Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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: Regardless of race/ethnicity, surrogates for seriously ill patients appeared to experience increased significant, multidimensional burdens of decision making under conditions of uncertainty about a patient's preferences. This aspect of the burden of surrogate decision making may not be fully appreciated by physicians. Physicians should identify and be especially attentive to strategies used by surrogates, which may vary by race/ethnicity, to reduce the uncertainty about a patient's preferences and thus the burden of surrogate decision making to assist them in this difficult process. Based on the responses of participants in Phase I, the instrument was refined and a more culturally sensitive instrument was presented to participants in Phase II. Recruitment of Hispanic patients for Phase II was challenging since the older 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. 33 surrogates and 38 patients (African Americans, Hispanics, and whites) completed structured interviews (4 subjects did not complete both interviews). All interviews were transcribed and data managed with Atlas Ti. The Values Inventory discussion aid was created based on the interviews. For the last phase (objective 3) 23,787 patients were screened for eligibility, identified 642 eligible subjects, and of those 128 patients completed the intervention. 4 case studies with surrogates were also completed. Interviews were transcribed and data analysis using Atlas Ti 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 guide the decision-making process, with particular emphasis on the role of ethnic, racial and cultural factors.


Criteria:

Inclusion Criteria: - Eligible patients will be at risk for 6-12 month mortality and have one of the following diagnoses: - congestive heart failure, with ejection fraction of <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 participants will be age 55 years or older and will be recruited through the clinics at the Houston VAMC. Exclusion Criteria: - Patients with dementia - Patients less than 55 years old


NCT ID:

NCT00122135


Primary Contact:

Principal Investigator
Ursula K. Braun, MD MPH
Michael E DeBakey VA Medical Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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