A Trial to Reduce Delirium in Aged Post Acute Patients

This study has been completed.
Sponsor:
Collaborator:
Paul B. Beeson Career Development Awards in Aging Research Program
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00182936
First received: September 13, 2005
Last updated: November 16, 2006
Last verified: November 2006

September 13, 2005
November 16, 2006
May 2000
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00182936 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Trial to Reduce Delirium in Aged Post Acute Patients
A Trial to Reduce Delirium in Aged Post Acute Patients

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Delirium
  • Aging
Behavioral: Delirium Abatement Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
June 2004
Not Provided

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00182936
AG0040, AG17649
Not Provided
Not Provided
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
National Institute on Aging (NIA)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP