Clinical trial NCT04254588: Telemedicine Abdominal Exams & Imaging
Official title: Can Telemedicine Examinations of the Abdomen Safely Determine the Need for Abdominal Imaging?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Pain
Keywords: Emergency Department, Telemedicine, Telehealth
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Crico
First posted: 2020-02-05
Enrollment: 86
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Requirement of imaging after abdominal examination
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Emily M Hayden
role: PRINCIPAL_INVESTIGATOR
References: