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Hand-carried Ultrasound Echocardiography in the Hospital

This study has been completed.
Sponsor:
Information provided by:
John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT01231100
First received: October 27, 2010
Last updated: October 29, 2010
Last verified: October 2010
  Purpose

The purpose of this study is to investigate whether or not care guided by hospitalists equipped with hand-carried ultrasound echocardiography reduces the length of stay of general medicine inpatients who were referred for standard echocardiography.


Condition Intervention
Adult Inpatients Referred for Standard Echocardiography
Other: HCUE-guided care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Hand-carried Ultrasound Echocardiography by Hospitalists Among Inpatients Referred for Standard Echocardiography: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Unplanned repeat visit to hospital or emergency department [ Time Frame: 30 days after discharge from hospital ] [ Designated as safety issue: Yes ]
    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.

  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 453
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCUE-guided care
Hand-carried ultrasound echocardiography
Other: HCUE-guided care
Care directed by hand-carried ultrasound echocardiography
No Intervention: Standard care Other: HCUE-guided care
Care directed by hand-carried ultrasound echocardiography

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231100

Locations
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
Investigators
Principal Investigator: Brian P Lucas, MD MS FHM Stroger Hospital of Cook County
  More Information

No publications provided

Responsible Party: Brian P Lucas MD MS FHM, Stroger Hospital of Cook County
ClinicalTrials.gov Identifier: NCT01231100     History of Changes
Other Study ID Numbers: HCUE2
Study First Received: October 27, 2010
Last Updated: October 29, 2010
Health Authority: United States: Institutional Review Board (Scientific Review Committee) of Stroger Hospital, Cook County, Chicago, Illinois

ClinicalTrials.gov processed this record on November 20, 2014