Implementation of Multidisciplinary Assessments for Geriatric Patients in an Emergency Department Observation Unit
Phase: NA
Conditions: Fall Patients, Delirium, Quality of Life, Functional Status
Sponsor: Ohio State University

 
 
v1.0 3-11-2019 
IMAGE Protocol 
PI: Lauren T. Southerland, MD 
 
I. Study Overview: 
 
A. Summary: This is an Implementation/Effectiveness hybrid study, where Aim 1 evaluates the 
implementation process and Aim 2 evaluates the effectiveness of a clinical protocol. The protocol in this 
study is a two step protocol to identify and manage geriatric syndromes in the Emergency Department 
(ED).  Step 1 is nurse screening for geriatric syndromes using three previously validated tools: the Brief 
Delirium Triage Screen (Delirium screen), the 4 Stage Balance Test (4SBT), and the Identifying Seniors at 
Risk score (ISAR). Step 2 is management of patients who screen positive either by admission to the 
hospital or further investigation and treatment in the ED Observation Unit (Obs Unit).   
For Aim 1, Implementation, the process will 
be evaluated qualitatively and quantitatively.  
Data will be collected on the actions and 
perceptions of hospital staff. The 
implementation procedures done will follow 
Lean Six Sigma processes, which is the 
standard implementation process of our 
hospital system.  We will also monitor the 
implementation process using aggregate 
quality data from the ED, currently already 
collected monthly as part of QI measures. No 
identifying information on staff will be 
collected as part of the study.  
For Aim 2, Effectiveness, data will be collected 
prospectively from patient participants in before and after cohorts.   
 
B. Intervention: The two-step intervention will begin with the patient’s primary ED nurse 
screening for geriatric syndromes. The ED physician will then determine if multidisciplinary intervention 
is needed and the appropriate level of care (eg, dementia may cause a positive delirium screen, but may 
not require evaluation if cognitive status is at baseline). Patients requiring multidisciplinary assessment 
will be either admitted or assigned to the Obs Unit for geriatric assessments based on standard care of 
their medical problems. These assessments are in addition to usual care for the patient’s underlying 
medical complaint. Geriatric consultation involves evaluation by the hospital’s geriatric consultation 
team: a board certified geriatrician, a geriatric nurse practitioner, and fellows. PT assessments are done 
by hospital PTs. Medication reviews are completed by ED pharmacists and include confirmation of 
medication list and dosages and assessment of possible medication interactions or potentially 
Table 1: Study specific abbreviations and definitions. 
4SBT 
4 Stage Balance Test. A fall risk assessment 
DMAIC 
Define, Measure, Analyze, Improve, Control. 
Part of the Lean Six Sigma methodology. 
CFIR 
Consolidated Framework for Implementation 
Research (CFIR) 
ED/EM 
Emergency Department/ Medicine 
EMR 
Electronic Medical Record 
HRQoL 
Health Related Quality of Life 
ISAR 
Identifying Seniors at Risk Score 
OARS 
Older Americans’ Resources and Services 
Activities of Daily Living questionnaire.  
Obs Unit 
Emergency Department Observation Unit 
PROMIS 
Patient Report Outcomes Measurement 
Information System- a HRQoL scale.  
PT 
Physical therapy or therapist 
QI 
Quality improvement 
Sustainability 
Survey 
Measurement Instrument for Sustainability of 
Changed Work Practices 

 
 
v1.0 3-11-2019 
inappropriate medications using standard criteria.1 The case management team includes nurse case 
managers and licensed social workers.  
 
This intervention is already in place, however currently only 5% of older adults in the ED are 
receiving the screening and only 11% are placed in the Obs Unit for further assessment.  Based on data 
from other institutions, this is likely an underutilized service and we are missing many older adults with 
acute needs. The goal of implementation is to increase nurse screening to >80% and protocol 
compliance to >80%.   
 
C.  Rationale for study: The data collected for Aim 1 is partly from our baseline ED metrics but 
also data collected as a result of our accreditation as a Level 1 Geriatric ED. As part of that process, we 
have to track dispositions, 72 hour return rates, morbidity and mortality reports, readmissions, and 
geriatric screening rates.  This is current monthly report.  Additionally, we have to do chart reviews to 
assess compliance to our geriatric quality protocols.  The intervention in question is included as part of 
our geriatric protocols. This intervention is not "new", it has been ongoing since 2015.  However, a 
formal implementation process is needed as education and accreditation have not been able to increase 
our screening and compliance rates above 5%.  For this reason, Dr. Southerland took 80 hr of Lean Six 
Sigma Green Belt training in 2017-2018.   
 
The research in this study that would not be done normally as part of normal QI at OSU is Aim 2, 
evaluating the effectiveness of the protocol.  Aim 2 will involve recruiting and consenting patients for 
prospective analysis to determine the impact of the protocol on patient centered outcomes.  
 
 
 
 
 
 
II. Aim 1 Protocols 
 
A. Specific Aim: 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. We will use mixed-methods approaches 
and the CFIR framework to identify resource, organizational, patient, staff, and administrative factors 
that affect protocol adherence.2-4  We will use Lean Six Sigma processes to overcome barriers. We will 
track effects of the protocol in reference to ED quality metrics, staff work flow, and work culture.  
Table 2: Study Timeline 
Months 
Study Phase 
Aim 1: Implementation 
Aim 2: Effectiveness 
0-3 
Startup 
- Lean team training 
Enrollment preparation 
3-15 
Baseline  
- Work flow analyses 
 
- Enroll for baseline 
cohort (n=150) 
16-32 
Preparation/ 
Implement-
ation 
- Process data collection and 
Implementation surveys. Lean Six 
Sigma rapid process improvement 
- Follow up and 
baseline data analysis 
33-56 
Maintenance/ 
Sustainability  
 
- Continue process data collection 
-Enroll post implemen-
tation cohort (n=230) 
- Data collection and 
analysis 
- Withdrawal of implementation 
strategies; Sustainability survey at 
months 44 and 56. 

 
 
v1.0 3-11-2019 
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, we will characterize the 
necessary elements for sustainability by systematically withdrawing implementation support 
strategies. We hypothesize that 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.5  
 
B. Subjects: Aim 1 will include analysis of aggregate ED EMR data on ED patients ≥65 overall (1a) 
and in the ED obs unit (1b). ED staff and Lean team members are also study subjects for Aim 1. All ED 
and obs unit physicians, midlevel providers, nurses, pharmacists, and involved consultants/stakeholders 
are eligible, yielding an estimated 260 people. While staff participation in the implementation process 
and surveys is voluntary, participation in the education and protocol is mandatory. 
 
 
C. Data Collection:  1) Monthly aggregate EMR data on all ED patients is collected as part of 
general quality measures. This includes: Obs Unit census, patient demographics, geriatric screening 
results, consultation rates for the multidisciplinary geriatric services, and dispositions from the ED. 2) 
Staff Surveys will be sent electronically using REDCap (Vanderbilt University, TN).6,7 There will be at least 
2 types of staff surveys: the Implementation survey in Preparation and Implementation phases and the 
Sustainability scale survey.  3) Observational data: Trained observers will perform work flow analyses 
per usual practice.8 The first workflow analysis has already been done and was determined to be IRB 
exempt as it is a standard QI analysis done for QI purposes.  
 
The only time that identifiable staff information will be used for research purposes will be using 
staff emails to send out surveys.  In keeping with prior practices, all surveys sent to nursing staff will be 
approved by nursing leadership in addition to the IRB. Individual respondents' emails will be used to 
allow for paired comparison of survey responses for the sustainability survey at 12 and 24months after 
implementation. Otherwise all survey information will be aggregated without identifiers.  Survey 
completion is voluntary and will not affect their work opportunities or be reported to their supervisors.  
Similarly, staff who are observed during workflow analyses will not have their names reported, but 
instead will be listed as RN-A1, RN-A2, tech-A1, etc.  
 
 
D. Aim 1 Timeline/ Methods:  
F.7.i: Preparation (3 months): Mirroring the normal process at our site, we will convene a Lean 
implementation team including: study PI, Obs Nurse Champion, ED Nurse Educator, and representatives 
from pharmacy, safety, geriatrics, case management, and informatics. All personnel have prior Lean 
training/experience or will receive training. Standard Lean processes will be followed, such as use of a 
Gantt chart for task management. The Lean team will review current data and identify barriers to 
implementation. A staff survey (Implementation Survey) will identify beliefs and domains for 
improvement. Based on prior studies using the CFIR,2,4 domains of interest will be: 1) beliefs about 
capabilities, 2) professional role/identity; 3) barriers/facilitators to screening; 4) attitudes; and 5) social 
influences. Education will consist of 2 hours of nurse training, led by our ED nurse educator (Peg Gulker) 

 
 
v1.0 3-11-2019 
who has Geriatric Emergency Nurse Education (GENE) certification.9 Select nurse champions who self-
identify as interested in assisting with the process will also complete the GENE course and/or online 
modules (Geri-EM.com). 
F.7.ii: Implementation (12 months): We will use the Lean Six Sigma DMAIC process (Define, Measure, 
Analyze, Improve, and Control) and rapid cycles of process improvement. Key enablers and barriers will 
be identified from the data obtained during Preparation. Team workshops will be used to generate 
solutions. These generated solutions are tested and results measured using aggregate EMR reports. 
These reports are summarized in the form of A3 sheets, tracked, and discussed during weekly team 
meetings, which can generate additional issues and new improvement cycles. At 6 months into this 
process, the Implementation Survey will be re-administered to assess changes and identify further 
areas of focus.  The implementation team will also assess the added burden to staff and look for any 
adverse outcomes on ED metrics, such as ED length of stay and admission rates.  
 F.7.iii: Maintenance and Sustainability (32 months): Maintenance: After the goals of >80% screening 
rate with > 80% protocol fidelity is achieved for 6 months, implementation will be considered successful. 
The Control/Maintenance phase of the DMAIC process begin. All new nurses and staff will receive the 
geriatric training. Existing staff will have annual training to review and reinforce their geriatric 
knowledge. The Lean team will continue to meet monthly, but rapid cycle process improvement will halt 
unless concerning trends are noted. Sustainability: At 12 and 24 months after Maintenance phase 
initiation, we will assess the degree of routinization and institutionalization among all 180 ED nurses via 
a Sustainability survey (estimated response rate 70%).5 Implementation support will be withdrawn in a 
stepwise fashion in 3 month blocks. For example, fidelity audits may be decreased from weekly to 
monthly to semi-annually. If concerning trends are noted in the monthly aggregate EMR data, these 
processes will be reinstated and the Lean team will be reconvened. Per STARI guidelines,10 we will 
monitor for any contextual changes that occur during this time that may affect results and any 
adaptations to the protocol. Reporting continued maintenance of a program as the only measure of 
sustainability is insufficient, as program adaptation may also signal further benefits or sustained 
improvement.11 
 
III. Aim 2 Protocol 
A. Specific Aim:  To reduce the decline in functional status and health related quality of life 
(HRQoL) commonly seen after older adults experience an ED visit.12-14  We will recruit cohorts pre and 
post implementation.  
 
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 intervention patients.  
 
 

 
 
v1.0 3-11-2019 
 
B. Participant Selection: Adults ≥65 years assigned to the Obs Unit at the discretion of the 
treating physician will be enrolled (n=380). Patients may be in Obs as part of an Obs protocol (e.g., chest 
pain) or in response to a positive geriatric screening test. Patients with delirium or dementia will be 
enrolled with an LAR and patient assent. Exclusion criteria are need for inpatient care, non-English 
speaking, acute psychiatric issues, prisoners, unable to follow-up, or unable to consent and no LAR.   
 
Study personnel will monitor the Obs Unit electronic tracking board (7am-11pm M-F and select 
weekends) to identify and recruit 380 patients (150 pre and 230 post cohorts).  
 
 
C. Data Collection: A survey and chart review will be completed during the Obs stay (Table 3). 
Follow up phone interviews will occur at days 30±3 and 90±5. In simulations with research staff, survey 
completion required 8-10 minutes of patient time.  Patient data will be collected in REDCap, which has 
built in scoring tools for PROMIS measures. Chart abstraction will be done by research coordinators and 
will use standard methods (including training of abstractors, standardized forms, code book, etc).15  
 
  
 
Data collection definitions:  
OARS:16 (Primary Outcome) An assessment of activities of daily living (functional status) 
commonly used in ED studies. We will obtain 4 timepoints: Premorbid (patient report of 
function 1 week prior to ED visit), at the ED visit (day 0), and at days 30 and 90. A change of ≥3 
points or death between is a significant decline.12,17 
HRQoL: The Patient Reported Outcomes Measurement information System (PROMIS) is 
endorsed by the NIH and PCORI. We will use the Global Health v1.2 (10 questions). A 3 point 
change is clinically meaningful.18  
New services: Number of new or increased outpatient services (e.g., home health therapies, 
referral for community interventions, equipment). 
New geriatric syndrome19 diagnoses of delirium, impaired cognition, fall risk, or elder 
mistreatment. 
Geriatric clinic referral: Referrals to the Falls Prevention, Polypharmacy, or Geriatrics Clinic.  
Pharmacist recommendations: Number of medication related problems/interactions.1,20  
Positive geriatric interventions: ≥1 of: new services, diagnoses, referrals, or pharmacist recs. 
ED revisits and hospitalizations: Any ED revisits or unscheduled hospitalizations within 90 
days.21  
Patient satisfaction: interview data with themes of positive patient outcomes or satisfaction. 
Table3: Patient level data collected for Aim 2. 
Chart review 
Patient interview 
Day 0 - Demographics and zip code 
- Charlson Comorbidity Index 
- Observation protocol  
- Geriatric screening scores 
- Geriatric assessments 
- New geriatric syndromes 
- Geriatric clinic referrals 
- Medication recommendations 
- New services 
- Disposition and length of stay 
- OARS and HRQoL  
- Current level of care 
- Falls in the past month 
- Current home health and 
community resources 
 
- (subset) semi-structured 
interviews.  
Days 
30, 90 
- Clinic referrals and follow-up 
- ED revisits and 
- OARS and  HRQoL 
- Current level of care  

 
 
v1.0 3-11-2019 
 
 
 
 
 
Qualitative data: At least 20 patients in the post cohort will be selected for semi-structured 
interviews.  Interviews will be led by a trained researcher coordinator. Purposeful sampling will be used 
to provide a mix of genders, ages, and Obs Unit dispositions. To assess patient satisfaction, (Aim 2b), a 
trained researcher will conduct in-person, semi-structured interviews with intervention patients. In 
addition to Likert-type questions, we will solicit brief descriptions of clinical exemplars of how this 
intervention produced a positive patient outcome. See interview guide. Maximum variation/ 
heterogeneous purposive sampling will provide a mix of genders, ages, and observation dispositions. 
This interview will add an additional 20 minutes to the patient's participation time, and so we expect 
that some participants may decline this portion. With 230 patients in the post implementation cohort, 
we should have sufficient volume to get at least 20 patients to participate in the qualitative data 
collection.   
 
D. Follow up:  The participants will be followed for 90±5 days.  The follow up interviews will be 
done over the phone. If the participant prefers, these can be scheduled by email to allow them to 
choose an appropriate and easy time.  Email reminders can also be sent if the participant prefers that 
communication strategy.  LAR or caregivers are invited to be present at during the follow up calls. If the 
participant and the LAR/caregiver give antithetical answers to a question, both answers will be recorded  
to track how often this occurs, but only the LAR's answers will be used for the final analysis. All 
participants will be mailed a Thank you Card from the PI for participating at the end of study enrollment.  
 
IV. Data Analysis 
A.  Aim 1a outcome definition: Screening rate is defined as the percentage of ED patients ≥ 65 
years old who have documentation of all 3 screens (4SBT, ISAR, Delirium). Protocol Fidelity is the 
percentage of screen positive patients in the Obs Unit who receive all appropriate consultations as 
noted on EMR data. Secondary outcomes include the number of cycles required to reach 80% screening, 
any protocol adaptions, and fidelity to Lean methods. Fidelity to Lean will be measured by (1) Lean 
documents, (2) completion of ≥2 rapid improvement cycles, and (3) representation from both leadership 
and frontline employees at meetings.  
Aim 1b outcome definition: We will characterize the necessary elements to maintain screening 
rates >80%. We will use X-bar and R-charts to evaluate for special process variation as we withdraw 
implementation support. Any support withdrawal that leads to significant decrease in screening rates 
will be considered necessary and the Lean team will address the problem. For sustainability, we will 
summarize and report the mean total and subsection scores at each timepoint. The main outcome is 
the change in scores over time. Secondarily, any mean subscores < 3.0 on the Sustainability Survey will 
be considered areas of weakness in the protocol and reported as possible threats to sustainability.22 
 
 
hospitalizations 
- Falls since last contact 
- Home health and 
community resources used 

 
 
v1.0 3-11-2019 
Analysis: Monthly summary statistics on geriatric patient visits, screening and consultation will 
be recorded. For Hypotheses 1a.i and1a.ii (Implementation) we will calculate the proportions for 
screening rate and protocol fidelity with 95% CIs monthly using aggregate data. Success is predefined as 
a point estimate >80% for each outcome for 6 months. The Staff Implementation Surveys (both pre- and 
post-implementation) will be thematically analyzed used Atlas.ti (Cleverbridge, Inc, Chicago, IL) a 
qualitative data analysis program, and categorized within the CFIR framework. This data will be used to 
further the implementation process. Additional assessments of implementation will include: the number 
of improvement cycles, generated solutions and protocol adaptations, and Lean fidelity. Lean fidelity will 
be assessed as a yes/no variable at conclusion of implementation. For Hypothesis 1b, (Sustainability) we 
will compare the total mean scores (primary outcome) between the 2 years taking into account linked 
responses by the same nurses in both years using a mixed model.  We will compare individuals' scores 
over time using a paired t-test or Sign Rank test.   
 
B. Aim 2: Participant representativeness will be assessed by comparison to demographics of all 
ED patients. The primary outcome for Aim 2a is the proportion of patients in the pre and post cohort 
with a significant (≥3 point) decline in Functional Status (OARS) from day 0 to day 90. We will compare 
proportions with decline in the pre- and post-group using a Chi-square test (primary analysis). Also, 
logistic regression modeling will be used to compare the functional decline between the pre and post 
intervention groups univariately and while controlling for initial ED HRQoL, demographic factors (age, 
race, average socioeconomic status from zip code census tract), Charlson Comorbidity Index score,23 
number of services used and any other significant factors varying between the two cohorts. The total 
number of covariates will not exceed 12, given we estimate 122 subjects with functional decline. A 
similar secondary analysis will be done using the 30 day timepoint data. 
Secondary outcomes for 2a: Dichotomous secondary outcomes will be analyzed using 
proportions and chi-square tests between pre- and post-intervention groups and with exploratory 
logistic regression models. Count data will be explored using either Poisson or negative binomial 
regression. Exploratory analyses will use similar methods to compare the pre-intervention group to the 
post- subgroup who received all 3 screens. 
F.12.ii For Aim 2b, interviews will be transcribed verbatim and entered into Atlas.ti. We will 
conduct manifest content analysis of the descriptions using phrases and sentences as our unit of 
analysis.24,25 We will categorize the exemplars and analyze for appropriateness and perceived outcomes 
based on the level of detail provided. Analysis will include open and axial coding procedures using 
techniques of constant comparison and questioning within and across cases.26,27 The coding schema will 
be created with consensus on coding definitions and grouping codes into code families/categories. Dual 
coding with negotiated consensus will be performed on 20% of the data to add rigor to the analysis. 
Themes will be reported per current guidelines.28,29 
 
 

 
 
v1.0 3-11-2019 
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