A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making (Aim3)

This study has been completed.
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00122135
First received: July 18, 2005
Last updated: November 16, 2015
Last verified: November 2015

July 18, 2005
November 16, 2015
December 2004
September 2009   (final data collection date for primary outcome measure)
Presence of Discussions About End of Life Care Goals/Wishes [ Time Frame: immediate ] [ Designated as safety issue: No ]
Qualitative content analysis of physician-patient encounters regarding presence of any type of discussion about end of life care goals/wishes
Not Provided
Complete list of historical versions of study NCT00122135 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Congestive Heart Failure
  • Chronic Obstructive Pulmonary Disease
  • Cirrhosis
  • Colon Carcinoma
  • Lung Cancer
  • Chronic Kidney Disease
Other: Values Inventory (VI)
The Values Inventory was given to patients for self-administration while they were awaiting their clinic appointment. They were instructed to bring it to their physician's attention right at the beginning of their clinic visit.
  • No Intervention: Patients without Values Inventory (VI)
    Clinic encounter w/physician & patient and/or surrogate - Patients who did not receive the VI prior to their physician clinic encounter
  • Experimental: Patients with Values Inventory (VI)
    Clinic encounter w/physician & patient and/or surrogate - Patients who completed the VI prior to their physician clinic encounter
    Intervention: Other: Values Inventory (VI)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
September 2009
September 2009   (final data collection date for primary outcome measure)

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
    • chronic kidney disease on renal replacement therapy, with previous hospitalization
  • 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
Both
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00122135
IIR 02-224
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Baylor College of Medicine
Principal Investigator: Ursula K. Braun, MD MPH Michael E DeBakey VA Medical Center
VA Office of Research and Development
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP