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Adult Inpatients Referred for Standard EchocardiographyNCT01231100

Hand-carried Ultrasound Echocardiography in the Hospital

A study testing HCUE-guided care in people with Adult Inpatients Referred for Standard Echocardiography, run by Cook County Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HCUE-guided care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
453 participants
Where
1 siteUnited States
Study dates
Jul 2008to Apr 2009
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • general medicine inpatients 18 years or older who were referred for inpatient standard echocardiography by hospitalists trained in hand-carried ultrasound echocardiography

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Stroger Hospital of Cook County

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Effects of Hand-carried Ultrasound Echocardiography by Hospitalists Among Inpatients Referred for Standard Echocardiography: a Randomized Trial

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.

Read the 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.

Being tested
HCUE-guided care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HCUE-guided careOther

    Care directed by hand-carried ultrasound echocardiography

Study groups in NCT01231100
Study groupRoleWhat they receive
HCUE-guided careExperimentalHand-carried ultrasound echocardiography
Receives: Other: HCUE-guided care
Standard careNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of stay on referring 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.

    Measured: 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 outcomes (2)
  1. Unplanned repeat visit to hospital or emergency department

    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.

    Measured: 30 days after discharge from hospital

  2. Time to performance of standard echocardiography.

    Measured: From time of admission until the time of performance of standard echocardiography, assessed up to 1 week after time of admission.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2010 (estimated)
  2. Study startJul 2008
  3. Primary completionMar 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01231100
Sponsor's protocol ID
HCUE2
Status last verified
Jun 2023
First submitted
27 Oct 2010
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing HCUE-guided care in people with Adult Inpatients Referred for Standard Echocardiography, run by Cook County Health 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 1 inclusion and 1 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 15 Jun 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?

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.). 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 15 Jun 2023.

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