A Trial to Reduce Delirium in Aged Post Acute Patients

Phase 3

Completed

• Conditions: Delirium; Aging

• Registration Number: NCT00182936
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2000-05
• Study Completion: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2006-11
• Last Update Submitted: 2006-11-16
• Last Update Posted: 2006-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hebrew Rehabilitation Center for Aged; 🇺🇸 Boston, Massachusetts, United States