View Clinical Trial (Medical Research Study)
Early Nurse Detection of Delirium Superimposed on Dementia
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State College |
| State: |
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Pennsylvania |
| Zip Code: |
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16801 |
| Conditions: |
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Delirium Superimposed on Dementia |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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.
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| NCT ID: |
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NCT01505257 |
| Primary Contact: |
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Principal Investigator
Donna Fick, RN,PhD
Penn State University
Donna Fick, PhD, RN, FAAN
Phone: 814-865-9325
Email: dmf21@psu.edu
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| Backup Contact: |
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Email: jam94@psu.edu
Jane McDowell, MSN, APRN, GNP-BC
Phone: 814-865-4526
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| Location Contact: |
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State College, Pennsylvania 16801
United States
Donna Fick, PhD, RN, FGSA, FAAN
Phone: 814-865-9325
Email: dmf21@psu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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