January 9, 2013
Last updated December 11, 2014
Start date March 2013
Est. completion date October 2014

Study information

Verified date December 2014
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

Patients presenting to the emergency department (ED) currently face inacceptable delays in initial treatment, and long and costly hospital stays due to suboptimal initial triage. Accurate ED triage should focus not only on initial treatment priority, but also on prediction of medical risk and nursing needs to improve site of care decision and to simplify early discharge management. Herein, we propose a large prospective cohort study to optimize initial patient triage for (a) better determination of initial treatment priority, (b) overall risk and need for inhospital treatment and (c) early assessment of post-acute nursing needs.


Description:

Background: Patients presenting to the emergency department (ED) currently face inacceptable delays in initial treatment, and long and costly hospital stays due to suboptimal initial triage. Accurate ED triage should focus not only on initial treatment priority, but also on prediction of medical risk and nursing needs to improve site of care decision and to simplify early discharge management. Different triage scores have been proposed, such as the Manchester Triage Score (MTS). Yet, these scores focus only on treatment priority, have suboptimal performance and lack validation in the Swiss Health care system. Because the MTS will be introduced into clinical routine of the Kantonsspital Aarau, we propose a large prospective cohort study to optimize initial patient triage. Specifically, the aim of this trial is to derive a three part triage algorithm to better predict (a) treatment priority; (b) medical risk and thus need for inhospital treatment; (c) post-acute care needs of patient's at the most proximal time point of ED admission.

Methods / Design: Prospective, observational, cohort study. We will include all consecutive medical patients seeking ED care into this observational registry. There will be no exclusions except for non-adult and non-medical patients. Vital signs will be recorded and left over blood samples will be stored for later batch analysis of blood markers. Upon ED discharge, the post-acute care score will be recorded. Attending ED physicians will adjudicate triage priority based on all available results at the time of discharge. Patients will be reassessed daily during the hospital course for medical and nursing stability. To assess outcomes, data from electronic medical records will be used and all patient will be contacted 30 days after hospital admission to assess vital status, rehospitalisation and quality of life measures.

We aim to include between 5000 and 7000 patients over one year of recruitment to derive the three part triage algorithm. The respective main endpoints were defined as (a) initial triage priority (high vs. low priority) adjudicated by the attending ED physician at ED discharge, (b) adverse 30 day outcome (death or intensive care unit admission) within 30 days following ED admission to assess patients risk and thus need for inhospital treatment and (c) care needs after hospital discharge, defined as transfer of patients to a post-acute care institution, for early recognition and planning of post-acute care needs. Other outcomes are time to first physician contact, time to initiation of adequate medical therapy, length of hospital stay, patient's satisfaction with care and overall hospital costs.

Discussion: Using a reliable initial triage system for estimating initial treatment priority, need for inhospital treatment and post-acute care needs is an innovative and persuasive approach for a more targeted management of medical patients in the ED. Our group has proven feasibility with a track record of several completed and ongoing trials. The proposed interdisciplinary project has unprecedented potential to improve initial triage decisions and optimize resource allocation to the sickest patients from admission to discharge. The algorithms derived in this study will be compared in a later randomized controlled trial against a usual care control group in terms of resource use, length of hospital stay, overall costs and patient's outcomes in terms of mortality, rehospitalisation, quality of life and satisfaction with care.


Recruitment information / eligibility

Status Completed
Enrollment 7000
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All consecutive medical patients seeking ED care

Exclusion Criteria:

- age below 18 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland University Clinic, Kantonsspital Aarau Aarau AG

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Initial triage priority Initial triage priority adjudicated by the attending ED physician. Attending ED physicians will classify all patients at ED discharge as either high triage priority or low triage priority in respect to the time patients need to be seen by a physician based on all available information at ED discharge within 30 days No
Primary Adverse 30 day outcome (death or intensive care unit admission) within 30 days following ED admission Adverse 30 day outcome (death or intensive care unit admission) within the hospital stay and within 30 days following ED admission Within 30 days of ED admission No
Primary Care needs after hospital discharge Care needs after hospital discharge will be defined as transfer of patients to a post-acute care institution (i.e. transition to a nursing home and others). Within 30 days No
Secondary Time to first physician contact Time to first physician contact as assessed in the nursing chart; we will investigate this endpoint stratified by patient risk, i.e. we will compare time to first physician contact in high-triage-priority and low-triage-priority patients and stratified by different diagnoses. Within 30 days No
Secondary Time to initiation of adequate medical therapy Time to initiation of adequate medical therapy in predefined subgroups (e.g., antibiotic therapy for infections, door to needle time for myocardial infarction; early goal directed therapy in sepsis patients, pain relief medication in patients presenting with pain, blood pressure control in patients with a hypertensive crisis); we will further assess time to discharge from the ED to the ward. Wihtin 30 days No
Secondary Satisfaction with care Satisfaction with care as assessed with a systematic questionnaire in the day 30 telephone interview Within 30 days No
Secondary Hospital costs Overall hospital costs as assessed by the electronic medical records Within 30 days No
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