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A Trial to Reduce Delirium in Aged Post Acute Patients

NCT ID: NCT00182936

Last Updated: 2006-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2004-06-30

Brief Summary

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The purpose of this study is to develop a comprehensive Delirium Abatement Program of care of delirious patients in the post acute care setting and to evaluate its impact on persistence and severity of delirium and on functional recovery.

Detailed Description

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Common, morbid, and costly, delirium affects one third of hospitalized elders, and plays a central role in the cascade of adverse events that leads to functional decline and loss of independence. Moreover, as acute care stays continue to shorten and evidence mounts that delirium may persist for many weeks, concern about delirium can no longer be confined to the hospital. It is believed that a Delirium Abatement Program may significantly reduce the persistence of delirium in post-acute settings, and thereby improve functional recovery both during the post-acute stay and after discharge.

The Delirium Abatement Program (DAP) will be designed to assist facility staff to 1) detect delirium among new admissions, 2) evaluate common underlying causes of delirium, 3) prevent complications commonly associated with delirium, and 4) restore delirious patients' cognitive, behavioral, social and self care functioning to baseline status.

This three year trial will enroll 500 delirious patients admitted to eight Boston area post-acute skilled nursing facilities. The DAP intervention will be carried out in four facilities. Four other facilities, matched to the intervention by demographic, facility, and clinical characteristics, will serve as controls. Patients will be recruited within 72 hours (maximum 120 hrs) of admission, assessed weekly while in the facility, and at one, three, and six months following admission.

Conditions

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Delirium Aging

Keywords

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Cognition disorder organic brain syndrome patient care management long term care extended care facility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Delirium Abatement Program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Admission to study site following acute care medical/surgical hospitalization
* Aged 65 or older
* English-speaking
* Communicative prior to acute illness
* Not admitted for terminal care (life expectancy greater than 6 months)
* Residence within 25 miles of research site

Exclusion Criteria

* Significant hearing impairment which precludes interviews
* End stage dementia (complete ADL dependence)
* Previous study enrollment
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paul B. Beeson Career Development Awards in Aging Research Program

UNKNOWN

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role lead

Principal Investigators

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Edward Marcantonio, MD, SM

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Hebrew Rehabilitation Center for Aged

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Lipowski ZJ. Delirium in the elderly patient. N Engl J Med. 1989 Mar 2;320(9):578-82. doi: 10.1056/NEJM198903023200907. No abstract available.

Reference Type BACKGROUND
PMID: 2644535 (View on PubMed)

Marcantonio ER, Flacker JM, Michaels M, Resnick NM. Delirium is independently associated with poor functional recovery after hip fracture. J Am Geriatr Soc. 2000 Jun;48(6):618-24. doi: 10.1111/j.1532-5415.2000.tb04718.x.

Reference Type BACKGROUND
PMID: 10855596 (View on PubMed)

Levkoff SE, Evans DA, Liptzin B, Cleary PD, Lipsitz LA, Wetle TT, Reilly CH, Pilgrim DM, Schor J, Rowe J. Delirium. The occurrence and persistence of symptoms among elderly hospitalized patients. Arch Intern Med. 1992 Feb;152(2):334-40. doi: 10.1001/archinte.152.2.334.

Reference Type BACKGROUND
PMID: 1739363 (View on PubMed)

Marcantonio ER, Simon SE, Bergmann MA, Jones RN, Murphy KM, Morris JN. Delirium symptoms in post-acute care: prevalent, persistent, and associated with poor functional recovery. J Am Geriatr Soc. 2003 Jan;51(1):4-9. doi: 10.1034/j.1601-5215.2002.51002.x.

Reference Type RESULT
PMID: 12534838 (View on PubMed)

Marcantonio ER, Kiely DK, Simon SE, John Orav E, Jones RN, Murphy KM, Bergmann MA. Outcomes of older people admitted to postacute facilities with delirium. J Am Geriatr Soc. 2005 Jun;53(6):963-9. doi: 10.1111/j.1532-5415.2005.53305.x.

Reference Type RESULT
PMID: 15935018 (View on PubMed)

Simon SE, Bergmann MA, Jones RN, Murphy KM, Orav EJ, Marcantonio ER. Reliability of a structured assessment for nonclinicians to detect delirium among new admissions to postacute care. J Am Med Dir Assoc. 2006 Sep;7(7):412-5. doi: 10.1016/j.jamda.2006.02.006. Epub 2006 May 30.

Reference Type RESULT
PMID: 16979083 (View on PubMed)

Bergmann MA, Murphy KM, Kiely DK, Jones RN, Marcantonio ER. A model for management of delirious postacute care patients. J Am Geriatr Soc. 2005 Oct;53(10):1817-25. doi: 10.1111/j.1532-5415.2005.53519.x.

Reference Type RESULT
PMID: 16181185 (View on PubMed)

Marcantonio ER, Bergmann MA, Kiely DK, Orav EJ, Jones RN. Randomized trial of a delirium abatement program for postacute skilled nursing facilities. J Am Geriatr Soc. 2010 Jun;58(6):1019-26. doi: 10.1111/j.1532-5415.2010.02871.x. Epub 2010 May 7.

Reference Type DERIVED
PMID: 20487083 (View on PubMed)

Other Identifiers

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AG17649

Identifier Type: -

Identifier Source: secondary_id

AG0040

Identifier Type: -

Identifier Source: org_study_id