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Completed

NCT Number: NCT00182936

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hebrew Rehabilitation Center for Aged

Boston, Massachusetts, 02131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delirium Abatement Program

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Collaborators

  • Paul B. Beeson Career Development Awards in Aging Research Program

Registry information

Important dates

Study start
2000
Study completion
2004
First posted
Sep 16, 2005
Registry last updated
Nov 20, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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