Clinical trial NCT04115371: A Randomized Controlled Trial of Geriatric Emergency Department Innovations
Official title: A Randomized Controlled Trial of Geriatric Emergency Department Innovations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 822
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Hospitalization is common for older adults in the Emergency Department (ED) but it carries significant risks including the development of delirium, falls, and nosocomial infections. The Geriatric Emergency Department Innovations (GEDI) program at Northwestern Memorial Hospital attempts to identify and address health related risks for older adults without exposing them to the risks of hospitalization,. GEDI is a unique program consisting of a multidisciplinary team of Transitional Care Nurses (TCN), social workers, pharmacists, occupational therapists and physical therapists who perform ED-based geriatric assessment and care coordination.

To determine the impact of GEDI on health services use and Health Related Quality-of-Life (HRQoL) we will conduct a randomized controlled trial comparing GEDI compared to usual ED care(which often involves hospitalization).

Eligibility criteria: Inclusion Criteria:

Northwestern Emergency Department patients who are:

* 65 years or older
* living independently or with friends, family, or caregivers in the community
* Clinical Frailty Scale (CFS) score of 4 or greater

Exclusion Criteria:

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

Primary outcomes:
measure: Number of patients with hospital admission or death
timeFrame: 30 days
Secondary outcomes:
measure: PROMIS-Preference
timeFrame: 9 days
measure: PROMIS-Preference
timeFrame: 30 days
measure: Return Emergency Department Visits
timeFrame: 9 days
measure: Return Emergency Department Visits
timeFrame: 30 days
measure: Death
timeFrame: 9 days
measure: Death
timeFrame: 30 days
measure: PROMIS Item Bank v2.0 - Physical Function (Adaptive)
timeFrame: 9 days
measure: PROMIS Item Bank v2.0 - Physical Function (Adaptive)
timeFrame: 30 days
measure: PROMIS Item Bank v2.0 - Ability to Participate Social Roles and Activities (Adaptive)
timeFrame: 9 days
measure: PROMIS Item Bank v2.0 - Ability to Participate Social (Adaptive)
timeFrame: 30 days
measure: PROMIS Item Bank v. 1.0 - Emotional Distress - Anxiety (Adaptive)
timeFrame: 9 days
measure: PROMIS Item Bank v. 1.0 - Emotional Distress - Anxiety (Adaptive)
timeFrame: 30 days
measure: PROMIS Item Bank v. 1.0 - Emotional Distress - Depression (Adaptive)
timeFrame: 9 days
measure: PROMIS Item Bank v. 1.0 - Emotional Distress - Depression (Adaptive)
timeFrame: 30 days
measure: Number of patients admitted
timeFrame: 24 hours
measure: Number of patients admitted
timeFrame: 9 days
measure: Number of patients admitted
timeFrame: 30 days
measure: Number of patients with hospital admission or death
timeFrame: 9 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Emergency Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Department of Emergency Medicine
name: Scott M Dresden, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.