A Trial to Reduce Delirium in Aged Post Acute Patients
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Delirium Aging |
Behavioral: Delirium Abatement Program |
Phase 3 |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 500 |
| 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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Massachusetts | |
| Hebrew Rehabilitation Center for Aged | |
| Boston, Massachusetts, United States, 02131 | |
| Principal Investigator: | Edward Marcantonio, MD, SM | Beth Israel Deaconess Medical Center |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00182936 History of Changes |
| Other Study ID Numbers: | AG0040, AG17649 |
| Study First Received: | September 13, 2005 |
| Last Updated: | November 16, 2006 |
| Health Authority: | United States: Federal Government |
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:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013