Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06079099 |
Other study ID # |
TACC |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 20, 2022 |
Est. completion date |
August 30, 2022 |
Study information
Verified date |
December 2021 |
Source |
Maastricht University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This study is part of a research domain focusing on the acute care chain, which includes the
patient journey from symptoms to treatment on the Emergency Medical Department (ED). Within
hospitals there is much attention for triage and the amount of time patients spent within the
chain, especially for the ED. However, there is less information available on what occurs
before patients visit the ED. Gaining more insight in the patient journey in the acute care
chain as a whole, might provide important information to further optimize care at the ED. In
the current study, 750 patients will be included at multiple ED's in the Netherlands. The
primary goal is to gain insight in the patient journey of adult ED patients.
Description:
All adult ED patients in the province of Limburg will be included in a 72 hour time frame.
Students were present at the EDs 24 hours to include all these patients. Patient data were
gathered from medical records (including hospital file, referral letters and EMS notes) using
a Case Report Form (CRF) and from a questionnaire filled out by the patient. Data were
collected on demographic variables, including sex, age, highest level of education, living
situation and the presence of roommates. Furthermore, information regarding the ACC and Time
spent in the ACC (TACC) was collected.
The entire ACC was divided into four phases: the pre-referral phase, the referral phase, the
ED phase and the post ED phase. In each phase several variables were collected.
Pre-referral phase The pre-referral phase started with the onset of complaints this disease
period up to the referring contact. The following variables of this phase were collected: the
symptom duration in days calculated from the day of onset of symptoms until ED visit, number
of prior contacts with a healthcare provider and prescribed medication this disease period
before ED visit. A prior contact with a healthcare provider was defined as a contact within
this disease period, regarding the same complaint, and before the contact during which the
patient was referred to the ED.
Referral phase The referral phase started with the moment of referral until arrival at the
ED. The following variables of this phase were collected: time and date of referral contact,
referring health care provider (GP, EMS, medical specialist, nursing home doctor, other or
self-referral), prehospital triage urgency (EMS and GCP), and mode of transportation to the
ED (own transport or by EMS). Prehospital triage urgency levels (for GPC and EMS) are
determined using the Netherlands Triage Standard (NTS), which categorizes patients from U1
(life threatening, immediate action required) up to U5 (advice, a physical examination can
wait until the next day) (16). If necessary, an ambulance is subsequently dispatched
according to these urgency levels.
ED phase The ED phase started with arrival at the ED until hospital discharge, including
30-day follow-up. The following variables of this phase were collected at the ED: referred
specialty (the specialty to which the patient has been referred), treating specialty (the
specialty that eventually treated/discharged/admitted the patient), triage urgency level (MTS
(17)), presenting symptoms, the number of patients with a presumptive prespecified complex
condition, ED work up, and arrival and departure time in the ED to calculate the length of
stay (LOS).
The EDs in this study use the Manchester Triage System (MTS) as a triage system, which
categorises patients into five levels of urgency (17). Immediate (red) patients are to be
evaluated immediately, whereas non-urgent (blue) patients are allowed to wait for 240 minutes
prior to evaluation. In this study we combined red and orange triage urgencies as 'highly
urgent' (evaluation within 10 minutes maximum), and yellow, green and blue as 'urgent'
(evaluation within 60-240 minutes). Presenting symptoms were categorized into 18 groups after
discussion with the researchers: minor trauma, abdominal pain, dyspnoea, general malaise,
fever, extremity complaints (e.g. arthritis), neurological complaints, syncope/palpitations,
skin symptoms, urological complaints, complaints after treatment, allergic reaction,
hypertension, minor oncological complaints (e.g. rash), chest pain, ENT problem,
intoxication, and other. Prespecified complex conditions were defined as patients presenting
with the presumptive diagnosis of a stroke, myocardial infarction, aortic syndrome or major
trauma.
The ED work up was defined as simple when ED work-up included lab tests, electrocardiogram
and X-ray and was defined complex when included CT, ultrasound, lumbar puncture (LP),
abdominal paracentesis, gastroscopy, MRI scan and consultations of other specialties.
Post ED phase The post ED phase started after ED discharge until 30-day follow-up. The
following variables were collected: post-ED disposition, 7- and 30-day all-cause mortality
and 30-day revisit. A combination of 7- and 30-day all-cause mortality and 30-day revisit
were called adverse outcome.