Risk Stratification in the Emergency Department in Acutely Ill Older Patients

Elderly Patiënts Clinical Trial

— RiSEuP  

Official title:

Risk Stratification in Elderly Patients in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946398
• Other study ID #: NL55867.096.15
• Status: Completed
• Start date: July 14, 2016
• Est. completion date: July 6, 2019

Study information

• Verified date: July 2019
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Procedures for identification of high-risk elderly patients in the emergency department are lacking.

We aim to identify early risk factors associated with an adverse outcome in elderly patients who visit the emergency department (ED). Second, we aim to find practical tools to identify those elderly patients who are at risk for an adverse outcome in an early stage (by applying and testing triage and risk stratification scores, clinical impression and laboratory results).

With the results of this study, we intend to develop a clinical prediction model to identify older emergency department patients with an increased risk of adverse outcomes.

Description:

Background:

Elderly patients (≥65 years of age) constitute an increasing population in emergency departments (EDs) in many countries. These patients are largely different from younger patients and undoubtedly need different approaches in acute care. Commonly used triage systems are not validated in elderly patients. We hypothesize that this factor contributes to a lack of recognition of patients at risk for adverse events or death.

Aim of the study:

• At first, we will try to identify early risk factors associated with adverse outcome such as age, the premorbid state (comorbidity, living status and cognitive/functional state), medication use, vital signs, and number of previous visits to the ED.

• Secondly, we will investigate the discriminating power of several triage and risk stratification scores. In our study, we will retrieve and validate the following triage and risk stratification scores: The Manchester Triage System (MTS) triage score, the Acute Physiology and Chronic Health Evaluation II (APACHE II) score and the Identification of Seniors At Risk-Hospitalised Patients (ISAR-HP) score for all hospitalized patients. Furthermore, we will calculate four well-known disease specific stratification scores: The Glasgow-Blatchford Bleeding (GBS Score) for patients with an upper gastrointestinal bleeding, the Abbreviated Mortality ED Sepsis (abbMEDS) score and Sepsis-related Organ Failure Assessment (SOFA) score and the Confusion, Urea, Respiration, Blood pressure, Age >65 years (CURB-65) score.

• Thirdly, we will investigate the predictive value of the clinical impression of professionals (doctor/nurse) and the disease perception of patient/companion.

• Fourth, we will investigate the predictive value of laboratory tests (routine tests and biomarkers like lactate, N-terminal pro-B-type natriuretic peptide (NT-pro-BNP), high-sensitivity troponin (hs-TnT), procalcitonin (PCT) and d-dimer.

• At last, we intend to develop a clinical prediction model for short-term mortality and test the predictive ability of this model for the other adverse outcomes/endpoints. This model will be validated in an external cohort.

Study procedure:

The design is a multi-center prospective observational cohort study. The study will take place in Zuyderland MC in Heerlen and Maastricht UMC+ in the Netherlands. On presentation to the ED the patients will be given information about the study and informed consent will be signed. The patient or family member/companion, the nurse and the doctor will be asked to fill out a questionnaire in the ED (5 questions for patient/family and 9 questions for doctor or nurse). These questions will be used for evaluation of the clinical impression of the doctor/nurse and disease perception by the patient/companion. At the ED, 2 extra venous samples and one arterial blood gas sample will be taken in patients participating in the study in Zuyderland M.C. Blood gas analysis will take place immediately and the results will be presented to the attending doctor. Analysis of the biomarkers from the venous blood samples will take place after a few weeks and the results will be blinded in this study. Routine laboratory test will be analyzed in both hospitals. During the days and weeks after inclusion, data will be obtained from patients medical records. During the days and weeks after inclusion, data will be obtained from patients medical records. All patients will be followed up for 30 days and if possible for one year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 6, 2019
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age =65 years

• Visit to the emergency department for the internist/gastroenterologist

• Informed consent

Exclusion Criteria:

• Earlier participation in study (patients can only be included once)

• No informed consent

• Inability to speak Dutch or English

• Admission to a ward of another specialty than internal medicine/gastroenterology

Related Conditions & MeSH terms

• Elderly Patiënts
• Emergencies

Locations

Country	Name	City	State
Netherlands	Zuyderland Medisch Centrum	Heerlen	Limburg
Netherlands	Maastricht UMC+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day all cause mortality	all cause mortality within 30 days (both in- and out-hopsital)	30 days
Secondary	composite secondary outcome	Length of hospital stay longer than 1 week; ICU/MCU admission; all cause mortality within 30 days of presentation to the ED; Readmission within 30 days of discharge from the hospital; Discharge to another residence than previous address (nursing home/hospice)	30 days or 30 days after hospital discharge
Secondary	all cause mortality after 1 year	all cause mortality after 1 year	1 year