NCT00182936

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2000

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

November 20, 2006

Status Verified

November 1, 2006

First QC Date

September 13, 2005

Last Update Submit

November 16, 2006

Conditions

DeliriumAging

Keywords

Cognition disorderorganic brain syndromepatient care managementlong term careextended care facility

Outcome Measures

Primary Outcomes (3)

  • Prevalence of delirium at two weeks after admission

  • Activities of Daily Living (ADL) functional improvement two weeks after admission

  • Full ADL functional recovery to pre-illness status three months after post-acute admission

Secondary Outcomes (2)

  • Examination of differences between patients in facilities receiving the Delirium Abatement Program and those not on additional outcomes of delirium persistence and ADL improvement one month following admission

  • Differences in delirium severity, length of post acute stay, and health care resource utilization

Interventions

Delirium Abatement ProgramBEHAVIORAL

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant hearing impairment which precludes interviews
  • End stage dementia (complete ADL dependence)
  • Previous study enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew Rehabilitation Center for Aged

Boston, Massachusetts, 02131, United States

Location

Related Publications (8)

  • 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.

    PMID: 2644535BACKGROUND

  • 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.

    PMID: 10855596BACKGROUND

  • 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.

    PMID: 1739363BACKGROUND

  • 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.

    PMID: 12534838RESULT

  • 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.

    PMID: 15935018RESULT

  • 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.

    PMID: 16979083RESULT

  • 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.

    PMID: 16181185RESULT

  • 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.

    PMID: 20487083DERIVED

MeSH Terms

Conditions

DeliriumCognition Disorders

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Edward Marcantonio, MD, SM

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

May 1, 2000

Study Completion

June 1, 2004

Last Updated

November 20, 2006

Record last verified: 2006-11

Locations

US(1)