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A Trial to Reduce Delirium in Aged Post Acute Patients

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ClinicalTrials.gov Identifier: NCT00182936
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : November 20, 2006
Paul B. Beeson Career Development Awards in Aging Research Program
Information provided by:
National Institute on Aging (NIA)

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.

Condition or disease Intervention/treatment Phase
Delirium Aging Behavioral: Delirium Abatement Program Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Trial to Reduce Delirium in Aged Post Acute Patients
Study Start Date : May 2000
Estimated Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Primary Outcome Measures :
  1. Prevalence of delirium at two weeks after admission
  2. Activities of Daily Living (ADL) functional improvement two weeks after admission
  3. Full ADL functional recovery to pre-illness status three months after post-acute admission

Secondary Outcome Measures :
  1. 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
  2. Differences in delirium severity, length of post acute stay, and health care resource utilization

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182936

United States, Massachusetts
Hebrew Rehabilitation Center for Aged
Boston, Massachusetts, United States, 02131
Sponsors and Collaborators
National Institute on Aging (NIA)
Paul B. Beeson Career Development Awards in Aging Research Program
Principal Investigator: Edward Marcantonio, MD, SM Beth Israel Deaconess Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00182936     History of Changes
Other Study ID Numbers: AG0040
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: November 20, 2006
Last Verified: November 2006

Keywords provided by National Institute on Aging (NIA):
Cognition disorder
organic brain syndrome
patient care management
long term care
extended care facility

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders