- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07546071
Telemedicine-Based Emergency Physician Assessment Prior to ED Entry: A Randomized Controlled Trial
Randomized Controlled Trial Comparing the Safety and Efficiency of a Virtual-Hybrid Emergency Department Model Versus Standard Emergency Department Management in Non-Urgent Patients
Background:
Emergency department (ED) overcrowding is a growing challenge worldwide and is associated with prolonged length of stay (LOS), reduced patient satisfaction, and increased burden on healthcare systems. New approaches are needed to improve how patients are evaluated and treated.
Telemedicine has been increasingly integrated into ED care and has shown feasibility and benefits in various settings. Existing models have demonstrated improvements in patient flow, reduced length of stay, and high patient satisfaction. However, despite the growing use of telemedicine in emergency medicine, there is a lack of randomized controlled trials evaluating its effectiveness and safety, particularly in models involving early remote physician assessment prior to ED evaluation.
Purpose:
This study aims to evaluate whether a video consultation with a senior emergency physician before entering the ED can improve the efficiency and quality of care. The study also examines whether physicians can accurately identify which patients need ED evaluation based on a remote assessment, while maintaining patient safety.
Methods:
A total of 200 adults who arrived at the ED were assigned to one of two groups. In the study group, participants had a video consultation with a physician before continuing with standard ED care.
In the control group, participants received standard ED care only.
During the video consultation, the physician performed an initial clinical assessment and could order tests or specialist consultations. The physician was also asked what their recommendation would have been if the participant had been assessed from home. Three possible decisions were recorded:
- Immediate ED presentation
- Scheduled ED presentation at a later time
- Continued care in the community without ED presentation
Outcomes:
The primary outcomes focus on the effectiveness of the intervention. These include:
- ED length of stay
- Patient satisfaction
- The ability of physicians to accurately identify participants who require ED evaluation The secondary outcome is safety, assessed by return visits to the ED within one week for the same complaint.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ramat Gan, Israel
- Sheba Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years and older
- Presentation to the emergency department during study recruitment hours
- Ability to provide written informed consent
Exclusion Criteria:
- Pregnancy
- Arrival by ambulance
- Severe pain, defined as a Visual Analogue Scale (VAS) score of 8 or higher
- Emergency Severity Index (ESI) level 1 or 2
- Language barriers or technological difficulties without an accompanying person able to assist
- Isolated orthopedic complaints with suspected fracture or dislocation
- Repeat emergency department visit for the same complaint within the previous 72 hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group / Telemedicine Group
Participants undergo an initial video consultation with a senior emergency physician prior to continuing with standard emergency department care.
|
Participants undergo an initial video consultation with a senior emergency physician prior to continuing with standard emergency department care.
The consultation includes a clinical assessment and may involve ordering diagnostic tests or specialist consultations.
|
|
No Intervention: Control Group
Participants receive standard emergency department care without a prior video consultation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency Department Length of Stay
Time Frame: From emergency department registration to the final decision regarding discharge or hospital admission during the index visit, up to 24 hours.
|
Emergency department length of stay, defined as the time from emergency department registration to discharge or hospital admission during the index visit, measured in hours.
Data will be extracted from the hospital electronic medical record one week after the visit.
|
From emergency department registration to the final decision regarding discharge or hospital admission during the index visit, up to 24 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return Visits to the Emergency Department
Time Frame: Within one week after the ED visit
|
Return visits to the emergency department within one week for the same complaint.
|
Within one week after the ED visit
|
|
Accuracy of Physician Assessment for ED Referral
Time Frame: From the baseline physician assessment at the initial video consultation, to the final clinical outcome at the end of the index visit (discharge or hospital admission), up to 24 hours.
|
The ability of physicians to identify participants requiring emergency department evaluation based on the initial video consultation, assessed by comparing physician recommendations to actual clinical outcomes.
|
From the baseline physician assessment at the initial video consultation, to the final clinical outcome at the end of the index visit (discharge or hospital admission), up to 24 hours.
|
|
Patient Satisfaction
Time Frame: One week after the ED visit
|
Patient satisfaction will be assessed using the Short Assessment of Patient Satisfaction (SAPS) questionnaire, administered via SMS one week after the emergency department visit.
The SAPS is a validated 7-item questionnaire that assesses multiple aspects of patient satisfaction.
Total scores range from 0 to 28, with higher scores indicating greater patient satisfaction.
Scores of 0 to 10 indicate Very dissatisfaction, 11 to 18 indicate dissatisfaction, 19 to 26 indicate satisfaction, and 27 to 28 indicate very high satisfaction.
|
One week after the ED visit
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SMC-2688-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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