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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00122135
• Collaborator: Baylor College of Medicine (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 57
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

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)	N/A

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

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• 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: Dec 1, 2004
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Presence of Discussions About End of Life Care Goals/Wishes [immediate]

   Qualitative content analysis of physician-patient encounters regarding presence of any type of discussion about end of life care goals/wishes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michael E DeBakey VA Medical Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• VA Office of Research and Development
• Baylor College of Medicine

Investigators

• Principal Investigator: Ursula K. Braun, MD MPH, Michael E. DeBakey VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00122135
• Other Study ID Numbers: IIR 02-224
• First Posted: Jul 21, 2005
• Last Update Posted: Dec 14, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by VA Office of Research and Development: end-of-life care; clinical decision-making; values inventory; racial disparities
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Kidney Diseases; Renal Insufficiency, Chronic; Heart Failure; Death

Study Results

Participant Flow

Arm/Group Title	Patients With VI	Patients Without VI
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

Baseline Characteristics

Arm/Group Title	Patients With VI	Patients Without VI	Total
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 Participants	60	60	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 50%	27 45%	57 47.5%
>=65 years	30 50%	33 55%	63 52.5%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	66.4	68.4	67.4
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	60 100%	60 100%	120 100%
Region of Enrollment (participants) [Number]
United States	60 100%	60 100%	120 100%

Outcome Measures

1. Primary Outcome

Title	Presence of Discussions About End of Life Care Goals/Wishes
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With VI	Patients Without VI
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)
Measure Participants	57	60
Number [participants]	13 21.7%	8 13.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patients With VI, Patients Without VI
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.77
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Patients With VI		Patients Without VI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Patients With VI		Patients Without VI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)

Limitations/Caveats

Difficulties in recruiting enough surrogates led to abandoning having a surrogate arm.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.