Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105599
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-03-15
Brief Title:
Effectiveness of the FairCare System for Patients With Advanced Illness
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effectiveness of the FairCare System for Patients With Advanced Illness
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study of the FairCare Program FC is designed to address end of life EOL care delivery issues by reducing barriers to effective EOL care among health care providers family members surrogates and Chronic Heart Failure CHF patients using a comprehensive multi-pronged approach delivered by a care coordinator and supported by an interdisciplinary team
Detailed Description:
Background
This study of the FairCare Program FC is designed to address end of life EOL care delivery issues by reducing barriers to effective EOL care among health care providers family members surrogates and Chronic Heart Failure CHF patients using a comprehensive multi-pronged approach delivered by a care coordinator and supported by an interdisciplinary team
Objectives
Evaluate the impact of FC on 1 improving the quality of life QOL and health care delivery for CHF patients with advanced illness ie ejection fractions of 35 or less or assessed as level III or IV on the NYS Heart Association Classification System 2 addressing their fears about dying 3 increasing their use of Advance Directives ADs and 4 improving provider compliance with ADs Also describe trends that may occur in disease-specific QOL survival and health care use and cost
Methods
The study employs a randomized control group design There are two treatment arms the FC treatment condition and the usual care UC control condition Assessments for improving quality of life QOL and quality of care delivery are taken at baseline and at three and six months Assessments of AD use ie frequency of formulation and documentation of ADs are taken at baseline three and six months at one year and 18 months Because data about compliance with ADs and utilization and cost may not be fully comprehensive until patients deaths to maximize the sample size for these variables and hence the power of the study to detect difference in these outcomes data on compliance with ADs will be collected in the final year of the study and data on utilization and cost will be aggregated in monthly intervals and collected from baseline to 18 months One year of VA pre-intervention health care utilization and cost data will also be collected to assess baseline utilization and to control for any pre-existing differences in the propensity of patients to use health care services Also an intention to treat methodology will be used during data analyses
Status
The study ends 9-30-04 data for VA cost Medicare cost consistency of medical care with patient preferences and survival are being collected and analyzed for the final report
This study of the FairCare Program FC is designed to address end of life EOL care delivery issues by reducing barriers to effective EOL care among health care providers family members surrogates and Chronic Heart Failure CHF patients using a comprehensive multi-pronged approach delivered by a care coordinator and supported by an interdisciplinary team
Objectives
Evaluate the impact of FC on 1 improving the quality of life QOL and health care delivery for CHF patients with advanced illness ie ejection fractions of 35 or less or assessed as level III or IV on the NYS Heart Association Classification System 2 addressing their fears about dying 3 increasing their use of Advance Directives ADs and 4 improving provider compliance with ADs Also describe trends that may occur in disease-specific QOL survival and health care use and cost
Methods
The study employs a randomized control group design There are two treatment arms the FC treatment condition and the usual care UC control condition Assessments for improving quality of life QOL and quality of care delivery are taken at baseline and at three and six months Assessments of AD use ie frequency of formulation and documentation of ADs are taken at baseline three and six months at one year and 18 months Because data about compliance with ADs and utilization and cost may not be fully comprehensive until patients deaths to maximize the sample size for these variables and hence the power of the study to detect difference in these outcomes data on compliance with ADs will be collected in the final year of the study and data on utilization and cost will be aggregated in monthly intervals and collected from baseline to 18 months One year of VA pre-intervention health care utilization and cost data will also be collected to assess baseline utilization and to control for any pre-existing differences in the propensity of patients to use health care services Also an intention to treat methodology will be used during data analyses
Status
The study ends 9-30-04 data for VA cost Medicare cost consistency of medical care with patient preferences and survival are being collected and analyzed for the final report
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None