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DementiaNCT00121004

A Study to Tailor Advance Directives

An observational study of Dementia and Persistent Vegetative State, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Advance Directive Selection
How many people
100 participants
Where
1 siteUnited States
Study dates
Jul 2005to Sep 2005
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

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

Read the 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.

Being tested
Advance Directive Selection
Keywords
Advance Directive, Living Will, Terminal Illness
Medical subject headings
Dementia, Persistent Vegetative State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advance Directive SelectionBehavioural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionSep 2005
  4. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121004
Sponsor's protocol ID
13787A
Status last verified
Sep 2013
First submitted
11 Jul 2005
Last updated
5 Sep 2013
Results posted
No
Data monitoring committee
No

Publications

  • A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8.

    PubMed 7474243

  • Teno JM, Licks S, Lynn J, Wenger N, Connors AF Jr, Phillips RS, O'Connor MA, Murphy DP, Fulkerson WJ, Desbiens N, Knaus WA. Do advance directives provide instructions that direct care? SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment. J Am Geriatr Soc. 1997 Apr;45(4):508-12. doi: 10.1111/j.1532-5415.1997.tb05179.x.

    PubMed 9100722

  • Teno JM, Lynn J, Phillips RS, Murphy D, Youngner SJ, Bellamy P, Connors AF Jr, Desbiens NA, Fulkerson W, Knaus WA. Do formal advance directives affect resuscitation decisions and the use of resources for seriously ill patients? SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. J Clin Ethics. 1994 Spring;5(1):23-30. No abstract available.

    PubMed 8003719

  • Danis M, Southerland LI, Garrett JM, Smith JL, Hielema F, Pickard CG, Egner DM, Patrick DL. A prospective study of advance directives for life-sustaining care. N Engl J Med. 1991 Mar 28;324(13):882-8. doi: 10.1056/NEJM199103283241304.

    PubMed 2000110

  • Schneiderman LJ, Kronick R, Kaplan RM, Anderson JP, Langer RD. Effects of offering advance directives on medical treatments and costs. Ann Intern Med. 1992 Oct 1;117(7):599-606. doi: 10.7326/0003-4819-117-7-599.

    PubMed 1524334

  • Ditto PH, Danks JH, Smucker WD, Bookwala J, Coppola KM, Dresser R, Fagerlin A, Gready RM, Houts RM, Lockhart LK, Zyzanski S. Advance directives as acts of communication: a randomized controlled trial. Arch Intern Med. 2001 Feb 12;161(3):421-30. doi: 10.1001/archinte.161.3.421.

    PubMed 11176768

  • Fagerlin A, Schneider CE. Enough. The failure of the living will. Hastings Cent Rep. 2004 Mar-Apr;34(2):30-42.

    PubMed 15156835

  • Miles SH, Koepp R, Weber EP. Advance end-of-life treatment planning. A research review. Arch Intern Med. 1996 May 27;156(10):1062-8.

    PubMed 8638992

  • Teno JM. Advance directives: time to move on. Ann Intern Med. 2004 Jul 20;141(2):159-60. doi: 10.7326/0003-4819-141-2-200407200-00017. No abstract available.

    PubMed 15262674

  • Lunney JR, Lynn J, Hogan C. Profiles of older medicare decedents. J Am Geriatr Soc. 2002 Jun;50(6):1108-12. doi: 10.1046/j.1532-5415.2002.50268.x.

    PubMed 12110073

  • Fried TR, Bradley EH, Towle VR, Allore H. Understanding the treatment preferences of seriously ill patients. N Engl J Med. 2002 Apr 4;346(14):1061-6. doi: 10.1056/NEJMsa012528.

    PubMed 11932474

  • Danis M, Patrick DL, Southerland LI, Green ML. Patients' and families' preferences for medical intensive care. JAMA. 1988 Aug 12;260(6):797-802.

    PubMed 3392810

  • Starr TJ, Pearlman RA, Uhlmann RF. Quality of life and resuscitation decisions in elderly patients. J Gen Intern Med. 1986 Nov-Dec;1(6):373-9. doi: 10.1007/BF02596420.

    PubMed 3794836

  • Silverstein MD, Stocking CB, Antel JP, Beckwith J, Roos RP, Siegler M. Amyotrophic lateral sclerosis and life-sustaining therapy: patients' desires for information, participation in decision making, and life-sustaining therapy. Mayo Clin Proc. 1991 Sep;66(9):906-13. doi: 10.1016/s0025-6196(12)61577-8.

    PubMed 1921500

  • Murphy DJ, Santilli S. Elderly patients' preferences for long-term life support. Arch Fam Med. 1998 Sep-Oct;7(5):484-8. doi: 10.1001/archfami.7.5.484.

    PubMed 9755744

Questions about this trial

What is this clinical trial studying?

An observational study of Dementia and Persistent Vegetative State, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00121004, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.

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