Trial Outcomes & Findings for Implementation of Multidisciplinary Assessments for Geriatric Patients in an ED Observation Unit (NCT NCT04068311)
NCT ID: NCT04068311
Last Updated: 2026-01-09
Results Overview
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.
COMPLETED
NA
373 participants
90 days
2026-01-09
Participant Flow
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.
Participant milestones
| Measure |
Pre-Implementation Cohort
Cohort of participants enrolled prior to the implementation of geriatric screening throughout the Emergency Department
|
Post-Implementation Cohort
A cohort of participants enrolled after geriatric screening was implemented in the Emergency Department
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
230
|
|
Overall Study
Recruited
|
143
|
230
|
|
Overall Study
Analysis set
|
138
|
230
|
|
Overall Study
COMPLETED
|
111
|
159
|
|
Overall Study
NOT COMPLETED
|
32
|
71
|
Reasons for withdrawal
| Measure |
Pre-Implementation Cohort
Cohort of participants enrolled prior to the implementation of geriatric screening throughout the Emergency Department
|
Post-Implementation Cohort
A cohort of participants enrolled after geriatric screening was implemented in the Emergency Department
|
|---|---|---|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
24
|
68
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
Baseline Characteristics
Implementation of Multidisciplinary Assessments for Geriatric Patients in an ED Observation Unit
Baseline characteristics by cohort
| Measure |
Pre-Implementation Cohort
n=138 Participants
Cohort of participants enrolled prior to the implementation of geriatric screening throughout the Emergency Department
|
Post-Implementation Cohort
n=230 Participants
A cohort of participants enrolled after geriatric screening was implemented in the Emergency Department
|
Total
n=368 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.4 years
STANDARD_DEVIATION 6.5 • n=8 Participants
|
73.2 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
73.3 years
STANDARD_DEVIATION 6.4 • n=15 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=8 Participants
|
120 Participants
n=7 Participants
|
187 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=8 Participants
|
110 Participants
n=7 Participants
|
181 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
136 Participants
n=8 Participants
|
229 Participants
n=7 Participants
|
365 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=8 Participants
|
28 Participants
n=7 Participants
|
46 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=8 Participants
|
196 Participants
n=7 Participants
|
310 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=15 Participants
|
|
Charlson Comorbidity Index
|
5.2 units on a scale
STANDARD_DEVIATION 2.65 • n=8 Participants
|
4.79 units on a scale
STANDARD_DEVIATION 2.06 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.3 • n=15 Participants
|
|
Global Physical Health Quality of Life score (PROMIS)
|
43.9 T score
STANDARD_DEVIATION 8.4 • n=8 Participants
|
45.1 T score
STANDARD_DEVIATION 8.4 • n=7 Participants
|
44.6 T score
STANDARD_DEVIATION 8.4 • n=15 Participants
|
|
Global Mental Health Quality of Life score (PROMIS)
|
49.6 T score
STANDARD_DEVIATION 8.0 • n=8 Participants
|
50.8 T score
STANDARD_DEVIATION 8.1 • n=7 Participants
|
50.4 T score
STANDARD_DEVIATION 8.1 • n=15 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: 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.
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.
Outcome measures
| Measure |
Pre-Implementation Cohort
n=111 Participants
Cohort of participants enrolled prior to the implementation of geriatric screening throughout the Emergency Department
|
Post-Implementation Cohort
n=161 Participants
A cohort of participants enrolled after geriatric screening was implemented in the Emergency Department
|
|---|---|---|
|
Health Related Quality of Life (HRQoL) Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2
|
-0.73 T score
Standard Deviation 6.98
|
-0.33 T score
Standard Deviation 5.46
|
SECONDARY outcome
Timeframe: 90 daysPopulation: 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.
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.
Outcome measures
| Measure |
Pre-Implementation Cohort
n=111 Participants
Cohort of participants enrolled prior to the implementation of geriatric screening throughout the Emergency Department
|
Post-Implementation Cohort
n=159 Participants
A cohort of participants enrolled after geriatric screening was implemented in the Emergency Department
|
|---|---|---|
|
Functional Status Using OARS: Older Americans Resources and Services Program Activities of Daily Living, Independent Activities of Daily Living Summary Scale
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 90 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.
Outcome measures
| Measure |
Pre-Implementation Cohort
n=138 Participants
Cohort of participants enrolled prior to the implementation of geriatric screening throughout the Emergency Department
|
Post-Implementation Cohort
n=230 Participants
A cohort of participants enrolled after geriatric screening was implemented in the Emergency Department
|
|---|---|---|
|
Number of Participants Who Received Home Resources, Services and/or New Diagnoses of Geriatric Syndromes
|
33 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: 90 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
Outcome measures
| Measure |
Pre-Implementation Cohort
n=138 Participants
Cohort of participants enrolled prior to the implementation of geriatric screening throughout the Emergency Department
|
Post-Implementation Cohort
n=230 Participants
A cohort of participants enrolled after geriatric screening was implemented in the Emergency Department
|
|---|---|---|
|
Geriatric Screening Rates
|
17 Participants
|
210 Participants
|
Adverse Events
Pre-Implementation Cohort
Post-Implementation Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lauren Southerland, Principal Investigator
The Ohio State University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place