A Study to Tailor Advance Directives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00121004
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : September 5, 2013
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
In this study, hospitalized patients will first be surveyed regarding their interest in a traditional advanced directive (AD) and then in a modified AD.

Condition or disease Intervention/treatment
Dementia Persistent Vegetative State Terminally Ill Behavioral: Advance Directive Selection

Detailed Description:

The purpose of this study is to assess whether patients will execute an advance directive which offers a limited trial of life-sustaining therapy in non-terminal illness, declines life-sustaining therapy or artificial nutrition in advanced dementia, or declines life-sustaining therapy in general. Advance directives (ADs) as currently drafted have been questioned since they have not had much effect on end-of-life care. However, the reason for the lack of success may be simply that they rarely apply. Traditional ADs, which are limited to terminal illness or persistent vegetative states, are difficult to apply to the more common cases of critical illness in the setting of potentially reversible disease and advanced dementia, which are often not recognized as terminal. In addition, terminal ADs are drafted too narrowly for patients who do not wish for life-sustaining therapy regardless of condition.

Patients may execute either AD at the conclusion of the survey. This research has the potential to demonstrate widely reproducible methods on which more precise advance planning can be based and thereby improve end-of-life care.

Study Type : Observational
Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Tailor Advance Directives
Study Start Date : July 2005
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients admitted to the general medical service at the University of Chicago

Inclusion Criteria:

  • Hospitalized patients admitted to the general medical service at the University of Chicago
  • Previously enrolled in a study of hospitalized general medicine patients at the University of Chicago

Exclusion Criteria:

  • Patients who score less than 17 out of 30 on the Folstein Mini-Mental Status Examination or who have a proxy decision-maker
  • Patients who are medically unstable based on two or more abnormal vital signs
  • Patients who face a possible new diagnosis of cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00121004

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Elmer Abbo, M.D., Ph.D. University of Chicago
Principal Investigator: David Meltzer, M.D., Ph.D. University of Chicago


Responsible Party: University of Chicago Identifier: NCT00121004     History of Changes
Other Study ID Numbers: 13787A
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by University of Chicago:
Advance Directive
Living Will
Terminal Illness

Additional relevant MeSH terms:
Persistent Vegetative State
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Brain Damage, Chronic
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms