NCT04115371

Brief Summary

This study evaluates the Geriatric Emergency Department Innovations (GEDI) program at Northwestern Memorial Hospital to care for older adults in the emergency department. Half of the patients will be cared for by a standard ED team plus the GEDI team, while half of the patients will receive usual ED care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
822

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

October 7, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

5.3 years

First QC Date

September 30, 2019

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients with hospital admission or death

    A composite measure of any hospitalizations or death during the index ED visit or within the follow up time frame

    30 days

Secondary Outcomes (18)

  • PROMIS-Preference

    9 days

  • PROMIS-Preference

    30 days

  • Return Emergency Department Visits

    9 days

  • Return Emergency Department Visits

    30 days

  • Death

    9 days

  • +13 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Standard emergency department care

Intervention

OTHER

Standard emergency department are plus GEDI consult

Behavioral: Intervention

Interventions

InterventionBEHAVIORAL

Geriatric assessment and care coordination provided by a multidisciplinary team in the emergency department including transitional care nurses, social workers, pharmacists, occupational therapists, and physical therapists.

Intervention

Eligibility Criteria

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

You may qualify if:

  • Northwestern Emergency Department patients who are:
  • years or older
  • living independently or with friends, family, or caregivers in the community
  • Clinical Frailty Scale (CFS) score of 4 or greater

You may not qualify if:

  • Patients will be excluded if they:
  • Tested positive for COVID-19
  • Are unable to complete the assessments in English
  • Are unable to provide informed consent with no Legally Authorized Representative Present or are unable to complete follow-up participation
  • Are held in the ED involuntarily as a prisoner or patient with a psychiatric complaint
  • Are enrolled in another study to avoid patient fatigue and confounding
  • Received a GEDI, Social Work, Pharmacy, or Physical Therapy consult outside of this trial during the current ED visit
  • Leave the ED against medical advice or without being seen by a physician
  • Are admitted to the ICU
  • Are too medically unstable to participate in the assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Department of Emergency Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Dresden SM, Lo AX, Lindquist LA, Kocherginsky M, Post LA, French DD, Gray E, Heinemann AW. The impact of Geriatric Emergency Department Innovations (GEDI) on health services use, health related quality of life, and costs: Protocol for a randomized controlled trial. Contemp Clin Trials. 2020 Oct;97:106125. doi: 10.1016/j.cct.2020.106125. Epub 2020 Aug 26.

MeSH Terms

Conditions

Frailty

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Scott M Dresden, MD, MS

    Northwestern University Department of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 4, 2019

Study Start

October 7, 2019

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The Galter Library at Northwestern University has implemented a DigitalHub to facilitate the storage and sharing of research products, including data sets, presentations, documentation, brochures, etc. The DigitalHub also provides digital object identifier so that these resources can be appropriately cited and tracked. Where feasible we will curate and make available structured data both as de-identified and limited datasets as defined under HIPAA. Interested collaborators will complete an online collaborative research request survey.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The data will be made available at the completion of the study and will be available for at least 5 years.
Access Criteria
Access will be determined by the DigitalHub requirements.
More information

Locations