CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Failure Study (CRUSH)

CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Study

This is a study to determine if two ultrasound measures (Corrected Flow Time and B-Lines) can predict patients at higher risk of readmission within 30 days of hospital discharge for decompensated heart failure.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Vascular and Pulmonary Ultrasound

Detailed Description

Heart failure (HF) resulting in congestion is the leading cause for admission in persons ≥65 years of age and 20-25% of such patients are readmitted within 30 days of discharge. Efforts to treat HF are difficult without a simple method to detect early signs of congestion to direct therapy. Ultrasound can detect evidence of congestion by increased cardiac filling pressures two weeks prior to other markers of congestion such as weight gain or patient symptoms. Corrected flow time (FTc) measured by ultrasound, is an easy to perform vascular measure and correlates with cardiac filling pressures. Despite the relationship between FTc and filling pressures, this measure has never been studied in HF. The primary aim is to determine if FTc can predict patients at risk of readmission within 30 days. As a secondary aim, the investigators plan to validate a small study of patients reporting the ability of pulmonary ultrasound to predict readmissions. This study demonstrated pulmonary ultrasound was 100% sensitive and 68% specific for predicting readmission at 3 months, however this investigation was small and validation is needed. It is expected ultrasound will be able to accurately and safely predict patients who will be readmitted within 30 days of discharge. This proposal is aimed at identifying a noninvasive measure to better assess congestion from HF and predict readmissions.

• Study Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02119
      • Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized with a diagnosis of acute decompensated heart failure.

Description

Inclusion Criteria:

• English Speaking
• Being admitted for heart failure with expected hospital stay of 72 hours

Exclusion Criteria:

• Unable to provide consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Heart Failure; Patients admitted to the hospital with acute decompensated heart failure expected to be hospitalized for at least 72 hours	Other: Vascular and Pulmonary Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Corrected Flow Time	Daily corrected flow time measures will be obtained during hospitalization. Mean hospitalization time for the study population is 9 days, but will be measured during the duration of their hospitalization. Changes in corrected flow time values will be assessed for associations with 30 day return visits. 30 Day returns will be determined by medical record review as well as follow up phone calls to patients. Corrected Flow Time is a single measure performed serial with the same units of measure.	Measured daily during hospitalization and then correlated to 30 day readmissions.Mean hospitalization for the study population is 9 days, but will be measured during the duration of their hospitalization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pulmonary Ultrasound (B-Lines)	Daily pulmonary ultrasound measures will be obtained during hospitalization. Mean hospitalization time for the study population is 9 days, but will be measured for the duration of their hospitalization. Changes in lung ultrasound values will be assessed for associations with 30 day return visits. 30 Day returns will be determined by medical record review as well as follow up phone calls to patients. Lung Ultrasound is a single measure performed serial with the same units of measure.	Measured daily during hospitalization and correlated to 30 day readmissions. Mean hospitalization time for the study population is 9 days, but will be measured during the duration of hospitalization.

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Emergency Medicine Foundation; Heart Failure Society of America
• Investigators: Principal Investigator: Joseph Pare, MD MHS RDMS, Assistant Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (ESTIMATE): December 19, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: H-35112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO