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| Tracking Information | |||||
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| First Received Date ICMJE | March 15, 2005 | ||||
| Last Updated Date | October 31, 2008 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00105599 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of the FairCare System for Patients With Advanced Illness | ||||
| Official Title ICMJE | Effectiveness of the FairCare System for Patients With Advanced Illness | ||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
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| Intervention ICMJE |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 140 | ||||
| Completion Date | September 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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: |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00105599 | ||||
| Responsible Party | Shulan, Mollie - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | CHI 99-071 | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | January 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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