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

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.

Study Overview

• Status: Completed
• Conditions: Delirium Superimposed on Dementia
• Intervention / Treatment: Behavioral: END-DSD

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 Type: Interventional
• Enrollment (Actual): 391
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Mount Nittany Medical Center
  • Tennessee
    • Nashville, Tennessee, United States
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Delirium	Measured using the Delirium Rating Scale R-98.	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	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	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)	Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: Vanderbilt University Medical Center; Augusta University; Harvard 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

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: January 4, 2012
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (ESTIMATE): January 6, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Dementia; Delirium; Confusion Assessment Method
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Dementia
• Other Study ID Numbers: R01NR011042 (NIH)