Clinical Trial: Delirium Screening of the Elderly in the Emergency Department

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Delirium Screening of the Elderly in the Emergency Department

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.


Detailed Summary:

The investigators 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 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 short-term goal is to test the feasibility and acceptability of the intervention, and its immediate impact on documentation of delirium in the EHR. The long-term goal is to utilize the information gleaned from this developmental study to inform a large-scale multi-center randomized clinical trial to test the impact of the SCREEN-ED strategy on clinical outcomes including length of stay, repeat ED visits, rehospitalization, and mortality.

The study will enroll 150 patients to the intervention arm and will screen them for delirium using the CAM. The screening results (positive or negative) will be provided verbally and in the EHR to ED providers, and, in screen positive cases, ED physicians will be provided with a checklist protocol for delirium management that will be embedded in the ED EHR. Additionally, in admitted patients, the screening result will be entered into the inpatient EHR. The study team will review ED and inpatient medical records and compare physician documentation of delirium in SCREEN-ED compared with a historical comparison group currently being collected.

The study will follow all patients (intervention and comparison) through medical record review for 6 months to collect clinical outcomes, which will be examined as secondary
Sponsor: Northeastern University

Current Primary Outcome: Count of Delirium Diagnoses in EHR [ Time Frame: 6 months ]

Count of delirium diagnoses in the EHR of study subjects


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Count of Hospitalizations in participants [ Time Frame: 6 months ]
    Count of Hospitalizations in study subjects 6 months post-enrollment
  • Focus group content analysis for SCREEN-ED intervention feasibility [ Time Frame: months 4-16 ]
    Feasibility and acceptability of SCREEN-ED will be assessed from qualitative interviewers with providers as evaluated by REAIM (reach, effectiveness, adoption, implementation, maintenance) Framework which measures the acceptability, impact, and importance of an evaluation. This will be augmented by post-intervention focus group with 10 providers.
  • Count of ED visits in participants [ Time Frame: 6 months ]
    ED visits in the 6 months post-enrollment
  • Length of hospital stay in days in participants [ Time Frame: 6 months ]
    Length of hospital stays in days if hospitalized again in the 6 months post-enrollment
  • Mortality [ Time Frame: 6 months ]
    Mortality of participants in the 6 months post-enrollment


Original Secondary Outcome:

  • Count of Hospitalizations in participants [ Time Frame: 6 months ]
    Count of Hospitalizations in study subjects 6 months post-enrollment
  • Focus group content analysis for SCREEN-ED intervention feasibility [ Time Frame: months 4-16 ]
    Using qualitative methodology suggested by Miles and Huberman, feasibility and acceptability of SCREEN-ED will be assessed from qualitative interviewers with providers as evaluated by RE-AIM Framework which measures the acceptability, impact, and importance of an evaluation. This will be augmented by post-intervention focus group with 10 providers.
  • Count of ED visits in participants [ Time Frame: 6 months ]
    ED visits in the 6 months post-enrollement
  • Length of hospital stay in days in participants [ Time Frame: 6 months ]
    Length of hospital stays in days if hospitalized again in the 6 months post-enrollment
  • Mortality [ Time Frame: 6 months ]
    Mortality of participants in the 6 months post-enrollment


Information By: Northeastern University

Dates:
Date Received: March 29, 2016
Date Started: July 2015
Date Completion: June 2017
Last Updated: July 18, 2016
Last Verified: June 2016