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

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ClinicalTrials.gov Identifier: NCT00122135
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : November 10, 2015
Last Update Posted : December 14, 2015
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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)
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With VI Patients Without VI
Hide Arm/Group Description

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 who did not receive the Values Inventory prior to their clinic visit
Period Title: Overall Study
Started 60 60
Completed 57 60
Not Completed 3 0
Reason Not Completed
Withdrawal by Subject             3             0
Arm/Group Title Patients With VI Patients Without VI Total
Hide Arm/Group Description Patients who filled out the Values History prior to their clinic appointment Patients who did not receive the Values History prior to their clinic appointment (usual care) Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
  50.0%
27
  45.0%
57
  47.5%
>=65 years
30
  50.0%
33
  55.0%
63
  52.5%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
66.4
(55 to 85)
68.4
(56 to 84)
67.4
(55 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
60
 100.0%
60
 100.0%
120
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 60 participants 120 participants
60 60 120
1.Primary Outcome
Title Presence of Discussions About End of Life Care Goals/Wishes
Hide Description Qualitative content analysis of physician-patient encounters regarding presence of any type of discussion about end of life care goals/wishes
Time Frame immediate
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With VI Patients Without VI
Hide Arm/Group Description:
Patients who filled out the Values History prior to their clinic appointment
Patients who did not receive the Values History prior to their clinic appointment (usual care)
Overall Number of Participants Analyzed 57 60
Measure Type: Number
Unit of Measure: participants
13 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients With VI, Patients Without VI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .77
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame There was only a one-time physician-patient encounter for this minimum risk study and any adverse event would have been reported immediately on the day of the encounter. There was no systematic assessment for AE.
Adverse Event Reporting Description No patient reported an adverse event at the time of the study (immediately before/after physician - patient encounter. Nobody reported any adverse events later to study personnel.
 
Arm/Group Title Patients With VI Patients Without VI
Hide Arm/Group Description

Clinic encounter w/physician & patient and/or surrogate - Patients who completed the VI prior to their physician clinic encounter

Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed.

Clinic encounter w/physician & patient and/or surrogate - Patients who did not receive the VI prior to their physician clinic encounter

Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed.

All-Cause Mortality
Patients With VI Patients Without VI
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patients With VI Patients Without VI
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With VI Patients Without VI
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Difficulties in recruiting enough surrogates led to abandoning having a surrogate arm.
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
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
First Submitted: July 18, 2005
First Posted: July 21, 2005
Results First Submitted: July 10, 2015
Results First Posted: November 10, 2015
Last Update Posted: December 14, 2015