NCT01505257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
391

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

3.8 years

First QC Date

January 4, 2012

Last Update Submit

October 25, 2017

Conditions

Delirium Superimposed on Dementia

Keywords

DeliriumDementiaConfusion Assessment Method

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

END-DSD Intervention

EXPERIMENTAL
Behavioral: END-DSD

Control

NO INTERVENTION

Interventions

END-DSDBEHAVIORAL

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

END-DSD Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Nittany Medical Center

State College, Pennsylvania, 16801, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

DeliriumDementia

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Donna Fick, RN,PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

  • Lorraine Mion, RN,PhD

    Vanderbilt University

    STUDY CHAIR

  • Jane McDowell, MSN

    Penn State University

    STUDY DIRECTOR

  • Sharon Inouye, MD, MPH

    Harvard University

    STUDY CHAIR

  • Ann Kolanowski, RN,PhD,FAAN

    Penn State University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, RN, FGSA, FAAN

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 6, 2012

Study Start

April 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2015

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

US(2)