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Study of Default Options in Advance Directives

Primary Purpose

COPD, Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy, Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comfort Default AD forms
Life Extension Default AD forms
Standard Default AD forms
Sponsored by
Corporal Michael J. Crescenz VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years
  • Chronic Obstructive Pulmonary Disease (COPD) with severe or very severe airflow obstruction on pulmonary function testing and or receiving or eligible to receive long-term oxygen therapy AND/OR
  • Idiopathic Pulmonary Fibrosis (IPF) AND/OR
  • Other interstitial lung disease without curative therapy AND/OR
  • Any stage 3B or 4 solid tumor AND/OR
  • Congestive Heart Failure (CHF) either New York Heart Association NYHA) class IV or NYHA class III plus 1 hospitalization in the past year
  • No previously signed advance directive in the medical record
  • Neither listed for nor considering lung or heart transplantation
  • High anticipated risk for critical illness in the next 2 years based on clinical judgment
  • Interest in thinking about filling out an Advance Directive

Exclusion Criteria:

  • Diseases for which life-extending medical therapies may be available
  • Inability to speak and/or read English proficiently
  • New clinic patients meeting the clinic provider for the first time
  • Patients being actively evaluated or already listed for transplants
  • Patients already having an AD
  • Cognitive impairment necessitating proxy consent

Sites / Locations

  • Philadelphia Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Comfort Default

Life Extension Default

Standard Default

Arm Description

ADs with pre-selected defaults that focus on providing comfort at end-of-life.

ADs with pre-selected defaults that focus on extending life.

ADs without pre-selected defaults.

Outcomes

Primary Outcome Measures

Evaluate how the setting of defaults influences the proportion of Veterans selecting comfort-oriented plans of care in real ADs
The primary outcome is the proportion of patients in each of the 3 groups who select a general plan of care that prioritizes comfort over life extension.

Secondary Outcome Measures

Assess the influence of default options in ADs on Veterans' selections of specific life-extending therapies
The proportions of patients electing to receive each of the 5 specific life-extending interventions
Determine whether setting defaults in ADs influences the proportion of time during follow-up that Veterans spend in the hospital or ICU
The proportion of time during a 6-18 month follow-up (median 1 year) that patients spend in the hospital or ICU for each AD group

Full Information

First Posted
March 19, 2013
Last Updated
June 29, 2015
Sponsor
Corporal Michael J. Crescenz VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01817686
Brief Title
Study of Default Options in Advance Directives
Official Title
Default Options in Advance Directives for Veterans With Serious Illnesses: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporal Michael J. Crescenz VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Default options represent the events or conditions that are set into place if no alternatives are actively chosen. The setting of default options has well-established effects on a broad range of human decisions, but its influence on patients' preferences for end-of-life care is only beginning to be understood. This is a 3-armed randomized clinical trial in Veterans at high risk for critical illness, assessing the impact of Advance Directive (AD) forms framed with different default options. The central goals are to assess how default options in ADs influence the end-of-life care choices made by patients at risk for critical care, and these patients' hospital and ICU utilization. The investigators hypothesize that setting defaults in real ADs will increase the proportion of Veterans selecting comfort-oriented plans of care, decrease selections of life-extending therapies such as mechanical ventilation and dialysis, and reduce the proportion of time during follow-up that Veterans spend in the hospital and/or ICU, without affecting patient satisfaction with end-of-life care planning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy, Idiopathic Pulmonary Fibrosis, Other Interstitial Lung Disease Without Curative Therapy, Congestive Heart Failure, NYHA Class IV or NYHA Class III Plus 1 Hospitalization in the Past Year, Malignancy, Any Stage 3B or 4 Solid Tumor

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comfort Default
Arm Type
Experimental
Arm Description
ADs with pre-selected defaults that focus on providing comfort at end-of-life.
Arm Title
Life Extension Default
Arm Type
Experimental
Arm Description
ADs with pre-selected defaults that focus on extending life.
Arm Title
Standard Default
Arm Type
Experimental
Arm Description
ADs without pre-selected defaults.
Intervention Type
Other
Intervention Name(s)
Comfort Default AD forms
Intervention Description
Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
Intervention Type
Other
Intervention Name(s)
Life Extension Default AD forms
Intervention Description
Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
Intervention Type
Other
Intervention Name(s)
Standard Default AD forms
Intervention Description
Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
Primary Outcome Measure Information:
Title
Evaluate how the setting of defaults influences the proportion of Veterans selecting comfort-oriented plans of care in real ADs
Description
The primary outcome is the proportion of patients in each of the 3 groups who select a general plan of care that prioritizes comfort over life extension.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Assess the influence of default options in ADs on Veterans' selections of specific life-extending therapies
Description
The proportions of patients electing to receive each of the 5 specific life-extending interventions
Time Frame
18 months
Title
Determine whether setting defaults in ADs influences the proportion of time during follow-up that Veterans spend in the hospital or ICU
Description
The proportion of time during a 6-18 month follow-up (median 1 year) that patients spend in the hospital or ICU for each AD group
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
To document feasibility of a study of Advance Directives in the Veteran population
Description
To document our ability to recruit and retain patients with advanced diseases, we will measure the proportions of patients approached for consent who enroll (consent rate), the proportion of such patients who complete their AD (completion rate), and the proportion who subsequently complete their advance care satisfaction interview (retention rate).
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Chronic Obstructive Pulmonary Disease (COPD) with severe or very severe airflow obstruction on pulmonary function testing and or receiving or eligible to receive long-term oxygen therapy AND/OR Idiopathic Pulmonary Fibrosis (IPF) AND/OR Other interstitial lung disease without curative therapy AND/OR Any stage 3B or 4 solid tumor AND/OR Congestive Heart Failure (CHF) either New York Heart Association NYHA) class IV or NYHA class III plus 1 hospitalization in the past year No previously signed advance directive in the medical record Neither listed for nor considering lung or heart transplantation High anticipated risk for critical illness in the next 2 years based on clinical judgment Interest in thinking about filling out an Advance Directive Exclusion Criteria: Diseases for which life-extending medical therapies may be available Inability to speak and/or read English proficiently New clinic patients meeting the clinic provider for the first time Patients being actively evaluated or already listed for transplants Patients already having an AD Cognitive impairment necessitating proxy consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua B Kayser, MD, MPH
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia Veterans Affairs Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Default Options in Advance Directives

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