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


N/A
18 Years
N/A
Open (Enrolling)
Both
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

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Outcome Measure:

Evaluate how the setting of defaults influences the proportion of Veterans selecting comfort-oriented plans of care in real ADs

Outcome Description:

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.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Joshua B Kayser, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Philadelphia Veterans Affairs Medical Center

Authority:

United States: Federal Government

Study ID:

01381

NCT ID:

NCT01817686

Start Date:

March 2013

Completion Date:

September 2014

Related Keywords:

  • 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
  • Neoplasms
  • Fibrosis
  • Heart Failure
  • Lung Diseases
  • Pulmonary Fibrosis
  • Lung Diseases, Interstitial
  • Idiopathic Pulmonary Fibrosis

Name

Location
Philadelphia Veterans Affairs Medical Center Philadelphia, Pennsylvania  19104