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Study of Default Options in Advance Directives

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Philadelphia Veterans Affairs Medical Center
Sponsor:
Information provided by (Responsible Party):
Joshua B. Kayser, Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01817686
First received: March 19, 2013
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
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
Other: Comfort Default AD forms
Other: Life Extension Default AD forms
Other: Standard Default AD forms

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Default Options in Advance Directives for Veterans With Serious Illnesses: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Philadelphia Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Evaluate how the setting of defaults influences the proportion of Veterans selecting comfort-oriented plans of care in real ADs [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • To document feasibility of a study of Advance Directives in the Veteran population [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 99
Study Start Date: March 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Comfort Default
ADs with pre-selected defaults that focus on providing comfort at end-of-life.
Other: Comfort Default AD forms
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.
Experimental: Life Extension Default
ADs with pre-selected defaults that focus on extending life.
Other: Life Extension Default AD forms
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.
Experimental: Standard Default
ADs without pre-selected defaults.
Other: Standard Default AD forms
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817686

Contacts
Contact: Joshua B Kayser, MD, MPH 215-823-5800 ext 5282 joshua.kayser@va.gov

Locations
United States, Pennsylvania
Philadelphia Veterans Affairs Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joshua B Kayser, MD, MPH    215-823-5800 ext 5282    joshua.kayser@va.gov   
Contact: Ashley E Kraybill, BA    215-823-5800 ext 3945    ashley.kraybill@va.gov   
Principal Investigator: Joshua B Kayser, MD, MPH         
Sponsors and Collaborators
Philadelphia Veterans Affairs Medical Center
Investigators
Principal Investigator: Joshua B Kayser, MD, MPH Philadelphia Veterans Affairs Medical Center
  More Information

No publications provided

Responsible Party: Joshua B. Kayser, Assistant Professor of Clinical Medicine, Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01817686     History of Changes
Other Study ID Numbers: 01381
Study First Received: March 19, 2013
Last Updated: March 21, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heart Failure
Idiopathic Pulmonary Fibrosis
Lung Diseases
Lung Diseases, Interstitial
Pulmonary Fibrosis
Cardiovascular Diseases
Heart Diseases
Idiopathic Interstitial Pneumonias
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 24, 2014