Clinical trial NCT00122135: A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
Official title: A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Cirrhosis
Colon Carcinoma
Lung Cancer
Chronic Kidney Disease
Keywords: end-of-life care
clinical decision-making
values inventory
racial disparities
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Baylor College of Medicine
First posted: 2005-07-21
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility 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
  * 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

Primary outcomes:
measure: Presence of Discussions About End of Life Care Goals/Wishes
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center
name: Ursula K. Braun, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1136/bmj.39048.475046.68.
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.
citation: 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.
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. doi: 10.1016/s0027-9684(15)31442-5.
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.
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.
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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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: 10.1016/j.pec.2013.10.013. Epub 2013 Nov 19.
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.
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 Orleans, LA.
citation: 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. 2016 Aug;14(4):330-40. doi: 10.1017/S1478951515001091. Epub 2015 Oct 13.