Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05400707 |
| Other study ID # |
PB_2016-02667; am22Bingisser |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2024 |
| Est. completion date |
May 27, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
University Hospital, Basel, Switzerland |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is to evaluate a tool capable of improved risk prediction regarding the 30-day
mortality. The primary objective of this study is hospitalization, ICU-admission, morbidity
and mortality in correlation with external validation of International Early Warning Score
(IEWS) and decision-making processes regarding diagnosis, treatment and disposition in the
ED.
Description:
Most emergency departments (EDs) perform an initial risk stratification of patients, called
triage. Triage defines the process of systematically grouping patients according to their
treatment priority on the base of algorithms in an environment with scarce health care
resources. To this date no gold standard in triage risk stratification has been established.
Most of the existing triage systems rely on the measurement of vital signs and a list of
chief complaints. All of these systems have their shortcomings, especially in nonspecific ED
presentations and in older patients. The primary objective of this study is hospitalization,
ICU-admission, morbidity and mortality in correlation with external validation of
International Early Warning Score (IEWS) and decision-making processes regarding diagnosis,
treatment and disposition in the ED.
In this national single centre, prospective, consecutive, observational all-comers study
patients entering the ED undergo triage and will be verbally informed about the study. First,
each patient's vital signs (respiratory rate, oxygen saturation, heart rate, blood pressure,
temperature) are measured and pain is rated on a scale of 0 to 10. In addition, the patient's
level of consciousness is assessed using the AVPUC scale (alert, new confusion, verbal, pain,
unresponsive, new confusion). Patients are asked to rate their own mobility between stable
walking without aids or limited mobility with aids (walking aid, wheelchair, lying down). In
addition, the patient's mobility is observed by the triage staff. The probability that the
patient will be admitted as an inpatient is then assessed. A Clinical Frailty Scale (CFS) is
also completed for patients over 65. After triage, patients are transferred to the treatment
unit. Patients in need of immediate therapy, such as analgesia, will receive therapy before
start of the interview. Patients will then be approached by a member of the study personnel
and will be asked "which symptoms are you experiencing at the moment?". The question will be
repeated 3 times, Answers will be recorded by ticking boxes in the CRF for a predefined list
of 37 symptoms. Then, patients will be asked "which of the symptoms you reported is most
important to you?". Patients are asked for their opinion on whether they should be discharged
home after emergency treatment or whether they should stay in the hospital. Patients over the
age of 65 are asked the following: "generally asked: what matters most to you at the moment?"
and "why is that important for you?".
Then, the attending senior physicians are asked how injured/ill they rate the patients on a
scale from 0 (not ill/injured) to 10 (very ill/injured). The senior physicians are asked
questions about decision-making in the emergency department. With regard to diagnostics, they
are asked what type of diagnostic decision is involved (simple or complex decision), whether
there was time pressure when making the diagnostic decision and which factors formed the
basis for their diagnostic decision (list of 14 factors, numbered according to importance if
applicable). Regarding therapy, respondents were also asked what type of therapeutic decision
was involved (simple or complex decision), whether there was time pressure in making the
therapeutic decision, and which factors formed the basis for their therapeutic decision (list
of 14 factors, numbered according to importance if applicable). Then the disposition of the
patient (ambulatory or hospitalized) is defined. For ambulant patients, senior physicians are
asked which factors formed the basis for their ambulant disposition (list of 9 factors,
numbered according to importance if applicable). For hospitalized patients, the senior
physicians are asked which factors were the basis for their inpatient disposition (list of 17
factors, numbered according to importance if applicable). Finally, the attending physicians
are asked who made the disposition decision.
Follow-up to assess 30-day and 1-year mortality rate and date of death will start one year
after the end of the inclusion period.
