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Implementation of Multidisciplinary Assessments for Geriatric Patients in an ED Observation Unit

Implementation of Multidisciplinary Assessments for Geriatric Patients in an Emergency Department Observation Unit

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04068311
Acronym
IMAGE
Enrollment
373
Registered
2019-08-28
Start date
2019-09-27
Completion date
2023-12-30
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Fall Patients, Functional Status, Quality of Life

Keywords

Geriatrics, Emergency Medicine, Implementation, Consolidated Framework for Implementation Research

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.

Detailed 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.

Interventions

OTHERGeriatric 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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Ohio State University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Pre and post cohort study with an intervention

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Health Related Quality of Life (HRQoL) Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.290 daysThe 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.

Secondary

MeasureTime frameDescription
Functional Status Using OARS: Older Americans Resources and Services Program Activities of Daily Living, Independent Activities of Daily Living Summary Scale90 daysWe 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.
Number of Participants Who Received Home Resources, Services and/or New Diagnoses of Geriatric Syndromes90 daysNumerical 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.
Geriatric Screening Rates90 daysPercentage 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

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Pre-Implementation Cohort
Cohort of participants enrolled prior to the implementation of geriatric screening throughout the Emergency Department
138
Post-Implementation Cohort
A cohort of participants enrolled after geriatric screening was implemented in the Emergency Department
230
Total368

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath33
Overall StudyLost to Follow-up2468
Overall StudyWithdrawal by Subject50

Baseline characteristics

CharacteristicTotalPost-Implementation CohortPre-Implementation Cohort
Age, Continuous73.3 years
STANDARD_DEVIATION 6.4
73.2 years
STANDARD_DEVIATION 6.4
73.4 years
STANDARD_DEVIATION 6.5
Charlson Comorbidity Index4.9 units on a scale
STANDARD_DEVIATION 2.3
4.79 units on a scale
STANDARD_DEVIATION 2.06
5.2 units on a scale
STANDARD_DEVIATION 2.65
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
365 Participants229 Participants136 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Global Mental Health Quality of Life score (PROMIS)50.4 T score
STANDARD_DEVIATION 8.1
50.8 T score
STANDARD_DEVIATION 8.1
49.6 T score
STANDARD_DEVIATION 8
Global Physical Health Quality of Life score (PROMIS)44.6 T score
STANDARD_DEVIATION 8.4
45.1 T score
STANDARD_DEVIATION 8.4
43.9 T score
STANDARD_DEVIATION 8.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
46 Participants28 Participants18 Participants
Race (NIH/OMB)
More than one race
2 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants3 Participants3 Participants
Race (NIH/OMB)
White
310 Participants196 Participants114 Participants
Sex: Female, Male
Female
187 Participants120 Participants67 Participants
Sex: Female, Male
Male
181 Participants110 Participants71 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 1433 / 230
other
Total, other adverse events
0 / 1430 / 230
serious
Total, serious adverse events
0 / 1430 / 230

Outcome results

Primary

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

Population: Change in HRQoL at 90 days was obtained by subtracting the t-score from day 0 to day 90 for each participant and comparing both cohorts. Therefore we changed the t scores to a delta in scores and report mean and standard deviation of the change.

ArmMeasureValue (MEAN)Dispersion
Pre-Implementation CohortHealth Related Quality of Life (HRQoL) Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2-0.73 T scoreStandard Deviation 6.98
Post-Implementation CohortHealth Related Quality of Life (HRQoL) Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2-0.33 T scoreStandard Deviation 5.46
p-value: 0.61Chi-squared
Secondary

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

Population: We defined a significant decline in Functional Status (OARS) as decrease of 3 or more points from day 0 to day 90. Comparisons between the pre and post cohorts were done using either Chi-square tests for proportions. A multivariable logistic regression model was planned to compare outcomes between the groups while controlling for any significant factors varying between the two cohorts, but was not able to be done due to the low number of primary outcome events.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-Implementation CohortFunctional Status Using OARS: Older Americans Resources and Services Program Activities of Daily Living, Independent Activities of Daily Living Summary Scale4 Participants
Post-Implementation CohortFunctional Status Using OARS: Older Americans Resources and Services Program Activities of Daily Living, Independent Activities of Daily Living Summary Scale5 Participants
p-value: 0.83Chi-squared
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-Implementation CohortGeriatric Screening Rates17 Participants
Post-Implementation CohortGeriatric Screening Rates210 Participants
p-value: <0.01Chi-squared
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-Implementation CohortNumber of Participants Who Received Home Resources, Services and/or New Diagnoses of Geriatric Syndromes33 Participants
Post-Implementation CohortNumber of Participants Who Received Home Resources, Services and/or New Diagnoses of Geriatric Syndromes67 Participants
p-value: 0.14Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026