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Completed

NCT Number: NCT01505257

Early Nurse Detection and Management of Delirium

Delirium (acute confusion) is common and costly in persons with dementia, resulting in longer hospital stays, more complications, and greater functional decline. This research tests the use of the electronic health record, education, and regular feedback to nurses to improve detection and management of delirium. Ultimately, findings will direct ways to improve acute care of this vulnerable population.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Nittany Medical Center, State College, Pennsylvania, United States

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About this study

Delirium is an acute, reversible change in mental status that occurs in over 40% of persons with dementia. Delirium superimposed on dementia (DSD) leads to increased mortality, increased costs, nursing home placement, early re-hospitalization, and functional decline. Delirium in persons with dementia appears to substantially worsen outcomes in persons with dementia- who are already burdened with functional decline. The purpose of this study is to improve nursing detection and management of delirium in persons with dementia and decrease the duration and patient complications of delirium. To achieve these objectives, a multi-component intervention strategy called, Early Nurse Detection of Delirium Superimposed on Dementia (END DSD) will be tested. END-DSD employs a paired cluster randomized trial (C-RCT) of three hospitals with a total of six inpatient units and 360 hospitalized persons with dementia to achieve these objectives. END DSD intervention consists of 1) Nursing education regarding DSD, 2) Computerized decision support through standardized delirium assessment and management screens via the electronic health record (EHR), 3) an identified unit champion on each intervention unit who will be utilized to persuade other nurses to implement the innovation, and 4) Weekly feedback to the nursing staff to further facilitate assessment and management of delirium. We are testing the following specific aims: A.1: To determine whether the intervention "END DSD" improves nurse detection and management of DSD. A.2: To determine the effect of "END DSD" intervention on patient clinical outcomes, including duration of delirium and rate of psychoactive medications.

The study focuses on a costly and prevalent problem, and utilizes a novel approach that via the EHR will clearly be replicable across settings of care. END-DSD has the potential to significantly improve quality of life and decrease costs of care by: improving the detection of DSD; increasing the use of non-pharmacological management of DSD; shortening the duration of delirium and hospital length of stay; and decreasing the use of inappropriate medications, thus mitigating the complications of DSD. This project builds on over a decade of funded research and clinical practice by the investigators, and brings their unique and collaborative efforts together in an innovative manner to impact the under addressed problem of DSD in hospitalized older adults.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Persons with dementia will be included if they: a) are on one of the selected medical-surgical units and are age 65 years or older; b) have been hospitalized less than 48 hours; and c) meet the criteria for dementia. The study will include minorities and women.

Exclusion criteria

  • Persons with dementia will be excluded if they have any significant neurological or neurosurgical disease associated with cognitive impairment other than dementia (due to confounding with dementia or DSD), such as:
  • Lewy Body Dementia
  • Huntington's disease
  • Sormal pressure hydrocephalus
  • Seizure disorder
  • Subdural hematoma
  • Head trauma
  • Known structural brain abnormalities
  • Nonverbal and unable to communicate due to severe dementia (MMSE=0)
  • Aphasia
  • Intubation
  • Terminal illness (since interviews are required for the study).
  • This study will not exclude persons with pre-existing delirium.
  • In addition, subjects will not be excluded on the basis of race or gender.

Treatment and study plan

END-DSD

Behavioral

Multi-component intervention including 1) Nursing education regarding detection and management of delirium superimposed on dementia; 2) Computerized decision support and EHR; 3) A unit champion nurse for promotion of delirium assessment and management; 4) Feedback to nursing staff

Primary outcomes

  1. Severity of Delirium

    Time frame: Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days

    Measured using the Delirium Rating Scale R-98.

  2. Inappropriate CNS-Active Medication Use

    Time frame: Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days

    Ascertained from patient's medical record

  3. Nurse Detection of Delirium

    Time frame: Participants will be assessed every shift until discharge (duration of hospitalization), which is expected to be about 5 days

    Ascertained through electronic health record and chart review

  4. Delirium Duration

    Time frame: Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days

    Measured using the Confusion Assessment Method (CAM)

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Augusta University
  • Harvard University
  • Vanderbilt University Medical Center

Registry information

Official study title

Early Nurse Detection of Delirium Superimposed on Dementia

Acronym: END-DSD

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Jan 6, 2012
Registry last updated
Oct 26, 2017

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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