A Study to Tailor Advance Directives

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00121004
First received: July 11, 2005
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 Intervention
Dementia
Persistent Vegetative State
Terminally Ill
Behavioral: Advance Directive Selection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Tailor Advance Directives

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Estimated Enrollment: 100
Study Start Date: July 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized patients admitted to the general medical service at the University of Chicago

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121004

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

Publications:
Fagerlin A, Schneider C. The failure of the living will. Hastings Cent Rep 2004;34:30-42.

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00121004     History of Changes
Other Study ID Numbers: 13787A
Study First Received: July 11, 2005
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 28, 2014