A Trial to Reduce Delirium in Aged Post Acute Patients
Primary Purpose
Delirium, Aging
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Delirium Abatement Program
Sponsored by
About this trial
This is an interventional treatment trial for Delirium focused on measuring Cognition disorder, organic brain syndrome, patient care management, long term care, extended care facility
Eligibility Criteria
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
Sites / Locations
- Hebrew Rehabilitation Center for Aged
Outcomes
Primary Outcome Measures
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 Outcome Measures
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
Full Information
NCT ID
NCT00182936
First Posted
September 13, 2005
Last Updated
November 16, 2006
Sponsor
National Institute on Aging (NIA)
Collaborators
Paul B. Beeson Career Development Awards in Aging Research Program
1. Study Identification
Unique Protocol Identification Number
NCT00182936
Brief Title
A Trial to Reduce Delirium in Aged Post Acute Patients
Official Title
A Trial to Reduce Delirium in Aged Post Acute Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Aging (NIA)
Collaborators
Paul B. Beeson Career Development Awards in Aging Research Program
4. Oversight
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Aging
Keywords
Cognition disorder, organic brain syndrome, patient care management, long term care, extended care facility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Delirium Abatement Program
Primary Outcome Measure Information:
Title
Prevalence of delirium at two weeks after admission
Title
Activities of Daily Living (ADL) functional improvement two weeks after admission
Title
Full ADL functional recovery to pre-illness status three months after post-acute admission
Secondary Outcome Measure Information:
Title
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
Title
Differences in delirium severity, length of post acute stay, and health care resource utilization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Marcantonio, MD, SM
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebrew Rehabilitation Center for Aged
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2644535
Citation
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.
Results Reference
background
PubMed Identifier
10855596
Citation
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.
Results Reference
background
PubMed Identifier
1739363
Citation
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.
Results Reference
background
PubMed Identifier
12534838
Citation
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.
Results Reference
result
PubMed Identifier
15935018
Citation
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.
Results Reference
result
PubMed Identifier
16979083
Citation
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.
Results Reference
result
PubMed Identifier
16181185
Citation
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.
Results Reference
result
PubMed Identifier
20487083
Citation
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.
Results Reference
derived
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A Trial to Reduce Delirium in Aged Post Acute Patients
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