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

Lung Cancer Clinical Trial

— Aim3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122135
• Other study ID #: IIR 02-224
• Status: Completed
• Phase: N/A
• First received: July 18, 2005
• Last updated: November 16, 2015
• Start date: December 2004
• Est. completion date: September 2009

Study information

• Verified date: November 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Obstructive Pulmonary Disease
• Cirrhosis
• Colon Carcinoma
• Congestive Heart Failure
• Heart Failure
• Kidney Diseases
• Lung Cancer
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Michael E DeBakey VA Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (15)

Braun U, McCullough L, Ford M, Espadas D, Beyth R. End-of-life care across race and ethnicities: Voices of patients, surrogates, and physicians. [Abstract]. Journal of the American Geriatrics Society. 2005 Apr 1; 53(s1):S137-8.

Braun U, Morgan RO, Ford ME, Beyth RJ. Who gets what? Race/ethnicity matter for treatment of seriously ill veterans. [Abstract]. Journal of the American Geriatrics Society. 2006 Apr 1; 54(S4):S180.

Braun UK, Beyth RJ, Ford ME, Espadas D, McCullough LB. Decision-making styles of seriously ill male Veterans for end-of-life care: Autonomists, Altruists, Authorizers, Absolute Trusters, and Avoiders. Patient Educ Couns. 2014 Mar;94(3):334-41. doi: 10.101 — View Citation

Braun UK, Beyth RJ, Ford ME, McCullough LB. Defining limits in care of terminally ill patients. BMJ. 2007 Feb 3;334(7587):239-41. Review. — View Citation

Braun UK, Beyth RJ, Ford ME, McCullough LB. Voices of African American, Caucasian, and Hispanic surrogates on the burdens of end-of-life decision making. J Gen Intern Med. 2008 Mar;23(3):267-74. doi: 10.1007/s11606-007-0487-7. Epub 2008 Jan 3. — View Citation

Braun UK, Ford ME, Beyth RJ, McCullough LB. The physician's professional role in end-of-life decision-making: voices of racially and ethnically diverse physicians. Patient Educ Couns. 2010 Jul;80(1):3-9. doi: 10.1016/j.pec.2009.10.018. Epub 2009 Nov 30. — View Citation

Braun UK, Ford ME, McCullough L, Beyth RJ. Discussing End-of-Life Decision Making: Views of Racially and Ethnically Diverse Physicians. [Abstract]. The Journal of Nutrition, Health & Aging. 2006 Aug 1; 10(4):332.

Braun UK, Kunik ME, Pham C. Treating depression in terminally ill patients can optimize their physical comfort at the end of life and provide them the opportunity to confront and prepare for death. Geriatrics. 2008 Jun;63(6):25-7. Review. — View Citation

Braun UK, McCullough LB, Beyth RJ, Wray NP, Kunik ME, Morgan RO. Racial and ethnic differences in the treatment of seriously ill patients: a comparison of African-American, Caucasian and Hispanic veterans. J Natl Med Assoc. 2008 Sep;100(9):1041-51. — View Citation

Braun UK, McCullough LB. Preventing life-sustaining treatment by default. Ann Fam Med. 2011 May-Jun;9(3):250-6. doi: 10.1370/afm.1227. — View Citation

Braun UK, Naik AD, McCullough LB. Reconceptualizing the experience of surrogate decision making: reports vs genuine decisions. Ann Fam Med. 2009 May-Jun;7(3):249-53. doi: 10.1370/afm.963. — View Citation

Menon S, McCullough LB, Beyth RJ, Ford ME, Espadas D, Braun UK. Feasibility of Using a Values Inventory as a Discussion Aid about End-of-Life Care. Poster session presented at: Gerontological Society of America Annual Scientific Meeting; 2010 Nov 21; New

Menon S, McCullough LB, Beyth RJ, Ford ME, Espadas D, Braun UK. Use of a values inventory as a discussion aid about end-of-life care: A pilot randomized controlled trial. Palliat Support Care. 2015 Oct 13:1-11. [Epub ahead of print] — View Citation

Nambiar A, McCullough L, Ford M, Beyth R, Braun UK. Discussing End-of-Life Decision Making: Views of Racially and Ethnically Diverse Physicians. [Abstract]. The Gerontologist. 2006 Oct 1; 46(Special Issue 1):402.

Pham C, Braun UK. Racial and Ethnic Differences in End-of-Life Care for Patients with End-Stage Renal Disease. [Abstract]. Journal of pain and symptom management. 2009 Mar 1; 37(3):556-557.

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Discussions About End of Life Care Goals/Wishes	Qualitative content analysis of physician-patient encounters regarding presence of any type of discussion about end of life care goals/wishes	immediate	No