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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00122135 |
The goal of this research agenda is to improve the quality of end-of-life care by explicitly identifying values that will guide the decision-making process, with a particular emphasis on the role of ethnic, racial and cultural factors.
Condition | Intervention |
---|---|
Congestive Heart Failure Chronic Obstructive Pulmonary Disease Cirrhosis Colon Carcinoma Lung Cancer |
Behavioral: Individual interviews re: end-of-life decision-making Behavioral: Values history discussion w/physician & patient/surrogate |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making |
Estimated Enrollment: | 120 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1 | Behavioral: Individual interviews re: end-of-life decision-making Behavioral: Values history discussion w/physician & patient/surrogate |
Background: End-of-life decision-making is an important aspect of providing quality healthcare, especially for the elderly population. Increasingly, the appropriateness of many of these decisions is being questioned. Some invasive procedures done in seriously ill patients do not significantly alter their course, many patients die without having pain or other symptoms addressed, and families may feel dissatisfied with the care provided. Additionally, there are striking racial/ethnic disparities in end-of-life care.
Objectives: The explicit identification of values that guide medical decision-making could improve the decision-making process for end-of-life care for patients of all races/ethnicities. 1) We will directly compare, critically assess, and revise two Values Histories on the basis of qualitative data derived from individual interviews with racially/ethnically diverse patients and surrogates, and explore patients', surrogates', and physicians' values, preferences and concerns that guide decision-making about medical interventions at the end-of-life. 2) We will then adapt the existing Values Histories into a clinically practical tool, the Values Inventory discussion aid. 3) We will conduct preliminary testing of this tool to be used in physician-patient or physician-surrogate encounters to improve and facilitate decisions about end-of-life care.
Methods: Cross-sectional qualitative study using individual interviews with racially-ethnically diverse seriously ill patients and surrogates, and focus group interviews with physicians. Eligible patients are at risk for 6-12-month mortality with one of the following diagnoses: congestive heart failure, with ejection fraction of less than 25%; severe chronic obstructive pulmonary disease/emphysema with dependence on oxygen; chronic liver disease with cirrhosis and ascites; colon carcinoma with liver metastases; or non-small cell cancer of the lung, stage III or IV. All (patient) participants are age 55 years or older and are recruited through the clinics/wards at the Houston VAMC. Surrogates are surrogates of patients with such conditions; physicians are generalists and medical subspecialists. To achieve objective 3, a small randomized trial to test the feasibility of using the developed Values Inventory discussion aid in clinical practice will be done.
Findings: Based on the responses of participants in Phase I, the instrument was refined and a more culturally sensitive instrument was presentned to participants in Phase II. Recruitment of Hispanic patients for Phase II has been challenging since the Hispanic population at MEDVAMC is much smaller than the black or white population.
Status: We screened 3250 patients for eligibility into the study (objective 1), identified 192 eligible subjects, 169 subjects were contacted and 65 (38%) agreed to participate. To date, 60 racially/ethnically diverse subjects (African Americans, Hispanics, and whites) have completed structured interviews (4 subjects did not complete both interviews). All interviews have been transcribed and data are managed with Atlas Ti; analysis is ongoing. The Values Inventory discussion aid has been created based on the interviews. Recruitment for the last phase (objective 3) has begun and we have screened 23,700 patients for eligibility (objective 3), identified 642 eligible subjects, to date 138 subjects have been contacted and of those contacted 129(93%) have agreed to participate. To date, 121 subjects have completed the intervention. 5 case studies with surrogates have also been completed. The completed interviews are being transcribed and recruitment is ongoing. Data are managed with Atlas Ti and analysis is ongoing.
Impact: This project lays the foundation for formally testing the efficacy of the Values Inventory in a larger clinical trial. The long-term goal of this research agenda is to improve the quality of end-of-life care by explicitly identifying values that will guide the decision-making process, with a particular emphasis on the role of ethnic, racial and cultural factors.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Primary care clinic at a large tertiary VA Medical Center
Inclusion Criteria:
Eligible patients will be at risk for 6-12 month mortality and have one of the following diagnoses:
Exclusion Criteria:
Responsible Party: | Department of Veterans Affairs ( Braun, Ursula - Principal Investigator ) |
Study ID Numbers: | IIR 02-224 |
Study First Received: | July 18, 2005 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00122135 |
Health Authority: | United States: Federal Government |
end-of-life care clinical decision-making values inventory racial disparities |
Thoracic Neoplasms Heart Failure Lung Diseases, Obstructive Heart Diseases Respiratory Tract Diseases Fibrosis |
Lung Neoplasms Lung Diseases Liver Cirrhosis Neoplasms, Glandular and Epithelial Pulmonary Disease, Chronic Obstructive Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |
Pathologic Processes Neoplasms by Histologic Type Cardiovascular Diseases |