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.

• Emergency Medicine Initial Assessment (Other): Initial 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): Standard 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.

Primary outcomes

• Emergency Department Length of Stay [From registered arrival at the emergency department until departure from the emergency department, assessed up to 48 hours.]: 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.

Secondary outcomes

• Tentative Diagnosis Documented [Within 48 hours of emergency department arrival.]: Proportion of participants with a tentative diagnosis documented in the admission note.
• Diagnostic Agreement [From emergency department arrival until discharge from the index hospitalization, assessed up to 30 days after arrival.]: 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.
• Use of Computed Tomography [Within the first 24 hours of the index hospitalization]: Proportion of participants undergoing computed tomography during the first hospital day.
• Use of Ultrasound [Within the first 24 hours of the index hospitalization]: Proportion of participants undergoing ultrasound performed by the radiology department during the first hospital day.
• Assessment by a More Experienced Surgical Physician [From emergency department arrival until departure from the emergency department, assessed up to 48 hours after arrival.]: Proportion of participants assessed in the emergency department by a senior surgical resident or surgical consultant in addition to the initial assessing physician as documented in the physisians note.
• Antibiotic Treatment [From emergency department arrival until discharge from the index hospitalization, assessed up to 30 days after arrival.]: Proportion of participants receiving systemic antibiotic treatment during the index hospitalization.
• Antibiotic Treatment Concordant With National Guidelines [From emergency department arrival until discharge from the index hospitalization, assessed up to 30 days after arrival.]: Among participants receiving antibiotics, the proportion receiving an antimicrobial agent consistent with applicable national treatment guidelines. Assessment concerns choice of antimicrobial agent and does not include dose.
• Invasive Abdominal Intervention [From emergency department arrival through 30 days after arrival.]: Proportion of participants undergoing at least one therapeutic invasive abdominal intervention, including surgery, image-guided intervention, or therapeutic endoscopic intervention such as ERCP related to the acute condition.
• Admission to a Gastrointestinal Surgical Ward [From emergency department arrival until departure from the emergency department, assessed up to 48 hours after arrival.]: Proportion of participants admitted from the emergency department to a gastrointestinal surgical inpatient ward.
• Non-Gastrointestinal Surgical Condition Admitted to a Gastrointestinal Surgical Ward [From emergency department arrival until discharge from the index hospitalization, assessed up to 30 days after arrival.]: Proportion of participants dispositioned from the emergency department to a gastrointestinal surgical inpatient ward who have a final principal diagnosis outside the gastrointestinal surgical specialty, receive predominantly non-surgical treatment, and do not undergo surgery during the index hospitalization.
• 30-Day Readmission [Within 30 days after discharge from the index hospitalization]: Proportion of participants with at least one unplanned acute hospital readmission within 30 days after discharge from the index hospitalization.
• 30-Day All-Cause Mortality [Within 30 days after ED presentation]: Proportion of participants who die from any cause within 30 days after Emergency Department presentation.
• Time From Emergency Department Arrival to Completion of Initial Medical Assessment [From emergency department arrival until completion of the initial medical assessment, assessed up to 48 hours after arrival.]: Time in minutes from registered arrival at the emergency department until the treating physician is registered as having completed the initial assessment in the electronic emergency department system.
• Time to First Antibiotic Dose [From emergency department arrival until departure from the emergency department, assessed up to 48 hours after arrival.]: Among participants receiving antibiotics in the emergency department, time in minutes from emergency department arrival to actual administration of the first antibiotic dose.
• Duration of Antibiotic Treatment [From initiation of antibiotic treatment until completion of the treatment course, assessed up to 30 days after emergency department arrival.]: Total duration of antibiotic treatment, including planned treatment continuing after hospital discharge.
• Time to First Relevant Diagnostic Imaging [From emergency department arrival until completion of the first relevant diagnostic imaging examination during the index hospitalization, assessed up to 30 days after arrival.]: Time in minutes from emergency department arrival to completion of the first relevant computed tomography or ultrasound examination.
• Time to Surgery [From emergency department arrival until start of anesthesia for surgery during the index hospitalization, assessed up to 30 days after arrival.]: Among participants undergoing surgery for the acute abdominal condition during the index hospitalization, time in minutes from registered emergency department arrival to start of anesthesia.
• Time to Invasive Intervention [From emergency department arrival until start of the first relevant invasive intervention during the index hospitalization, assessed up to 30 days after arrival.]: For patients that undergo an invasive intervention: Time in minutes from emergency department arrival to the start of the first relevant invasive intervention, including surgery, ERCP, or percutaneous image-guided intervention.
• Total Hospital Length of Stay [From emergency department arrival until discharge from the index hospitalization, assessed up to 90 days after arrival.]: Duration of the index hospitalization, measured from emergency department arrival to hospital discharge.
• Overall Patient Satisfaction [Assessed at emergency department departure or within 48 hours after departure.]: Overall satisfaction with emergency department care measured using a single 1-to-5 Likert-scale question, with higher scores indicating greater satisfaction.
• Days in Hospital Within 30 Days After Emergency Department Presentation [From the index emergency department presentation through 30 days after presentation.]: Cumulative number of days spent in hospital during the 30 days following the index emergency department presentation, including the index hospitalization and any unplanned revisits or readmissions resulting in hospital admission.

Other outcomes

• Patient Experience Score [Assessed at emergency department departure or within 48 hours after departure.]: Mean score from Likert-scale questions assessing communication and involvement during the emergency department stay. Higher scores indicate a better patient experience.

Sex: All, ages: 18 Years to any

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

• Jenkins D, Thomas SA, Pathan SA, Thomas SH. Increasing consultant-level staffing as a proportion of overall physician coverage improves emergency department length of stay targets. BMC Emerg Med. 2021 Jan 13;21(1):5. doi: 10.1186/s12873-020-00399-8. PMID 33441082
• Burgess L, Ray-Barruel G, Kynoch K. Association between emergency department length of stay and patient outcomes: A systematic review. Res Nurs Health. 2022 Feb;45(1):59-93. doi: 10.1002/nur.22201. Epub 2021 Dec 21. PMID 34932834
• Jones PG, Mountain D, Forero R. Review article: Emergency department crowding measures associations with quality of care: A systematic review. Emerg Med Australas. 2021 Aug;33(4):592-600. doi: 10.1111/1742-6723.13743. Epub 2021 Mar 16. PMID 33724707

• Dagfinn L Markussen, MD, PhD, Principal investigator, Haukeland University Hospital