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Completed

NCT Number: NCT01817686

Study of Default Options in Advance Directives

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.

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Key information

Conditions

COPD Any Stage 3B or 4 Solid Tumor Cardiovascular Diseases Chronic Disease Congestive Heart Failure Disease Attributes Heart Diseases Heart Failure Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Malignancy NYHA Class IV or NYHA Class III Plus 1 Hospitalization in the Past Year Neoplasms Other Interstitial Lung Disease Without Curative Therapy Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Respiratory Tract Diseases Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philadelphia Veterans Affairs Medical Center

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comfort Default AD forms

Other

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.

Life Extension Default AD forms

Other

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.

Standard Default AD forms

Other

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Assess the influence of default options in ADs on Veterans' selections of specific life-extending therapies

    Time frame: 18 months

    The proportions of patients electing to receive each of the 5 specific life-extending interventions

  2. Determine whether setting defaults in ADs influences the proportion of time during follow-up that Veterans spend in the hospital or ICU

    Time frame: 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

Other outcomes

  1. To document feasibility of a study of Advance Directives in the Veteran population

    Time frame: 18 months

    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).

Sponsors and collaborators

Lead sponsor

Corporal Michael J. Crescenz VA Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 25, 2013
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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