Emergency Medicine Evaluation for Acute Abdominal Pain - a Pragmatic Randomized Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaukeland University Hospital
About this trial
The goal of this clinical trial is to learn whether initial assessment by a physician specializing in emergency medicine can improve the care of adults who come to the emergency department with acute abdominal pain or another undifferentiated acute abdominal condition and are referred for surgical assessment.
The main questions it aims to answer are:
Does initial assessment by an emergency medicine physician reduce the time patients spend in the emergency department? Is this model of care as safe as standard surgical assessment, including the risk of readmission and death within 30 days?
Researchers will compare patients who receive their initial assessment from an experienced emergency medicine physician with patients who receive standard care, where the initial assessment is usually performed by a junior surgical physician.
Participants will:
Be randomly assigned to one of the two models of initial assessment Receive diagnostic tests and treatment according to usual clinical practice Be followed for outcomes such as use of diagnostic imaging, treatment, hospital stay, readmission, and mortality Be asked to complete a short questionnaire about their experience in the emergency department
The study does not involve experimental drugs, devices, or procedures. The intervention changes which type of physician is responsible for the initial assessment and management in the emergency department.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Age ≥18 years
Referred to or arrived at the emergency department at Haukeland University Hospital and referred for gastrointestinal surgical assessment on arrival
Presenting with undifferentiated acute abdominal pain or another acute abdominal problem for which the final diagnosis and level of treatment have not been clarified on arrival
Has capacity to consent and provides informed consent If a patient is initially referred to another specialty but, after primary triage/initial assessment, is reclassified as having a gastrointestinal surgical problem before the first physician contact, the patient may be included if the other criteria are fulfilled.
Disqualifiers
• Age <18 years
Does not have capacity to consent
Previously included in the study
Known and clarified surgical diagnosis with an established treatment plan on arrival
Trial design
Design model
Parallel
Treatments tested in this trial
Emergency Medicine Initial Assessment
Other interventionInitial assessment and management in the emergency department by an experienced emergency medicine physician (senior resident or consultant in emergency medicine), including clinical assessment, selection and prioritization of diagnostic investigations, initiation of treatment, and decisions regarding further disposition. Surgical or other specialist input is obtained when clinically indicated.
Standard Surgical Assessment
Other interventionStandard care according to the existing surgical admission pathway. The initial medical assessment will usually be performed by a junior physician working in the surgical service, with diagnostic evaluation and treatment conducted according to usual clinical practice. More experienced surgical physicians will be involved according to standard routines and clinical need.
Treatment groups
440 Participants
are divided into 2 treatment groupsGroup A: Emergency Medicine Initial AssessmentExperimental treatment 1 intervention
Group B: Standard Surgical AssessmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Emergency Department Length of Stay
Emergency department length of stay, measured in minutes from the participant's registered arrival at the emergency department to registered departure from the emergency department. Departure is defined as transfer to an inpatient ward, operating room, or another department, or discharge directly from the emergency department. For participants who die in the emergency department, the time of death will be used as the departure time. Times will be obtained from electronic timestamps in the hospital electronic health record.
Time frame
From registered arrival at the emergency department until departure from the emergency department, assessed up to 48 hours.Secondary outcomes
1
Tentative Diagnosis Documented
Proportion of participants with a tentative diagnosis documented in the admission note.
Time frame
Within 48 hours of emergency department arrival.2
Diagnostic Agreement
Agreement between the tentative diagnosis documented and validated in the admission note within 48 hours of emergency department arrival and the final principal discharge diagnosis from the index hospitalization.
Time frame
From emergency department arrival until discharge from the index hospitalization, assessed up to 30 days after arrival.3
Use of Computed Tomography
Proportion of participants undergoing computed tomography during the first hospital day.
Time frame
Within the first 24 hours of the index hospitalization4
Use of Ultrasound
Proportion of participants undergoing ultrasound performed by the radiology department during the first hospital day.
Time frame
Within the first 24 hours of the index hospitalizationOther outcomes
1
Patient Experience Score
Mean score from Likert-scale questions assessing communication and involvement during the emergency department stay. Higher scores indicate a better patient experience.
Time frame
Assessed at emergency department departure or within 48 hours after departure.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: