Emergency Medicine Evaluation for Acute Abdominal Pain - a Pragmatic Randomized Trial

This is a single-center, pragmatic, individually randomized, open-label, controlled clinical trial conducted in the emergency department at Haukeland University Hospital, Bergen, Norway. The study evaluates an alternative model for the initial assessment and management of adult patients presenting with undifferentiated acute abdominal conditions who are referred for gastrointestinal surgical assessment.

In current practice, these patients are usually initially assessed by a junior physician working in the surgical service. Diagnostic evaluation and treatment are subsequently discussed with more experienced surgical physicians as needed. This model may require several sequential assessments and may contribute to prolonged emergency department length of stay.

Emergency medicine was established as a medical specialty in Norway in 2019. Physicians specializing in emergency medicine are trained to assess a broad range of undifferentiated acute conditions, initiate diagnostic investigations and treatment, determine the appropriate level of care, and coordinate involvement of other specialties. However, there is limited evidence from Norwegian emergency departments regarding how the use of experienced emergency medicine physicians for the initial management of patients traditionally referred directly to surgical specialties affects patient flow, resource use, and safety.

The study therefore compares two models of initial care. In the intervention group, an experienced physician from the Department of Emergency Medicine, either a senior resident or consultant in emergency medicine, has primary responsibility for the initial assessment and management of the patient in the emergency department. This includes clinical assessment, selection and prioritization of laboratory and imaging investigations, initiation of treatment, and decisions regarding further disposition. Gastrointestinal surgeons or other relevant specialists are involved whenever clinically indicated.

In the control group, patients receive usual care according to the existing surgical admission pathway. The first medical assessment is usually performed by a junior physician working in the surgical service, with involvement of more experienced surgical physicians according to standard clinical routines.

The intervention does not introduce experimental diagnostic tests, medications, devices, or invasive procedures. Diagnostic investigations and treatment in both groups are performed according to usual clinical practice and applicable local and national guidelines. The difference between the study groups is primarily which physician group has responsibility for the initial assessment and coordination of care.

Participants are randomized in a 1:1 ratio using an electronic randomization system. Variable block sizes are used to maintain balance while limiting predictability of allocation. Because of the nature of the intervention, treating physicians and participants cannot be blinded to treatment allocation. Key study data are obtained from routinely collected electronic health record information where possible. Assessment of diagnostic agreement is planned to be performed by reviewers who are blinded to treatment allocation.

The primary analysis will follow the intention-to-treat principle. Participants will therefore be analyzed according to their assigned group regardless of subsequent changes in clinical responsibility or whether the final diagnosis is gastrointestinal surgical. Crossovers between the two models of care will be recorded, and a per-protocol analysis is planned as a sensitivity analysis.

The study is designed as a pragmatic evaluation of a change in the organization of emergency care. It is intended to determine whether assigning experienced emergency medicine physicians to the initial management of this patient population can improve emergency department efficiency while maintaining patient safety and appropriate use of diagnostic and therapeutic resources.

Because the intervention concerns organization of routine clinical care rather than an experimental treatment, the study is considered to involve low additional risk. Safety is monitored throughout the study. An independent Data Monitoring Committee reviews predefined safety information and may recommend continuation of the study, modification of study procedures or safety measures, temporary suspension of recruitment, or termination of the study if clinically important safety concerns arise. A planned interim safety review will be conducted after approximately 200 participants have been enrolled. Serious unexpected patient harm that may be related to the model of care will be reviewed independently irrespective of the timing of the planned safety review.

Inclusion criteria

• • 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.

Exclusion criteria

• • 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
• Open return access to the gastrointestinal surgery department (for example, known malignancy)
• Admission for a clearly defined postoperative complication following recent surgery