Early Nurse Detection and Management of Delirium (END-DSD)
Primary Purpose
Delirium Superimposed on Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
END-DSD
Sponsored by
About this trial
This is an interventional prevention trial for Delirium Superimposed on Dementia focused on measuring Delirium, Dementia, Confusion Assessment Method
Eligibility 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.
Sites / Locations
- Mount Nittany Medical Center
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
END-DSD Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Severity of Delirium
Measured using the Delirium Rating Scale R-98.
Inappropriate CNS-Active Medication Use
Ascertained from patient's medical record
Nurse Detection of Delirium
Ascertained through electronic health record and chart review
Delirium Duration
Measured using the Confusion Assessment Method (CAM)
Secondary Outcome Measures
Full Information
NCT ID
NCT01505257
First Posted
January 4, 2012
Last Updated
October 25, 2017
Sponsor
Penn State University
Collaborators
Vanderbilt University Medical Center, Harvard University, Augusta University
1. Study Identification
Unique Protocol Identification Number
NCT01505257
Brief Title
Early Nurse Detection and Management of Delirium
Acronym
END-DSD
Official Title
Early Nurse Detection of Delirium Superimposed on Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
Vanderbilt University Medical Center, Harvard University, Augusta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium Superimposed on Dementia
Keywords
Delirium, Dementia, Confusion Assessment Method
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
391 (Actual)
8. Arms, Groups, and Interventions
Arm Title
END-DSD Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
END-DSD
Intervention Description
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 Outcome Measure Information:
Title
Severity of Delirium
Description
Measured using the Delirium Rating Scale R-98.
Time Frame
Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days
Title
Inappropriate CNS-Active Medication Use
Description
Ascertained from patient's medical record
Time Frame
Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days
Title
Nurse Detection of Delirium
Description
Ascertained through electronic health record and chart review
Time Frame
Participants will be assessed every shift until discharge (duration of hospitalization), which is expected to be about 5 days
Title
Delirium Duration
Description
Measured using the Confusion Assessment Method (CAM)
Time Frame
Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Fick, RN,PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lorraine Mion, RN,PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jane McDowell, MSN
Organizational Affiliation
Penn State University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sharon Inouye, MD, MPH
Organizational Affiliation
Harvard University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ann Kolanowski, RN,PhD,FAAN
Organizational Affiliation
Penn State University
Official's Role
Study Chair
Facility Information:
Facility Name
Mount Nittany Medical Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Nurse Detection and Management of Delirium
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