Telemedicine Abdominal Exams & Imaging

Can Telemedicine Examinations of the Abdomen Safely Determine the Need for Abdominal Imaging?

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain
• Intervention / Treatment: Other: Abdominal examination

Detailed Description

This will be a prospective, observational, blinded diagnostic concordance study of patients being seen for abdominal pain at an academic emergency department (ED) at Massachusetts General Hospital (MGH).

The study will consist of two phases. Both phases will have an on-call telemedicine physician who will assess the patient and answer the question about need for imaging.

The first phase mitigates technical issues with the telemedicine technology by using the high-resolution MGH TeleHealth Stroke Cart. This will allow telemedicine hardware that has been vetted in the high-acuity and high-reliability Acute Stroke Service and will minimize the impact of potential technical problems with iPads and wireless connectivity.

The second phase will substitute the Stroke Cart with an iPad to mimic the devices that the patients will likely be using from home in a direct-to-patient telehealth program.

Initially, we expected to enroll up to 72 subjects in 2 phases. Each phase would have needed 30 patients for significant results, and another 6 patients are estimated for patients that may become ineligible during the study visit (e.g., potential for contamination if the subject mentions the abdominal imaging plans of the in-person provider during the telemedicine examination). Phase 1 provided more information and changed our assumptions for Phase 2 sample size. We increased Phase 2 enrollment target to 60 subjects; we need 53 patients for significant results and will add 7 patients should they become ineligible during the study. Therefore, a total of 90 subjects in Phase 1 and 2 will be enrolled.

After consent, the research staff member will page the on-call study telemedicine physician and bring the stroke cart (iPad in the second phase) into the examination room. The on-call physician will connect to the secure video application and will interview and examine the patient. The telemedicine physician will not tell the patient their thoughts on what is the cause of their pain, nor tell the patient the next steps in their care. The physician will thank the patient for their time and log off of the video call. The telemedicine provider will not place orders for the patient's emergency department visit, nor will they document in the patient's chart in the electronic medical record. The telehealth provider will only perform a telehealth-based examination and answer the study questions asked by the research staff member; all responses will be recorded on the electronic data capture (EDC) system. The research staff member will notify the in-person team that the telehealth examination is complete.

The in-person examination will follow the current standard of practice with the emergency physician scheduled for that shift. The research staff member will ask the same questions to the in-person provider after their examination and record the data on the EDC.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Examination by in-person physician vs. remote physician.
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; Examination by in-person physician vs. remote physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Crico
• Investigators: Principal Investigator: Emily M Hayden, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): February 14, 2022
• Study Completion (Actual): February 16, 2022

Study Registration Dates

• First Submitted: February 2, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Emergency Department, Telemedicine, Telehealth
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: 2018P002608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently, there is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No