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.
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
- Conditions the study is for
- Adult Inpatients Referred for Standard Echocardiography
- 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
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 group | Role | What they receive |
|---|---|---|
| HCUE-guided care | Experimental | Hand-carried ultrasound echocardiography Receives: Other: HCUE-guided care |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted1 Nov 2010 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Inpatients Referred for Standard EchocardiographyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pamela Gonzalez Sr Director Clinical Research Office, Cook County Health
- Investigators
- Brian P Lucas, MD MS FHM, Principal investigator, Stroger Hospital of Cook County
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hand-carried Ultrasound Echocardiography by Hospitalists Among Inpatients Referred for Standard Echocardiography: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01231100
- Acronym / sponsor ID
- HCUE2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 1 Nov 2010 (estimated)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCUE-guided care | Experimental | Other: HCUE-guided careHand-carried ultrasound echocardiography |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- general medicine inpatients 18 years or older who were referred for inpatient standard echocardiography by hospitalists trained in hand-carried ultrasound echocardiography
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| HCUE-guided careCare directed by hand-carried ultrasound echocardiography | Other | HCUE-guided care |
Primary outcome
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.
2 secondary outcomes
Unplanned repeat visit to hospital or emergency department
Time frame: 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.
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 15 Jun 2023.
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.
Brian P Lucas, MD MS FHM principal investigator
Stroger Hospital of Cook County
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.