We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of the FairCare System for Patients With Advanced Illness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00105599
First Posted: March 16, 2005
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention Phase
Terminal Care Neoplasm Behavioral: End of life care coordination Procedure: FairCare System Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effectiveness of the FairCare System for Patients With Advanced Illness

Further study details as provided by VA Office of Research and Development:

Estimated Enrollment: 140
Study Completion Date: September 2004
Arms Assigned Interventions
Arm 1 Behavioral: End of life care coordination Procedure: FairCare System

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, (i.e. 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, i.e. 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Ejection fraction 35% or less and classification at level 3 or 4 of the New York State Heart Classification System and surrogates of patients meeting this criteria.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105599


Locations
United States, New York
Albany VA Medical Center Samuel S. Stratton, Albany, NY
Albany, New York, United States, 12208
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Mollie Shulan, MD Albany VA Medical Center Samuel S. Stratton, Albany, NY
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00105599     History of Changes
Other Study ID Numbers: CHI 99-071
First Submitted: March 15, 2005
First Posted: March 16, 2005
Last Update Posted: April 7, 2015
Last Verified: February 2007