Study of Default Options in Advance Directives

Corporal Michael J. Crescenz VA Medical Center

Status: Completed

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

Treatments: Other: Comfort Default AD forms; Other: Life Extension Default AD forms; Other: Standard Default AD forms

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01817686

01381

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 3 patient groups

Comfort Default

Experimental group

Description:

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

Treatment:

Other: Comfort Default AD forms

Life Extension Default

Experimental group

Description:

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

Treatment:

Other: Life Extension Default AD forms

Standard Default

Experimental group

Description:

ADs without pre-selected defaults.

Treatment:

Other: Standard Default AD forms