Telemedicine Abdominal Exams & Imaging

Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254588
• Other study ID #: 2018P002608
• Status: Completed
• Start date: February 10, 2020
• Est. completion date: February 16, 2022

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 16, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Other:
• Abdominal examination
Examination by in-person physician vs. remote physician.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Crico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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