Risk Stratification in the Emergency Department in Acutely Ill Older Patients

NCT ID: NCT02946398

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-14

Study Completion Date

2019-07-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elderly Patiënts

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

elderly patients who visit the ED

elderly patients (65 years and older) who present to the emergency department for internal medicine or gastroenterology

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zuyderland Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jacqueline Buijs

Internist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jacqueline Buijs, dr.

Role: PRINCIPAL_INVESTIGATOR

Zuyderland M.C.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zuyderland Medisch Centrum

Heerlen, Limburg, Netherlands

Site Status

Maastricht UMC+

Maastricht, Limburg, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

Zelis N, Hundscheid R, Buijs J, De Leeuw PW, Raijmakers MT, van Kuijk SM, Stassen PM. Value of biomarkers in predicting mortality in older medical emergency department patients: a Dutch prospective study. BMJ Open. 2021 Jan 31;11(1):e042989. doi: 10.1136/bmjopen-2020-042989.

Reference Type DERIVED
PMID: 33518523 (View on PubMed)

Zelis N, Huisman SE, Mauritz AN, Buijs J, de Leeuw PW, Stassen PM. Concerns of older patients and their caregivers in the emergency department. PLoS One. 2020 Jul 9;15(7):e0235708. doi: 10.1371/journal.pone.0235708. eCollection 2020.

Reference Type DERIVED
PMID: 32645113 (View on PubMed)

Zelis N, Buijs J, de Leeuw PW, van Kuijk SMJ, Stassen PM. Study protocol for a multicentre prospective cohort study to identify predictors of adverse outcome in older medical emergency department patients (the Risk Stratification in the Emergency Department in Acutely Ill Older Patients (RISE UP) study). BMC Geriatr. 2019 Mar 4;19(1):65. doi: 10.1186/s12877-019-1078-2.

Reference Type DERIVED
PMID: 30832571 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NL55867.096.15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.