Study of Default Options in Advance Directives

Not Applicable

Completed

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

• Registration Number: NCT01817686
• Lead Sponsor: Corporal Michael J. Crescenz VA Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-25
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comfort Default	Comfort Default AD forms	ADs with pre-selected defaults that focus on providing comfort at end-of-life.
Standard Default	Standard Default AD forms	ADs without pre-selected defaults.
Life Extension Default	Life Extension Default AD forms	ADs with pre-selected defaults that focus on extending life.

Primary Outcome Measures

Name	Time	Method
Evaluate how the setting of defaults influences the proportion of Veterans selecting comfort-oriented plans of care in real ADs	18 months	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

Name	Time	Method
Assess the influence of default options in ADs on Veterans' selections of specific life-extending therapies	18 months	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	18 months	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

Trial Locations

Locations (1)

Philadelphia Veterans Affairs Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States