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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00122135
First received: July 18, 2005
Last updated: April 25, 2014
Last verified: April 2014
  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.


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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Observational study - end of life decision making [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 203
Study Start Date: December 2004
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
patients and surrogates
Behavioral: Individual interviews re: end-of-life decision-making
38 interviews with patients and 33 interviews with surrogates were conducted
Behavioral: Values history discussion w/physician & patient/surrogate
128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic at a large tertiary VA Medical Center

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122135

Locations
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Ursula K. Braun, MD MPH Michael E DeBakey VA Medical Center
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00122135     History of Changes
Other Study ID Numbers: IIR 02-224
Study First Received: July 18, 2005
Last Updated: April 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
end-of-life care
clinical decision-making
values inventory
racial disparities

Additional relevant MeSH terms:
Carcinoma
Heart Failure
Liver Cirrhosis
Fibrosis
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Neoplasms
Lung Diseases, Obstructive
Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Heart Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 23, 2014