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CHI 99-071 – HSR Study

CHI 99-071
Effectiveness of the FairCare System for Patients with Advanced Illness
Mollie Shulan, MD
Albany VA Medical Center Samuel S. Stratton, Albany, NY
Albany, NY
Funding Period: October 2000 - September 2004
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.

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.

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.

Previous analyses of QOL measure outcomes comparing FC with UC did not reach significance, however the overall direction of most of the QOL measures suggested small non-significant benefits for FC participants. The QOL scores were reanalyzed using a newly developed maximum change methodology designed to capture a global QOL benefit by combining scores from all QOL measures, but this analysis also did not reach statistical significance. Significant differences favoring FC were previously reported for frequency in formulation and documentation of ADs at both 3 months (51% vs 24%, p = .001) and 6 months (70% vs 27%, p = .000). Follow up analysis at one year indicated the difference was maintained at one year (73% vs 33%, p = .000) and at 18 months (74% vs. 36%, p = .000) for all participants. For participants who did not have any ADs at baseline, significant differences favoring FC were found at 3 months (36% to 3%, p.= 000), 6 months (54% vs 6%, p =.000), 1 year (57% vs.10%, p =.000) and at 18 months (59% vs 13%, p = .000).

The study can make a significant contribution by examining whether a specialized interdisciplinary EOL team can improve the quality of EOL care and shared decision making in CHF patients. The study has clinical and policy implications for EOL care of patients with other chronic illnesses.

External Links for this Project

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None at this time.

DRA: Aging, Older Veterans' Health and Care, Health Systems
DRE: none
Keywords: Chronic heart failure, Education (patient), End-of-life
MeSH Terms: none

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