Effect of Post Discharge Follow-up on Readmission Rates for Congestive Heart Failure Patients
This study has been completed.
Information provided by (Responsible Party):
Saint Francis Care
First received: January 25, 2011
Last updated: February 28, 2013
Last verified: December 2012
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.
Congestive Heart Failure
||Observational Model: Cohort
Time Perspective: Prospective
||Effect of Post Discharge Follow-up on Readmission Rates for Congestive Heart Failure Patients
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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients hospitalized with an admitting diagnosis of acute decompensated heart failure.
- Age =/or >18
- Admitted to the Heart Failure Unit with acute decompensated heart failure
- Referred to the Congestive Heart Failure Disease Management Program
- Mentally incapacitated
- Discharge to a skilled nursing facility
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529463
|Saint Francis Hospital and Medical Center
|Hartford, Connecticut, United States, 06105 |
Saint Francis Care
||Richard J Soucier, M.D.
||Saint Francis Hosptial and Medical Center
No publications provided
||Saint Francis Care
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 25, 2011
||February 28, 2013
||United States: Institutional Review Board
Keywords provided by Saint Francis Care:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 01, 2015