- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00121004
A Study to Tailor Advance Directives
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- The University of Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elmer Abbo, M.D., Ph.D., University of Chicago
- Principal Investigator: David Meltzer, M.D., Ph.D., University of Chicago
Publications and helpful links
General 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. Erratum In: JAMA 1996 Apr 24;275(16):1232.
- 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.
- 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.
- 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.
- 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.
- 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.
- Fagerlin A, Schneider CE. Enough. The failure of the living will. Hastings Cent Rep. 2004 Mar-Apr;34(2):30-42.
- 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.
- 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.
- 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.
- 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.
- Danis M, Patrick DL, Southerland LI, Green ML. Patients' and families' preferences for medical intensive care. JAMA. 1988 Aug 12;260(6):797-802.
- 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.
- 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.
- 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.
- Blackhall LJ, Frank G, Murphy ST, Michel V, Palmer JM, Azen SP. Ethnicity and attitudes towards life sustaining technology. Soc Sci Med. 1999 Jun;48(12):1779-89. doi: 10.1016/s0277-9536(99)00077-5.
- Gjerdingen DK, Neff JA, Wang M, Chaloner K. Older persons' opinions about life-sustaining procedures in the face of dementia. Arch Fam Med. 1999 Sep-Oct;8(5):421-5. doi: 10.1001/archfami.8.5.421.
- Robertson GS. Resuscitation and senility: a study of patients' opinions. J Med Ethics. 1993 Jun;19(2):104-7. doi: 10.1136/jme.19.2.104.
- Emanuel LL, Barry MJ, Stoeckle JD, Ettelson LM, Emanuel EJ. Advance directives for medical care--a case for greater use. N Engl J Med. 1991 Mar 28;324(13):889-95. doi: 10.1056/NEJM199103283241305.
- Lo B, McLeod GA, Saika G. Patient attitudes to discussing life-sustaining treatment. Arch Intern Med. 1986 Aug;146(8):1613-5. No abstract available.
- Singer PA, Thiel EC, Salit I, Flanagan W, Naylor CD. The HIV-specific advance directive. J Gen Intern Med. 1997 Dec;12(12):729-35. doi: 10.1046/j.1525-1497.1997.07157.x.
- Griffith CH 3rd, Wilson JF, Emmett KR, Ramsbottom-Lucier M, Rich EC. Knowledge and experience with Alzheimer's disease. Relationship to resuscitation preference. Arch Fam Med. 1995 Sep;4(9):780-4. doi: 10.1001/archfami.4.9.780.
- Everhart MA, Pearlman RA. Stability of patient preferences regarding life-sustaining treatments. Chest. 1990 Jan;97(1):159-64. doi: 10.1378/chest.97.1.159.
- Berger JT, Majerovitz D. Stability of preferences for treatment among nursing home residents. Gerontologist. 1998 Apr;38(2):217-23. doi: 10.1093/geront/38.2.217.
- Mitchell SL, Kiely DK, Hamel MB. Dying with advanced dementia in the nursing home. Arch Intern Med. 2004 Feb 9;164(3):321-6. doi: 10.1001/archinte.164.3.321.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13787A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden
Clinical Trials on Advance Directive Selection
-
University of PennsylvaniaCompletedThoracic Cancer | GI CancerUnited States
-
University of PennsylvaniaUniversity of PittsburghCompletedThis Study Will Focus on Advance Care Planning Among Patients With Life-limiting IllnessesUnited States
-
National Institute on Aging (NIA)PfizerCompleted
-
University of PennsylvaniaUniversity of PittsburghCompleted
-
University of California, Los AngelesUniversity of California, San Francisco; University of California, IrvineActive, not recruitingAdvanced Cancer | Advance Care Planning | Advance DirectivesUnited States
-
VA Office of Research and DevelopmentCompleted
-
Stanford UniversityRecruitingPalliative Care | Advance DirectivesUnited States
-
Stanford UniversityCompletedBone Marrow Transplant | Advance DirectivesUnited States
-
Centre Hospitalier Universitaire DijonCompleted
-
Hospices Civils de LyonCompleted