Hand-carried Ultrasound Echocardiography in the Hospital

NCT ID: NCT01231100

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-04-30

Brief 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.

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.

Conditions

Adult Inpatients Referred for Standard Echocardiography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HCUE-guided care

Hand-carried ultrasound echocardiography

Group Type: EXPERIMENTAL

HCUE-guided care

Intervention Type: OTHER

Care directed by hand-carried ultrasound echocardiography

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HCUE-guided care

Care directed by hand-carried ultrasound echocardiography

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cook County Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Pamela Gonzalez Sr Director Clinical Research Office

Dir Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian P Lucas, MD MS FHM

Role: PRINCIPAL_INVESTIGATOR

Stroger Hospital of Cook County

Locations

Stroger Hospital of Cook County

Chicago, Illinois, United States

Countries

United States

Other Identifiers

HCUE2

Identifier Type: -

Identifier Source: org_study_id