Trial Information

A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making

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.