Effect of Post Discharge Follow-up on Readmission Rates for Congestive Heart Failure Patients

NCT01529463 | Completed

• 1 other identifier: 11-01-001-E
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the hypothesis that a comprehensive post-discharge disease management system is more effective in reducing the readmission rate for heart failure patients compared to standard care.

Conditions

Congestive Heart Failure; Systolic Dysfunction

Keywords

Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• The time from hospital discharge to first hospital readmission or death.

  The primary endpoint will be assessed as a continuous variable. Survival curves will be produced using Kaplan-Meier analysis for both the CHF Disease Management Group and the case control group. A Cox regression-based test will be used to test differences in survival between the CHF Disease Management Group and the case control group. If case control subjects cannot be exactly matched on covariates to CHF Disease Management subjects, inverse probability of treatment weights (obtained via logistic regression) will be applied to correct for covariate imbalances between the two groups.

  basline and 1 month

Secondary Outcomes (4)

• The time from hospital discharge to unplanned hospital admission for acute decompensated heart failure.

  baseline and 3 months

• Change in quality of life.

  baseline and 2 months

• Mean readmission cost for each patient for total cost for each readmission.

  baseline and 3 months

• Improvement in knowledge of Heart Failure

  baseline and 2 months

Study Arms (1)

Disease Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized with an admitting diagnosis of acute decompensated heart failure.

You may qualify if:

• Age =/or \>18
• Admitted to the Heart Failure Unit with acute decompensated heart failure
• Referred to the Congestive Heart Failure Disease Management Program

You may not qualify if:

• Age\<18
• Mentally incapacitated
• Discharge to a skilled nursing facility

Sponsors & Collaborators

• Trinity Health Of New England: lead

Study Sites (1)

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Richard J Soucier, M.D.

  Saint Francis Hosptial and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: February 8, 2012
• Study Start: January 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 1, 2013

Record last verified: 2012-12

Locations

US (1)