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)

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). Electronic supplementary material The online version of this article (10.1186/s12877-019-1078-2) contains supplementary material, which is available to authorized users.

Value of biomarkers in predicting mortality in older medical emergency department patients: a Dutch prospective study

“…We detected no evidence for selection bias but cannot exclude it either. 17 In addition, we only measured biomarker values immediately after arrival at the ED. It is possible that serial biomarker measurement may have yielded different information and a different predictive ability.…”

“…The study protocol of this study was published online. 17 This part of the study took place in Zuyderland Medical Centre (MC), a large teaching hospital in the south of the Netherlands, because biomarkers were measured in patients included in this site only. Patients were included if they visited the ED between July 2016 and February 2017, were 65 years old or older, were examined and treated by an internist or gastroenterologist and provided written informed consent.…”

“…The sample size available for this study depended on a prospective cohort study, the RISE UP Study, which provided data on 450 patients. 17 For logistic regression analysis, at least 10 event per candidate predictor are needed, according to prediction modelling guidelines. We assumed that the mortality rate would be around 11%.…”

Concerns of older patients and their caregivers in the emergency department

“…Older ED patients (�65 years) treated by internists or gastroenterologists were eligible for inclusion after informed consent was obtained from the patient or legal representative. The study protocol was approved by the medical ethics committees of Zuyderland MC and MUMC+ (NL55867.096.15) and published online [11]. This study was reported in line with the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) guidelines [13].…”

“…Since many patients feel inhibited to talk about their feelings to the ED staff [8,10], it is likely that their concerns have not been completely exposed in these studies. Recently, we performed the RISE UP study to find predictors of adverse outcomes in older ED patients [11], and found that the severity of concerns in patients and caregivers is predictive of adverse outcomes [12]. It may, therefore, also be possible that specific concerns are predictive of that particular outcome.…”