Early Nurse Detection and Management of Delirium (END-DSD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Penn State University
Sponsor:
Collaborators:
Vanderbilt University
Harvard University
Georgia Regents University
Information provided by (Responsible Party):
Donna Fick, Penn State University
ClinicalTrials.gov Identifier:
NCT01505257
First received: January 4, 2012
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Delirium Superimposed on Dementia
Behavioral: END-DSD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Nurse Detection of Delirium Superimposed on Dementia

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Severity of Delirium [ Time Frame: Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days ] [ Designated as safety issue: No ]
    Measured using the Delirium Rating Scale R-98.

  • 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 ] [ Designated as safety issue: No ]
    Ascertained from patient's medical record

  • 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 ] [ Designated as safety issue: No ]
    Ascertained through electronic health record and chart review

  • Delirium Duration [ Time Frame: Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days ] [ Designated as safety issue: No ]
    Measured using the Confusion Assessment Method (CAM)


Estimated Enrollment: 390
Study Start Date: April 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: END-DSD Intervention Behavioral: 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
No Intervention: Control

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505257

Contacts
Contact: Donna Fick, PhD, RN, FAAN 814-865-9325 dmf21@psu.edu
Contact: Jane McDowell, MSN, APRN, GNP-BC 814-865-4526 jam94@psu.edu

Locations
United States, Pennsylvania
Mount Nittany Medical Center Recruiting
State College, Pennsylvania, United States, 16801
Contact: Donna Fick, PhD, RN, FGSA, FAAN    814-865-9325    dmf21@psu.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States
Contact: Lorraine Mion, PhD, RN, FAAN    615-343-7098    lorraine.c.mion@vanderbilt.edu   
Sponsors and Collaborators
Penn State University
Vanderbilt University
Harvard University
Georgia Regents University
Investigators
Principal Investigator: Donna Fick, RN,PhD Penn State University
Study Chair: Lorraine Mion, RN,PhD Vanderbilt University
Study Director: Jane McDowell, MSN Penn State University
Study Chair: Sharon Inouye, MD, MPH Harvard University
Study Chair: Ann Kolanowski, RN,PhD,FAAN Penn State University
  More Information

No publications provided

Responsible Party: Donna Fick, PhD, RN, FGSA, FAAN, Penn State University
ClinicalTrials.gov Identifier: NCT01505257     History of Changes
Other Study ID Numbers: R01NR011042
Study First Received: January 4, 2012
Last Updated: January 5, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Penn State University:
Delirium
Dementia
Confusion Assessment Method

Additional relevant MeSH terms:
Delirium
Dementia
Brain Diseases
Central Nervous System Diseases
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014