An interventional study of Geriatric Screening tools in Fall Patients, Delirium and Quality of Life, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Ohio State University · Not applicable, Interventional, and Prevention
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.
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 373 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
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Exclusion Criteria:
Adult patients \>65 years of age in the Emergency Department Observation Unit.
Adult patients \>65 years of age in the Emergency Department Observation Unit.
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.
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.
Time frame: 90 days
Functional Status Using OARS: Older Americans Resources and Services Program Activities of Daily Living, Independent Activities of Daily Living Summary Scale
We report the number of participants with a decrease of 3 points or more, our definition of functional decline. The OARS: Older Americans Resources and Services Program Activities of Daily Living Score ranges from 0-28, with higher scores representing worsening functional status. A change of 3 points is considered clinically significant functional decline.
Time frame: 90 days
Number of Participants Who Received Home Resources, Services and/or 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.
Time frame: 90 days
Geriatric Screening Rates
Percentage of older adults in the Emergency Department who are screened for geriatric syndromes with the Identifying Seniors at Risk tool, the brief delirium triage screen, and the 4 Stage Balance Test
Time frame: 90 days
Recruitment for the pre-implementation cohort occurred Sep 2019 - Nov 2020. Recruitment was terminated early due to external pressures \[we were at risk of losing accreditation as a Level 1 Geriatric emergency department if we did not show progress\]. Implementation roll out was paused until March 2021 due to the COVID-19 pandemic. The implementation period was March 2021-August 2022. The post-implementation cohort enrolled from Sep 2022-Aug 2023.
| Milestone | Pre-Implementation Cohort | Post-Implementation Cohort |
|---|---|---|
| Started | 143 | 230 |
| Recruited | 143 | 230 |
| Analysis set | 138 | 230 |
| Completed | 111 | 159 |
| Not completed | 32 | 71 |
| Withdrew: Death | 3 | 3 |
| Withdrew: Lost to follow-up | 24 | 68 |
| Withdrew: Withdrawal by subject | 5 | 0 |
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.
| T score | Pre-Implementation Cohort | Post-Implementation Cohort |
|---|---|---|
| Health Related Quality of Life (HRQoL) Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2 | -0.73 ± 6.98 | -0.33 ± 5.46 |
We report the number of participants with a decrease of 3 points or more, our definition of functional decline. The OARS: Older Americans Resources and Services Program Activities of Daily Living Score ranges from 0-28, with higher scores representing worsening functional status. A change of 3 points is considered clinically significant functional decline.
| Participants | Pre-Implementation Cohort | Post-Implementation Cohort |
|---|---|---|
| Functional Status Using OARS: Older Americans Resources and Services Program Activities of Daily Living, Independent Activities of Daily Living Summary Scale | 4 | 5 |
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.
| Participants | Pre-Implementation Cohort | Post-Implementation Cohort |
|---|---|---|
| Number of Participants Who Received Home Resources, Services and/or New Diagnoses of Geriatric Syndromes | 33 | 67 |
Percentage of older adults in the Emergency Department who are screened for geriatric syndromes with the Identifying Seniors at Risk tool, the brief delirium triage screen, and the 4 Stage Balance Test
| Participants | Pre-Implementation Cohort | Post-Implementation Cohort |
|---|---|---|
| Geriatric Screening Rates | 17 | 210 |
Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-Implementation Cohort | 3/143 (2.1%) | 0/143 (0%) | 0/143 (0%) |
| Post-Implementation Cohort | 3/230 (1.3%) | 0/230 (0%) | 0/230 (0%) |
| Age, Continuous(years) | Pre-Implementation Cohort | Post-Implementation Cohort | Total |
|---|---|---|---|
| Mean | 73.4 ± 6.5 | 73.2 ± 6.4 | 73.3 ± 6.4 |
| Sex: Female, Male(Participants) | Pre-Implementation Cohort | Post-Implementation Cohort | Total |
|---|---|---|---|
| Female | 67 | 120 | 187 |
| Male | 71 | 110 | 181 |
| Ethnicity (NIH/OMB)(Participants) | Pre-Implementation Cohort | Post-Implementation Cohort | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 136 | 229 | 365 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pre-Implementation Cohort | Post-Implementation Cohort | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 18 | 28 | 46 |
| White | 114 | 196 | 310 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 3 | 3 | 6 |
| Charlson Comorbidity Index(units on a scale) | Pre-Implementation Cohort | Post-Implementation Cohort | Total |
|---|---|---|---|
| Mean | 5.2 ± 2.65 | 4.79 ± 2.06 | 4.9 ± 2.3 |
| Global Physical Health Quality of Life score (PROMIS)(T score) | Pre-Implementation Cohort | Post-Implementation Cohort | Total |
|---|---|---|---|
| Mean | 43.9 ± 8.4 | 45.1 ± 8.4 | 44.6 ± 8.4 |
| Global Mental Health Quality of Life score (PROMIS)(T score) | Pre-Implementation Cohort | Post-Implementation Cohort | Total |
|---|---|---|---|
| Mean | 49.6 ± 8.0 | 50.8 ± 8.1 | 50.4 ± 8.1 |
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