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Risk Stratification in the Emergency Department in Acutely Ill Older Patients (RiSEuP)

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ClinicalTrials.gov Identifier: NCT02946398
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Jacqueline Buijs, Zuyderland Medisch Centrum

Brief 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.


Condition or disease
Elderly Patiënts

Detailed 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.

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Stratification in Elderly Patients in the Emergency Department
Actual Study Start Date : July 14, 2016
Actual Primary Completion Date : May 2, 2017
Actual Study Completion Date : July 6, 2019

Group/Cohort
elderly patients who visit the ED
elderly patients (65 years and older) who present to the emergency department for internal medicine or gastroenterology



Primary Outcome Measures :
  1. 30-day all cause mortality [ Time Frame: 30 days ]
    all cause mortality within 30 days (both in- and out-hopsital)


Secondary Outcome Measures :
  1. composite secondary outcome [ Time Frame: 30 days or 30 days after hospital discharge ]
    1. Length of hospital stay longer than 1 week
    2. ICU/MCU admission
    3. all cause mortality within 30 days of presentation to the ED
    4. Readmission within 30 days of discharge from the hospital
    5. Discharge to another residence than previous address (nursing home/hospice)

  2. all cause mortality after 1 year [ Time Frame: 1 year ]
    all cause mortality after 1 year


Biospecimen Retention:   Samples Without DNA
Venous serum samples: 2. These samples will only be taken in patients who are enrolled in the study in Zuyderland MC (450 patients - anticipated).


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients ≥65 years of age who present to the ED for internal medicine or gastroenterology within the participating hospitals.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946398


Locations
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Netherlands
Zuyderland Medisch Centrum
Heerlen, Limburg, Netherlands, 6401 CX
Maastricht UMC+
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Zuyderland Medisch Centrum
Investigators
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Principal Investigator: Jacqueline Buijs, dr. Zuyderland M.C.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jacqueline Buijs, Internist, Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier: NCT02946398    
Other Study ID Numbers: NL55867.096.15
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes