Clinical trial NCT04068311: Implementation of Multidisciplinary Assessments for Geriatric Patients in an ED Observation Unit
Official title: Implementation of Multidisciplinary Assessments for Geriatric Patients in an Emergency Department Observation Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Patients
Delirium
Quality of Life
Functional Status
Keywords: Geriatrics
Emergency Medicine
Implementation
Consolidated Framework for Implementation Research
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-08-28
Enrollment: 373
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pre and post cohort study with an intervention
Primary purpose: PREVENTION

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 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health related Quality of Life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2
timeFrame: 90 days
Secondary outcomes:
measure: Functional Status using OARS: Older Americans Resources and Services Program ADL, IADL, and Summary Scale.
timeFrame: 90 days
measure: Home resources, services, and new diagnoses of geriatric syndromes
timeFrame: 90 days
measure: Geriatric Screening rates
timeFrame: 90 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Lauren Southerland, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Southerland LT, Stephens JA, Carpenter CR, Mion LC, Moffatt-Bruce SD, Zachman A, Hill M, Caterino JM. Study protocol for IMAGE: implementing multidisciplinary assessments for geriatric patients in an emergency department observation unit, a hybrid effectiveness/implementation study using the Consolidated Framework for Implementation Research. Implement Sci Commun. 2020 Feb 25;1:28. doi: 10.1186/s43058-020-00015-7. eCollection 2020.