NCT02801851

Brief Summary

This study will refine and pilot test an innovative, emergency department (ED)-based intervention for delirium screening, initial management, and communication with inpatient providers, and examine the impact of this intervention on the rate of documentation of delirium in the electronic health record by ED and inpatient providers. To achieve this, the study will develop and pilot test an intervention, Delirium Screening (SCREEN-ED) in the ED, involving 300 older patients (150 newly enrolled intervention participants, 150 historical controls (comparison group) currently being collected), that has 4 key components: systematic screening for delirium using the Confusion Assessment Method (CAM), informing providers of the screening result, a checklist protocol for initial delirium management based on clinical guidelines, and documentation in the Electronic Health Record (EHR) and communication with inpatient providers of delirium screening results. The study has two primary aims. The first is to refine and test the feasibility and acceptability of the SCREEN-ED intervention. The second is to examine the impact of SCREEN-ED on rate of delirium documentation and secondary outcomes (length of hospital stay, repeat ED visits and hospitalizations and mortality over 6-months) in the 150 newly enrolled intervention group compared with 150 already collected historical controls.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 19, 2016

Status Verified

June 1, 2016

Enrollment Period

1.7 years

First QC Date

March 29, 2016

Last Update Submit

July 18, 2016

Conditions

Delirium

Keywords

Delirium

Outcome Measures

Primary Outcomes (1)

  • Count of Delirium Diagnoses in EHR

    Count of delirium diagnoses in the EHR of study subjects

    6 months

Secondary Outcomes (5)

  • Count of Hospitalizations in participants

    6 months

  • Focus group content analysis for SCREEN-ED intervention feasibility

    months 4-16

  • Count of ED visits in participants

    6 months

  • Length of hospital stay in days in participants

    6 months

  • Mortality

    6 months

Study Arms (1)

Intervention SCREEN-ED

EXPERIMENTAL

This is the arm that will receive the SCREEN-ED. SCREEN-ED is an innovative, yet practical intervention that combines screening with informing clinicians of the results and provides a checklist for delirium management that is tailored to the time-limited ED setting.

Behavioral: SCREEN-ED

Interventions

SCREEN-EDBEHAVIORAL

SCREEN-ED will have 4 key components: systematic screening for delirium using the CAM; informing providers of the screening result; a checklist protocol for initial delirium management based on clinical guidelines tailored to the ED, which includes identification of cause, risk factor modification, and behavioral interventions; documentation in the Electronic Health Record (EHR) and communication with inpatient providers of delirium screening results.

Intervention SCREEN-ED

Eligibility Criteria

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

You may qualify if:

  • years presenting to the ED between 2pm and 11pm (highest ED census) 7 days a week

You may not qualify if:

  • Patients who are being evaluated for severe head injury and those who present with delirium tremens due to the difficulty of distinguishing delirium from head injury and because delirium tremens has a distinct etiology, course and outcomes.
  • Patients who are aphasic, comatose, terminally ill, deaf, or are non-English speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

Related Publications (6)

  • Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.

    PMID: 23992774BACKGROUND

  • Elie M, Rousseau F, Cole M, Primeau F, McCusker J, Bellavance F. Prevalence and detection of delirium in elderly emergency department patients. CMAJ. 2000 Oct 17;163(8):977-81.

    PMID: 11068569BACKGROUND

  • Hustey FM, Meldon SW. The prevalence and documentation of impaired mental status in elderly emergency department patients. Ann Emerg Med. 2002 Mar;39(3):248-53. doi: 10.1067/mem.2002.122057.

    PMID: 11867976BACKGROUND

  • Kakuma R, du Fort GG, Arsenault L, Perrault A, Platt RW, Monette J, Moride Y, Wolfson C. Delirium in older emergency department patients discharged home: effect on survival. J Am Geriatr Soc. 2003 Apr;51(4):443-50. doi: 10.1046/j.1532-5415.2003.51151.x.

    PMID: 12657062BACKGROUND

  • Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.

    PMID: 10053175BACKGROUND

  • Wei LA, Fearing MA, Sternberg EJ, Inouye SK. The Confusion Assessment Method: a systematic review of current usage. J Am Geriatr Soc. 2008 May;56(5):823-30. doi: 10.1111/j.1532-5415.2008.01674.x. Epub 2008 Apr 1.

    PMID: 18384586BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Jane Saczynski, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Saczynski, PhD

CONTACT

617-373-5212j.saczynski@neu.edu

Chad Darling, MD

CONTACT

508-421-1400chad.darling@umassmed.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

June 16, 2016

Study Start

July 1, 2015

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

July 19, 2016

Record last verified: 2016-06

Locations

US(1)