Clinical trial NCT01817686: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Corporal Michael J. Crescenz VA Medical Center
Sponsor class: FED
First posted: 2013-03-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Evaluate how the setting of defaults influences the proportion of Veterans selecting comfort-oriented plans of care in real ADs
timeFrame: 18 months
Secondary outcomes:
measure: Assess the influence of default options in ADs on Veterans' selections of specific life-extending therapies
timeFrame: 18 months
measure: Determine whether setting defaults in ADs influences the proportion of time during follow-up that Veterans spend in the hospital or ICU
timeFrame: 18 months
Other outcomes:
measure: To document feasibility of a study of Advance Directives in the Veteran population
timeFrame: 18 months
Locations:
city: Philadelphia
country: United States
facility: Philadelphia Veterans Affairs Medical Center
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center
name: Joshua B Kayser, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: