Abdominal PainNCT04254588
Telemedicine Abdominal Exams & Imaging
An observational study of Abdominal Pain, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Abdominal examination
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 16 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient presenting to the MGH Emergency Department with abdominal pain
- English-speaking
Who cannot join
- Known to be pregnant
- Patients with altered mental status
- Patients who are critically ill or unstable
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Abdominal Pain
- Being tested
- Abdominal examination
- Keywords
- Emergency Department, Telemedicine, Telehealth
- Medical subject headings
- Abdominal Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal examinationOther
Examination by in-person physician vs. remote physician.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Adult patients with abdominal pain | Adult patients with abdominal pain presenting to the MGH ED between February and March 2020. Receives: 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. Receives: Other: Abdominal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start10 Feb 2020
- Primary completion14 Feb 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Crico
- Responsible party
- Principal investigator, Emily Marie Hayden, Massachusetts General Hospital
- Investigators
- Emily M Hayden, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254588
- Sponsor's protocol ID
- 2018P002608
- Status last verified
- Dec 2023
- First submitted
- 2 Feb 2020
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Telemedicine Examinations of the Abdomen Safely Determine the Need for Abdominal Imaging?
- ClinicalTrials.gov ID
- NCT04254588
- Acronym / sponsor ID
- 2018P002608
- Conditions
- Abdominal Pain
- Keywords
- Emergency Department, Telemedicine, Telehealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Crico
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I: Adult patients with abdominal pain | – | Other: Abdominal examinationAdult patients with abdominal pain presenting to the MGH ED between February and March 2020. |
| Phase II: Adult patients with abdominal pain | – | Other: Abdominal examinationAdult patients with abdominal pain presenting to the MGH ED between July and December 2021. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patient presenting to the MGH Emergency Department with abdominal pain
- English-speaking
Key exclusion criteria (3 listed)
- Known to be pregnant
- Patients with altered mental status
- Patients who are critically ill or unstable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal examinationExamination by in-person physician vs. remote physician. | Other | Phase I: Adult patients with abdominal pain, Phase II: Adult patients with abdominal pain |
Primary outcome
Requirement of imaging after abdominal examination
Time frame: 12 hours
Questionnaire agreement (yes no) between the in-person and telehealth physicians for the requirement of imaging after abdominal examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No. Currently, there is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily M Hayden principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Requirement of imaging after abdominal examination (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.