Telemedicine Abdominal Exams & Imaging

NCT04254588 | Completed

• 1 other identifier: 2018P002608
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

A study of patients with abdominal pain being seen by physicians at an academic emergency department and by physicians who are based remotely (telehealth). Hypothesis: When a patient with abdominal pain is examined by a physician at the hospital versus a physician who is remote (i.e. not at the hospital), they will agree most of the time for the need of abdominal imaging for the patient within 12 hours of their examination.

Conditions

Abdominal Pain

Keywords

Emergency Department, Telemedicine, Telehealth

Outcome Measures

Primary Outcomes (1)

• Requirement of imaging after abdominal examination

  Questionnaire agreement (yes no) between the in-person and telehealth physicians for the requirement of imaging after abdominal examination.

  12 hours

Study Arms (2)

Phase I: Adult patients with abdominal pain

Adult patients with abdominal pain presenting to the MGH ED between February and March 2020.

Other: Abdominal examination

Phase II: Adult patients with abdominal pain

Adult patients with abdominal pain presenting to the MGH ED between July and December 2021.

Other: Abdominal examination

Interventions

Abdominal examination OTHER

Examination by in-person physician vs. remote physician.

Phase I: Adult patients with abdominal pain; Phase II: Adult patients with abdominal pain

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

English-speaking patients \>19 years of age, presenting to the MGH Emergency Department with abdominal pain will be eligible for the study. Women who are known to be pregnant will be excluded from the study. Patients will be excluded from the study if they have altered mental status or who are critically ill or unstable. Altered mental status patients will be excluded because they would not be able to consistently participate in a patient-assisted physical examination by following the provider's verbal directions. Critical illness or patients who are unstable will be excluded from the study if they are triaged to the critical care area (Acute) of the MGH Emergency Department.

You may qualify if:

• Patient presenting to the MGH Emergency Department with abdominal pain
• English-speaking

You may not qualify if:

• Known to be pregnant
• Patients with altered mental status
• Patients who are critically ill or unstable

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Crico: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Abdominal Pain; 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

• Emily M Hayden

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician and Director of Telemedicine, Department of Emergency Medicine

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 5, 2020
• Study Start: February 10, 2020
• Primary Completion: February 14, 2022
• Study Completion: February 16, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)