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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Saint Francis Care
ClinicalTrials.gov Identifier:
NCT01529463
First received: January 25, 2011
Last updated: February 28, 2013
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Congestive Heart Failure
Systolic Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Post Discharge Follow-up on Readmission Rates for Congestive Heart Failure Patients

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Saint Francis Care:

Primary Outcome Measures:
  • The time from hospital discharge to first hospital readmission or death. [ Time Frame: basline and 1 month ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The time from hospital discharge to unplanned hospital admission for acute decompensated heart failure. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    3 months minus baseline

  • Change in quality of life. [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]
    Kansas City Living with Cardiomyopathy Questionnaire will be analyzed using a paired t-test comparing baseline and 2 month scores.

  • Mean readmission cost for each patient for total cost for each readmission. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    Average costs for the medical management group versus the disease management group will be calculated.

  • Improvement in knowledge of Heart Failure [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]
    Atlanta Heart Failure Knowledge Test baseline score minus 2 month score


Enrollment: 21
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Disease Management

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age<18
  • Mentally incapacitated
  • Discharge to a skilled nursing facility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529463

Locations
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
Saint Francis Care
Investigators
Principal Investigator: Richard J Soucier, M.D. Saint Francis Hosptial and Medical Center
  More Information

No publications provided

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01529463     History of Changes
Other Study ID Numbers: 11-01-001-E
Study First Received: January 25, 2011
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Francis Care:
Congestive Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013