Recruiting

SCREEN-ED

Sponsor:

Northeastern University

Code:

NCT02801851

Conditions

Delirium

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

SCREEN-ED

Study Details

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.

Conditions

Delirium

Study ID

NCT02801851

Start date

Jul, 2015

Status verified date

Jun, 2016

Completion date

Jun, 2017

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Intervention SCREEN-ED

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.

Interventions

SCREEN-ED

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.

Primary outcome measure

  • Count of Delirium Diagnoses in EHR [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jane Saczynski, PhD

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

Chad Darling, MD

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

Locations

UMass Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Principal Investigator:

Chad Darling, MD

More Information

Sponsor

Northeastern University

Last update posted

Jul 19, 2016

Last verified

Jun, 2016

Keywords

  • Delirium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northeastern University on 2016-07-19.