A Trial to Reduce Delirium in Aged Post Acute Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||A Trial to Reduce Delirium in Aged Post Acute Patients|
- 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
- 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
|Study Start Date:||May 2000|
|Estimated Study Completion Date:||June 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182936
|United States, Massachusetts|
|Hebrew Rehabilitation Center for Aged|
|Boston, Massachusetts, United States, 02131|
|Principal Investigator:||Edward Marcantonio, MD, SM||Beth Israel Deaconess Medical Center|