A Study to Tailor Advance Directives

Dementia Clinical Trial

Official title:

A Study to Tailor Advance Directives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121004
• Other study ID #: 13787A
• Status: Completed
• Phase: N/A
• First received: July 11, 2005
• Last updated: September 4, 2013
• Start date: July 2005
• Est. completion date: September 2005

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dementia
• Persistent Vegetative State
• Terminally Ill

Intervention

Behavioral:
• Advance Directive Selection

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references