- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01231100
Hand-carried Ultrasound Echocardiography in the Hospital
Effects of Hand-carried Ultrasound Echocardiography by Hospitalists Among Inpatients Referred for Standard Echocardiography: a Randomized Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
This was an unblinded, parallel-group, superiority trial that randomized participants in a balanced (1:1) allocation ratio. We made no changes to our protocol after we began enrollment. Nor did we conduct any interim analyses. Each morning of the study period, including weekends and holidays, investigators listed all consecutive patients who were newly referred for SE by participating hospitalists. After hospitalists completed their initial evaluation of each patient, which included a history, physical exam, and review of medical records, investigators asked them to choose their indications for SE from a closed list. Given these indications, investigators then asked if HCUE could help them to assess their patients; if not, investigators excluded such patients. Finally, hospitalists were asked for their current management plans, which included medication regimens, diagnostic tests, specialty consultations, and timing of hospital discharge. If hospitalists remained masked to any preliminary SE results, investigators assigned participants who gave written informed consent to an intervention group. We used a computer-generated list of random numbers for the allocation sequence, and we concealed the sequence in an on-site computer system that only released allocations to investigators after they entered participant identifiers.
Hospitalists either awaited SE results for participants randomized to usual care or they performed HCUE for participants randomized to HCUE-guided care. Hospitalists performed HCUE with a MicroMaxx 3.4 hand-carried ultrasound machine equipped with a cardiology software package and a 1 to 5 MHz P17 cardiac transducer (Sonosite, Inc., Bothell, WA). The details of the HCUE protocol are described elsewhere. In brief, without assistance from nursing staff, hospitalists positioned participants on standard hospital beds and recorded 7 best-quality images up to 6 seconds in duration. Then hospitalists replayed the images for immediate interpretation. They made linear measurements with a caliper held directly to the ultrasound monitor and translated them into qualitative assessments based on simplified standard values.
The primary outcome was the length of stay on the short stay unit or general medicine ward service of the referring hospitalist. The duration began when the patient was admitted to the hospitalist service and ended when the patient was discharged home or transferred to a different service in the hospital. We chose this duration, rather than the length of stay of the entire hospitalization, because we wanted the primary outcome to reflect how HCUE affected hospitalists' management decisions in the hospital, including the transfer of participants to other services.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Stroger Hospital of Cook County
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- general medicine inpatients 18 years or older who were referred for inpatient standard echocardiography by hospitalists trained in hand-carried ultrasound echocardiography
Exclusion Criteria:
- referring hospitalist not being masked to standard echocardiography results and determination by the referring hospitalist that hand-carried ultrasound echocardiography was unlikely to help given the indications for standard echocardiography
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard care
|
|
Experimental: HCUE-guided care
Hand-carried ultrasound echocardiography
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Care directed by hand-carried ultrasound echocardiography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay on referring hospitalist's service
Time Frame: From date of randomization until the date of tranfer off the referring hospitalist's service (including death from any cause), assessed up to 1 month after admission to the hospitalist's service.
|
The length of stay begins when the patient arrives on the referring hospitalist's service and end when the patient leaves the referring hospitalist's service.
|
From date of randomization until the date of tranfer off the referring hospitalist's service (including death from any cause), assessed up to 1 month after admission to the hospitalist's service.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unplanned repeat visit to hospital or emergency department
Time Frame: 30 days after discharge from hospital
|
From date of discharge from the hospital and from the referring hospitalist's service until an unplanned visit back to our hospital or emergency department, assessed up to 30 days after discharge.
|
30 days after discharge from hospital
|
Time to performance of standard echocardiography.
Time Frame: From time of admission until the time of performance of standard echocardiography, assessed up to 1 week after time of admission.
|
From time of admission until the time of performance of standard echocardiography, assessed up to 1 week after time of admission.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian P Lucas, MD MS FHM, Stroger Hospital of Cook County
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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
- HCUE2
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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