Delirium Superimposed on DementiaEND-DSDNCT01505257
Early Nurse Detection and Management of Delirium
A study testing END-DSD in people with Delirium Superimposed on Dementia, run by Penn State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium Superimposed on Dementia
- What is being tested?
- END-DSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt University Medical Center
Nashville, Tennessee
Mount Nittany Medical Center
State College, Pennsylvania, 16801
About this study
Official title: Early Nurse Detection of Delirium Superimposed on Dementia
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.
Read the 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.
- Conditions
- Delirium Superimposed on Dementia
- Being tested
- END-DSD
- Keywords
- Delirium, Dementia, Confusion Assessment Method
- Medical subject headings
- Delirium, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
END-DSDBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| END-DSD Intervention | Experimental | Not described Receives: Behavioral: END-DSD |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Delirium
Measured using the Delirium Rating Scale R-98.
Measured: Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days
Inappropriate CNS-Active Medication Use
Ascertained from patient's medical record
Measured: Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days
Nurse Detection of Delirium
Ascertained through electronic health record and chart review
Measured: Participants will be assessed every shift until discharge (duration of hospitalization), which is expected to be about 5 days
Delirium Duration
Measured using the Confusion Assessment Method (CAM)
Measured: Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startApr 2010
- Primary completionFeb 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium Superimposed on DementiaStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, Harvard University, Augusta University
- Responsible party
- Principal investigator, Donna Fick, Penn State University
- Investigators
- Donna Fick, RN,PhD, Principal investigator, Penn State UniversityLorraine Mion, RN,PhD, Study chair, Vanderbilt UniversityJane McDowell, MSN, Study director, Penn State UniversitySharon Inouye, MD, MPH, Study chair, Harvard UniversityAnn Kolanowski, RN,PhD,FAAN, Study chair, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505257
- Sponsor's protocol ID
- R01NR011042
- Acronym
- END-DSD
- Status last verified
- Oct 2017
- First submitted
- 4 Jan 2012
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Nurse Detection of Delirium Superimposed on Dementia
- ClinicalTrials.gov ID
- NCT01505257
- Acronym / sponsor ID
- END-DSD / R01NR011042
- Conditions
- Delirium Superimposed on Dementia
- Keywords
- Delirium, Dementia, Confusion Assessment Method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, Harvard University, Augusta University
- Study start
- Apr 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| END-DSD Intervention | Experimental | Behavioral: END-DSD |
| Control | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (14 listed)
- 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:
- Nonverbal and unable to communicate due to severe dementia (MMSE=0)
- Aphasia
- Intubation
- Terminal illness (since interviews are required for the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| END-DSDMulti-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 | Behavioural | END-DSD Intervention |
Primary outcome
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.
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
Related trials for Delirium Superimposed on Dementia
Recruiting
Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation
Delirium, Delirium in Old Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Fick, RN,PhD principal investigator
Penn State University
Lorraine Mion, RN,PhD study chair
Vanderbilt University
Jane McDowell, MSN study director
Penn State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing END-DSD in people with Delirium Superimposed on Dementia, run by Penn State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Delirium (time frame: Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.