A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making (Aim3)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00122135|
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : November 10, 2015
Last Update Posted : December 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure Chronic Obstructive Pulmonary Disease Cirrhosis Colon Carcinoma Lung Cancer Chronic Kidney Disease||Other: Values Inventory (VI)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
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
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.
- Presence of Discussions About End of Life Care Goals/Wishes [ Time Frame: immediate ]Qualitative content analysis of physician-patient encounters regarding presence of any type of discussion about end of life care goals/wishes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122135
|United States, Texas|
|Michael E DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ursula K. Braun, MD MPH||Michael E DeBakey VA Medical Center|