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

NCT07815795 | Not Yet Recruiting DMC

• 1 other identifier: 983088
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Pain (AP); Acute Abdomen; Acute Abdominal Pain; Abdomen, Acute

Keywords

Emergency Medicine; Emergency Department; Acute Abdominal Pain; Patient Flow; Length of Stay; Pragmatic Randomized Trial; Health Services Research

Outcome Measures

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.

  From registered arrival at the emergency department until departure from the emergency department, assessed up to 48 hours.

Secondary Outcomes (21)

• Tentative Diagnosis Documented

  Within 48 hours of emergency department arrival.

• Diagnostic Agreement

  From emergency department arrival until discharge from the index hospitalization, assessed up to 30 days after arrival.

• Use of Computed Tomography

  Within the first 24 hours of the index hospitalization

• Use of Ultrasound

  Within the first 24 hours of the index hospitalization

• Assessment by a More Experienced Surgical Physician

  From emergency department arrival until departure from the emergency department, assessed up to 48 hours after arrival.

Other Outcomes (1)

• Patient Experience Score

  Assessed at emergency department departure or within 48 hours after departure.

Study Arms (2)

Emergency Medicine Initial Assessment

EXPERIMENTAL

Participants randomized to this arm will receive their initial assessment and management in the emergency department from an experienced emergency medicine physician (senior resident or consultant in emergency medicine). The emergency medicine physician will have primary responsibility for the initial clinical assessment, diagnostic work-up, initiation of treatment, and decisions regarding further disposition. Gastrointestinal surgeons or other relevant specialists will be involved when clinically indicated.

Other: Emergency Medicine Initial Assessment

Standard Surgical Assessment

ACTIVE COMPARATOR

Participants randomized to this arm will receive 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.

Other: Standard Surgical Assessment

Interventions

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.

Emergency Medicine Initial Assessment

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.

Standard Surgical Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5020, Norway

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Abdominal Pain; Abdomen, Acute; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Disease Attributes; Pathologic Processes

Study Officials

• Dagfinn L Markussen, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dagfinn L Markussen, MD, PhD

CONTACT

55 97 50 00; dafi@ihelse.net

Hilde Halland, MD, PhD

CONTACT

55 97 50 00

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and treating clinicians cannot be blinded to group allocation. Outcome assessors evaluating diagnostic accuracy will be blinded to treatment allocation. The primary outcome and most other outcomes are based on objective data obtained from the electronic health record.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are individually randomized in a 1:1 ratio to one of two parallel care pathways: initial assessment and management by an experienced emergency medicine physician, or standard surgical assessment according to usual care. Participants remain in their assigned group for the primary intention-to-treat analysis regardless of subsequent crossover or final diagnosis.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 11, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)