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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.


Recruitment information / eligibility

Status Completed
Enrollment 373
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Adult patients >= 65 years old assigned to the ED Observation Unit for care Exclusion Criteria: - Need for inpatient care at the time of initial ED disposition - non-English speaking - acute psychiatric issues requiring stabilization by psychiatry team - prisoners - unable to consent and no legally authorized representative available.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Geriatric Screening tools
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.

Locations

Country Name City State
United States The Ohio State University Wexner Medical Center Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health related Quality of Life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2 Reported in raw scores of 4 to 20, with T scores of 16.2 - 67.7. As we are comparing individuals over time, a change in raw score of 3 or more is considered clinically significant. 90 days
Secondary Functional Status using OARS: Older Americans Resources and Services Program ADL, IADL, and Summary Scale. Score ranges from 0-28, with higher scores representing worsening functional status. A change of 3 points is considered clinically significant. 90 days
Secondary Home resources, services, and new diagnoses of geriatric syndromes Numerical tally of the outcomes of multidisciplinary geriatric assessment- arrangement for new home resources such as medical equipment and mobility equipment, new services such as home health, and new diagnoses of geriatrics syndromes. 90 days
Secondary Geriatric Screening rates Percentage of older adults in the ED who are screened for geriatric syndromes with the Identifying Seniors at Risk tool, the brief delirium triage screen, and the 4 Stage Balance Test 90 days
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