Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Abdominal Pain
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 19 years and 125 years
Gender
Both males and females

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 wh...

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. Target enrollment is 72 patients total over two phases. Each phase would need 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). 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.

Tracking Information

NCT #
NCT04254588
Collaborators
Crico
Investigators
Principal Investigator: Emily M Hayden Massachusetts General Hospital