Lung Cancer Clinical Trial
Official title:
A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
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.
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: To complete Objective 3 we will conduct a pilot randomized trial of the developed
Values Inventory discussion aid to test the feasibility of using it in clinical practice.
This clinicaltrials.gov number applies to Objective 3 of IIR-02-224 only (as the complete
study is a mixed-methods study with several different arms and enrollment goals). 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, and patients with chronic kidney disease on renal replacement
therapy, with previous hospitalization. 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. All
participants are African American, Hispanic, or White, reflecting the 3 major
races/ethnicities at the Houston VAMC.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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