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Early Nurse Detection and Management of Delirium

NCT ID: NCT01505257

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

391 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Delirium Superimposed on Dementia

Keywords

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Delirium Dementia Confusion Assessment Method

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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END-DSD Intervention

Group Type EXPERIMENTAL

END-DSD

Intervention Type 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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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END-DSD

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Donna Fick

PhD, RN, FGSA, FAAN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donna Fick, RN,PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Lorraine Mion, RN,PhD

Role: STUDY_CHAIR

Vanderbilt University

Jane McDowell, MSN

Role: STUDY_DIRECTOR

Penn State University

Sharon Inouye, MD, MPH

Role: STUDY_CHAIR

Harvard University

Ann Kolanowski, RN,PhD,FAAN

Role: STUDY_CHAIR

Penn State University

Locations

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Mount Nittany Medical Center

State College, Pennsylvania, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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R01NR011042

Identifier Type: NIH

Identifier Source: org_study_id

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