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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.


Recruitment information / eligibility

Status Completed
Enrollment 583
Est. completion date August 30, 2022
Est. primary completion date April 24, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients of 18 years and older - Patient is treated at ED during inclusion period - Patient is able and willing to sign informed consent or has a legal representative Exclusion Criteria: - Language barrier

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Zuyderland MC Heerlen
Netherlands MUMC Maastricht Limburg
Netherlands Laurentius Ziekenhuis Roermond Roermond
Netherlands Zuyderland MC Sittard
Netherlands VieCuri Venlo
Netherlands St. Jans Gasthuis Weert Weert

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total time a patient spent in acute care chain. Patient journey in the acute care chain. From all included patients: We measure the duration in the Acute care chain: From the moment a patient has contact with the referring healthcare provider until ED discharge up to hours with a maximum of 48 hours.Time unit: hours.
Secondary Number of contacts with a healthcare provider this disease period Did patients have contact with care provider(s) before visiting the ED? If yes, which type of care providers were they and what was the urgency level? We ask the included patients during the inclusion periode how many healthcare providers the contacted: From first contact with a healthcare provider this disease period until entering the ED. This disease period = start complaints Days, maximum 14 days. Time unit: days.
Secondary How many investigations were done during the ED visit Which investigations are carried out: blood test, ultrasound, x-ray? Patients that present in the inclusion period, at the ED. During the ED visit of the patient we look at the amount and which ancillary investigations are done. Timeframe = ED stay. No change is measured. During ED stay, that means in a couple of hours. ED stays are no longer that > 1 day. time unit is hours.
Secondary Number of participant that are admitted to the hospital. What happens after ED visit? How many patients will be admitted. 30 days after ED visit we check on how many patients are admitted. Time frame 30 days. Unit: number of participants.
Secondary Number of participant that are deceased after 30 days. . What happens after ED visit? How many patients died 30 days after ED visit we check on how many patients are deceased. Time frame 30 days. Unit: number of participants.
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