Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04068311 |
| Other study ID # |
2019H0109 |
| Secondary ID |
K23AG061284-01A1 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2019 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Ohio State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 EM 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.
Description:
Older adult patients in the Emergency Department frequently experience poor outcomes due to
lack of recognition of underlying syndromes, such as delirium, polypharmacy, falls, and
social needs. This study uses rigorous implementation science processes to implement and
investigate an ED protocol to screen older adults for these syndromes and address them with
multidisciplinary geriatric assessments in an ED Observation Unit. Using an Observation Unit
to evaluate older adult patients at risk is a novel strategy developed to address the current
barriers of sustainability, cost, and timeliness that arose in prior studies of geriatric
assessments in an ED setting.
Specific Aim 1: Implementation: Develop, implement, and sustain a two-step intervention
providing ED geriatric assessments by combining 1) ED nurse-based screening for geriatric
syndromes of all older ED patients with 2) multidisciplinary geriatric assessment in an ED
Obs Unit. Mixed-methods approaches and the Consolidated Framework for Implementation (CFIR)
will be used to identify resource, organizational, patient, staff, and administrative factors
that affect protocol adherence. Lean Six Sigma processes will be used to overcome barriers.
The effects of the protocol in reference to ED quality metrics, staff work flow, and work
culture will be tracked.
Hypothesis 1a: Implementation: Lean Six Sigma processes will i) increase ED nurse-based
screening rates to >80% older adults in the ED and ii) increase protocol fidelity in the Obs
Unit to >80%.
Hypothesis 1b: Sustainability: After 6 months of >80% screening, the investigators will
characterize the necessary elements for sustainability by systematically withdrawing
implementation support strategies. Hypothesis: Attention to CFIR elements during
implementation will result in routinization and institutionalization that does not
significantly decrease with withdrawal or time, as assessed by sustainability surveys.37
Specific Aim 2: Effectiveness: The investigators will describe the effect of this protocol on
reducing the decline in functional status and reducing other patient and systems outcomes
(e.g. health related quality of life (HRQoL)) commonly seen after an ED visit.38-40 To obtain
patient-centered outcomes, two patient cohorts (pre and post implementation) will be
recruited.
Hypothesis 2a: The intervention will reduce the decline in functional status seen after ED
visits. Secondary outcomes include health-related quality of life, ED revisits, and results
of the multidisciplinary assessments.
Hypothesis 2b: Patients will be satisfied with the protocol as assessed by thematic analysis
of qualitative subject interviews of post intervention patients.
