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)

Noortje Zelis, Jacqueline Buijs, Peter W de Leeuw, Sander M J van Kuijk, Patricia M Stassen, Noortje Zelis, Jacqueline Buijs, Peter W de Leeuw, Sander M J van Kuijk, Patricia M Stassen

Abstract

Background: Older patients (≥65 years old) experience high rates of adverse outcomes after an emergency department (ED) visit. Reliable tools to predict adverse outcomes in this population are lacking. This manuscript comprises a study protocol for the Risk Stratification in the Emergency Department in Acutely Ill Older Patients (RISE UP) study that aims to identify predictors of adverse outcome (including triage- and risk stratification scores) and intends to design a feasible prediction model for older patients that can be used in the ED.

Methods: The RISE UP study is a prospective observational multicentre cohort study in older (≥65 years of age) ED patients treated by internists or gastroenterologists in Zuyderland Medical Centre and Maastricht University Medical Centre+ in the Netherlands. After obtaining informed consent, patients characteristics, vital signs, functional status and routine laboratory tests will be retrieved. In addition, disease perception questionnaires will be filled out by patients or their caregivers and clinical impression questionnaires by nurses and physicians. Moreover, both arterial and venous blood samples will be taken in order to determine additional biomarkers. The discriminatory value of triage- and risk stratification scores, clinical impression scores and laboratory tests will be evaluated. Univariable logistic regression will be used to identify predictors of adverse outcomes. With these data we intend to develop a clinical prediction model for 30-day mortality using multivariable logistic regression. This model will be validated in an external cohort. Our primary endpoint is 30-day all-cause mortality. The secondary (composite) endpoint consist of 30-day mortality, length of hospital stay, admission to intensive- or medium care units, readmission and loss of independent living. Patients will be followed up for at least 30 days and, if possible, for one year.

Discussion: In this study, we will retrieve a broad range of data concerning adverse outcomes in older patients visiting the ED with medical problems. We intend to develop a clinical tool for identification of older patients at risk of adverse outcomes that is feasible for use in the ED, in order to improve clinical decision making and medical care.

Trial registration: Retrospectively registered on clinicaltrials.gov ( NCT02946398 ; 9/20/2016).

Keywords: Emergency department; Older patients; Prognosis; Risk stratification.

Conflict of interest statement

Ethics approval and consent to participate

This study is approved by the medical ethics committee of Zuyderland MC, Heerlen, The Netherlands and MUMC+, Maastricht, the Netherlands (reference number NL55867.096.15). Patients or their legal representative have to sign an informed consent form before study entry. This study is in accordance to the 2013 version of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act (WMO). Risks for participating in this study are expected to be very small to negligible and all patients will receive standard care. Objection by an incapacitated patient will lead to exclusion from the study and analysis.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of study procedure

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