Congestive Heart FailureAim3NCT00122135
A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
A study testing Values Inventory (VI) in people with Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Cirrhosis
- What is being tested?
- Values Inventory (VI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with dementia
- Patients less than 55 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Cirrhosis, Colon Carcinoma, Lung Cancer, Chronic Kidney Disease
- Being tested
- Values Inventory (VI)
- Keywords
- end-of-life care, clinical decision-making, values inventory, racial disparities
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Fibrosis, Colonic Neoplasms, Lung Neoplasms, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Values Inventory (VI)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients without Values Inventory (VI) | No intervention | Clinic encounter w/physician \& patient and/or surrogate - Patients who did not receive the VI prior to their physician clinic encounter |
| Patients with Values Inventory (VI) | Experimental | Clinic encounter w/physician \& patient and/or surrogate - Patients who completed the VI prior to their physician clinic encounter Receives: Other: Values Inventory (VI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startDec 2004
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Ursula K. Braun, MD MPH, Principal investigator, Michael E. DeBakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122135
- Sponsor's protocol ID
- IIR 02-224
- Acronym
- Aim3
- Status last verified
- Nov 2015
- First submitted
- 18 Jul 2005
- Last updated
- 14 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17272566Braun 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.
PubMed 18172738Braun 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.
PubMed 18512998Braun 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.
PubMed 18807433Braun 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.
PubMed 19433843Braun 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.
PubMed 19948388Braun 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.
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.
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 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.
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.
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.
PubMed 24365071Braun UK, McCullough LB. Preventing life-sustaining treatment by default. Ann Fam Med. 2011 May-Jun;9(3):250-6. doi: 10.1370/afm.1227.
PubMed 21555753Menon 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.
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.
PubMed 26458331
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
- ClinicalTrials.gov ID
- NCT00122135
- Acronym / sponsor ID
- Aim3 / IIR 02-224
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Baylor College of Medicine
- Study start
- Dec 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Jul 2005 (estimated)
- Results
- Posted 10 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without Values Inventory (VI) | No intervention | –Clinic encounter w/physician \& patient and/or surrogate - Patients who did not receive the VI prior to their physician clinic encounter |
| Patients with Values Inventory (VI) | Experimental | Other: Values Inventory (VI)Clinic encounter w/physician \& patient and/or surrogate - Patients who completed the VI prior to their physician clinic encounter |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eligible patients will be at risk for 6-12 month mortality and have one of the following diagnoses:
- All participants will be age 55 years or older and will be recruited through the clinics at the Houston VAMC.
Key exclusion criteria (2 listed)
- Patients with dementia
- Patients less than 55 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients with Values Inventory (VI) |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17272566Braun 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.
- Results publication: PubMed 18172738Braun 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.
- Results publication: PubMed 18512998Braun 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.
- Results publication: PubMed 18807433Braun 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.
- Results publication: PubMed 19433843Braun 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.
- Results publication: PubMed 19948388Braun 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.
- Results publicationBraun 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.
- Results publicationNambiar 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.
- Results publicationBraun 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.
- Results publicationBraun 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.
- Results publicationPham 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.
- Results publication: PubMed 24365071Braun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursula K. Braun, MD MPH principal investigator
Michael E. DeBakey VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Values Inventory (VI) in people with Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Discussions About End of Life Care Goals/Wishes (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00122135, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.