NCT04068311

Brief Summary

This project will implement a 2 step protocol for multidisciplinary geriatric assessment in the Emergency Department (ED). Candidate: Dr. Lauren Southerland is a Geriatric- and Emergency Medicine-trained physician at The Ohio State University Wexner Medical Center. Training: The career development plan will build upon Dr. Southerland's unique fellowship training in Geriatrics with courses in Implementation and Dissemination Science, a Black Belt in Lean Six Sigma, and Master's in Public Health courses. This combination will position her as an expert in Implementation research, with the career goal of translating validated, effective elements of geriatric care into the daily practice of Emergency Medicine. Mentors: Dr. Southerland has an experienced mentorship team who will provide guidance in the intricacies of emergency research (Dr. Jeffrey Caterino, MD, MPH), implementation strategies and studies of hospital staff and nurses (Dr. Lorraine Mion, PhD), implementation frameworks and reporting (Dr. Christopher Carpenter, an emergency medicine physician at Washington University at St. Louis), and identifying environmental and human factor barriers to quality care. Project: Multidisciplinary assessment by geriatricians, physical therapists, case managers, and pharmacists identifies and addresses underlying geriatric issues in older ED patients. However, only a few EDs across the country have been able to incorporate multidisciplinary care for their older patients, due to barriers such as personnel costs, work flow culture, and the 24 hour ED care model. We developed a two-step protocol to address these barriers: Step 1 is quick, sensitive screens for fall risk (4 Stage Balance Test), delirium (Brief Delirium Triage Screen), and frailty (Identifying Seniors at Risk Score). Patients with concerning results will be placed in an ED Observation Unit for (step 2) multidisciplinary geriatric assessment. In Aim 1 we will use the Consolidated Framework for Implementation Research and Lean Six Sigma methods to identify and address residual barriers to full implementation. Aim 2 will evaluate the effectiveness of this protocol in regards to patient-oriented outcomes (functional status and health-related quality of life at 90 days). By using implementation frameworks and processes, we will develop a protocol that is effective, sustainable, and ready for dissemination to EDs across the US.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
373

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 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

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 27, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 9, 2026

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

4.3 years

First QC Date

August 22, 2019

Results QC Date

March 30, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

GeriatricsEmergency MedicineImplementationConsolidated Framework for Implementation Research

Outcome Measures

Primary Outcomes (1)

  • Health Related Quality of Life (HRQoL) Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2 is a 10-item patient-reported questionnaire assessing overall health and well-being. It provides two summary scores: Global Physical Health and Global Mental Health. Each of the two scores are standardized to the general US population, with a mean of 50 and a standard deviation of 10. Higher scores indicate better physical or mental health. This measure is reported in raw scores of 4 to 20 (range), with T scores of 16.2 - 67.7.

    90 days

Secondary Outcomes (3)

  • Functional Status Using OARS: Older Americans Resources and Services Program Activities of Daily Living, Independent Activities of Daily Living Summary Scale

    90 days

  • Number of Participants Who Received Home Resources, Services and/or New Diagnoses of Geriatric Syndromes

    90 days

  • Geriatric Screening Rates

    90 days

Study Arms (2)

Pre Implementation

NO INTERVENTION

Adult patients \>65 years of age in the Emergency Department Observation Unit.

Post Implementation

ACTIVE COMPARATOR

Adult patients \>65 years of age in the Emergency Department Observation Unit.

Other: Geriatric Screening tools

Interventions

Lean Six Sigma implementation in the Emergency Department of nurse-driven geriatric screening tools and protocols for patients with fall risk, delirium, and high risk scores.

Post Implementation

Eligibility Criteria

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

You may qualify if:

  • Adult patients \>= 65 years old assigned to the Emergency Department Observation Unit for care

You may not qualify if:

  • need for inpatient care at the time of initial Emergency Department disposition
  • non-English speaking
  • acute psychiatric issues requiring stabilization by psychiatry team
  • prisoners
  • unable to consent and no legally authorized representative available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

  • Southerland LT, Stephens JA, Hunold KM, Carpenter CR, Mion LC, Krupinski L, Reider CR, Caterino JM. Effects of a Geriatric Emergency Department Multidisciplinary Intervention on Functional Status and Quality of Life: A Pre/Post Cohort Study. Acad Emerg Med. 2026 Jan;33(1):e70119. doi: 10.1111/acem.70119. Epub 2025 Aug 6.

  • Southerland LT, Stephens JA, Carpenter CR, Mion LC, Moffatt-Bruce SD, Zachman A, Hill M, Caterino JM. Study protocol for IMAGE: implementing multidisciplinary assessments for geriatric patients in an emergency department observation unit, a hybrid effectiveness/implementation study using the Consolidated Framework for Implementation Research. Implement Sci Commun. 2020 Feb 25;1:28. doi: 10.1186/s43058-020-00015-7. eCollection 2020.

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Lauren Southerland, Principal Investigator
Organization
The Ohio State University

Study Officials

  • Lauren Southerland, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Pre and post cohort study with an intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Emergency Medicine

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

September 27, 2019

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

January 9, 2026

Results First Posted

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations