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A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making (Aim3)

This study has been completed.
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00122135
First received: July 18, 2005
Last updated: November 16, 2015
Last verified: November 2015
Results First Received: July 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Cirrhosis
Colon Carcinoma
Lung Cancer
Chronic Kidney Disease
Intervention: Other: Values Inventory (VI)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Patients With VI

patients / surrogates who did receive the Values Inventory prior to their clinic appointment

Values history discussion w/physician & patient/surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed.

Patients Without VI Patients who did not receive the Values Inventory prior to their clinic visit

Participant Flow:   Overall Study
    Patients With VI     Patients Without VI  
STARTED     60     60  
COMPLETED     57     60  
NOT COMPLETED     3     0  
Withdrawal by Subject                 3                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Patients With VI Patients who filled out the Values History prior to their clinic appointment
Patients Without VI Patients who did not receive the Values History prior to their clinic appointment (usual care)
Total Total of all reporting groups

Baseline Measures
    Patients With VI     Patients Without VI     Total  
Number of Participants  
[units: participants]
  60     60     120  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     30     27     57  
>=65 years     30     33     63  
Age  
[units: years]
Mean (Full Range)
  66.4  
  (55 to 85)  
  68.4  
  (56 to 84)  
  67.4  
  (55 to 85)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     60     60     120  
Region of Enrollment  
[units: participants]
     
United States     60     60     120  



  Outcome Measures

1.  Primary:   Presence of Discussions About End of Life Care Goals/Wishes   [ Time Frame: immediate ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Difficulties in recruiting enough surrogates led to abandoning having a surrogate arm.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Ursula Braun
Organization: Center for Innovations in Quality, Effectiveness, and Safety (IQuESt), MEDVAMC, Houston, TX
phone: 832 687 1645
e-mail: ubraun@bcm.edu; ursula.braun@va.gov


Publications of Results:
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.
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.
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.


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00122135     History of Changes
Other Study ID Numbers: IIR 02-224
Study First Received: July 18, 2005
Results First Received: July 10, 2015
Last Updated: November 16, 2015
Health Authority: United States: Federal Government