Study of Default Options in Advance Directives

Default Options in Advance Directives for Veterans With Serious Illnesses: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis; COPD; Congestive Heart Failure; Malignancy; Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy; Other Interstitial Lung Disease Without Curative Therapy; NYHA Class IV or NYHA Class III Plus 1 Hospitalization in the Past Year; Any Stage 3B or 4 Solid Tumor
• Intervention / Treatment: Other: Comfort Default AD forms; Other: Life Extension Default AD forms; Other: Standard Default AD forms

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia Veterans Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months
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	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To document feasibility of a study of Advance Directives in the Veteran population	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).	18 months

Collaborators and Investigators

• Sponsor: Corporal Michael J. Crescenz VA Medical Center
• Investigators: Principal Investigator: Joshua B Kayser, MD, MPH, Corporal Michael J. Crescenz VA Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimate): March 25, 2013

Study Record Updates

• Last Update Posted (Estimate): June 30, 2015
• Last Update Submitted That Met QC Criteria: June 29, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Heart Failure; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: 01381