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Clinical Trials/NCT04068311
NCT04068311CompletedNot Applicable

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

Ohio State University1 site in 1 country373 target enrollmentStarted: September 27, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
373
Locations
1
Primary Endpoint
Health Related Quality of Life (HRQoL) Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

Pre Implementation

No Intervention

Adult patients >65 years of age in the Emergency Department Observation Unit.

Post Implementation

Active Comparator

Adult patients >65 years of age in the Emergency Department Observation Unit.

Intervention: Geriatric Screening tools (Other)

Outcomes

Primary Outcomes

Health Related Quality of Life (HRQoL) Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2

Time Frame: 90 days

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.

Secondary Outcomes

  • Functional Status Using OARS: Older Americans Resources and Services Program Activities of Daily Living, Independent Activities of Daily Living Summary Scale(90 days)
  • Number of Participants Who Received Home Resources, Services and/or New Diagnoses of Geriatric Syndromes(90 days)
  • Geriatric Screening Rates(90 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lauren Southerland

Associate Professor, Department of Emergency Medicine

Ohio State University

Study Sites (1)

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