A Communication Tool to Improve Communication in the ICU
NCT ID: NCT05780918
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
7600 participants
INTERVENTIONAL
2023-07-01
2026-12-31
Brief Summary
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Detailed Description
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The study team will follow an estimated 4,500 patients with the highest post-injury mortality: aged 50 years and older with an ICU length of stay of 3 or more days. They will administer surveys to family members (quality of communication) and clinicians (moral distress) and obtain patient-level outcomes (ICU length of stay (LOS)), clinical data, and demographics from the Trauma Quality Improvement Program (TQIP) national registry.
Objectives:
* Aim 1: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on improving the quality of communication in the trauma ICU.
* Aim 2: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on reducing clinician moral distress in the ICU.
* Aim 3: To test the effectiveness of the Best Case/Worst Case-ICU communication tool on reducing ICU length of stay.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
The intervention will be administered as a quality improvement activity because its primary purpose is to increase behaviors recommended by professional societies, e.g., timely communication with families and emotional support.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Best Case/Worst Case-ICU Communication Tool
Patients in the intervention group will receive care from a trauma team that routinely uses the Best Case/Worst Case-ICU communication tool.
Best Case/Worst Case-ICU Communication Tool
This intervention uses scenario planning and a daily report of the interplay between major events and prognosis to illustrate a range of long-term outcomes and treatment experiences. By using a graphic aid to illustrate "what we are hoping for," "what we are worried about," and the evolution of the patient's story over time, the tool aims to facilitate dialogue among older adult trauma patients, their families, and the trauma team. Because the tool delivers critical prognostic information over the longitudinal course of care, subsequent treatment decisions can be made within the context of the patient's overall health status. This information alerts patients and families to the life-limiting nature of serious injury and provides an entrée for them to consider how comfort-focused strategies might better align with patients' end-of-life goals.
All clinicians will be trained to create, use, and/or reference the graphic aids with patients depending on their roles in the trauma ICU.
Usual Care
Prior to implementation of the intervention, patients admitted to the trauma ICU will receive usual care. Usual care typically includes conversations focused on isolated problems, disarticulated from the patient's overall health trajectory. This is typified by the systems-base review, routinely summarizing each patient on rounds where the clinician lists each physiologic system, (e.g., neuro, cardiac, pulmonary…) with an assessment and plan to "fix" each abnormality with a new treatment. Deliberation about how these individual treatments align with patient preferences is typically prompted by major events like failure to liberate from a ventilator or imminent death. This pattern of usual care is well characterized and differs from daily scenario planning with the Best Case/Worst Case-ICU communication tool.
No interventions assigned to this group
Interventions
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Best Case/Worst Case-ICU Communication Tool
This intervention uses scenario planning and a daily report of the interplay between major events and prognosis to illustrate a range of long-term outcomes and treatment experiences. By using a graphic aid to illustrate "what we are hoping for," "what we are worried about," and the evolution of the patient's story over time, the tool aims to facilitate dialogue among older adult trauma patients, their families, and the trauma team. Because the tool delivers critical prognostic information over the longitudinal course of care, subsequent treatment decisions can be made within the context of the patient's overall health status. This information alerts patients and families to the life-limiting nature of serious injury and provides an entrée for them to consider how comfort-focused strategies might better align with patients' end-of-life goals.
All clinicians will be trained to create, use, and/or reference the graphic aids with patients depending on their roles in the trauma ICU.
Eligibility Criteria
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Inclusion Criteria
* admitted to the ICU for 3 or more days after serious injury
* aged 18 and older
* patient's family member or informally designated "like family" or primary surrogate decision maker
* speak English or Spanish
* provide care in the trauma ICU (including attending trauma surgeons, fellows, residents, advance practice providers, bedside nurses and medical assistants, respiratory techs and physical therapists, social workers, and chaplains)
Exclusion Criteria
Family Members
* does not have decision-making capacity
Clinicians
* do not provide care in the trauma ICU
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of Maryland, Baltimore
OTHER
University of California, Davis
OTHER
Harborview Injury Prevention and Research Center
OTHER
Lehigh Valley Health Network
OTHER
Grady Memorial Hospital
OTHER
Froedtert Hospital
OTHER
University of Alabama at Birmingham
OTHER
Rhode Island Hospital
OTHER
American College of Surgeons
OTHER
Coalition for National Trauma Research
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Margaret L Schwarze, MD, MPP
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California Davis Medical Center
Davis, California, United States
Grady Memorial Hospital - Morehouse School of Medicine
Atlanta, Georgia, United States
Shock Trauma - University of Maryland Medical Center
Baltimore, Maryland, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Rhode Island Hospital - Brown University
Providence, Rhode Island, United States
Harborview Medical Center - University of Washington
Seattle, Washington, United States
Froedtert Hospital - Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Stalter L, Hanlon BM, Bushaw KJ, Kwekkeboom KL, Zelenski A, Fritz M, Buffington A, Stein DM, Cocanour CS, Robles AJ, Jansen J, Brasel K, O'Connell KM, Cipolle MD, Ayoung-Chee P, Morris R, Gelbard RB, Kozar RA, Lueckel S, Schwarze M. Best Case/Worst Case-ICU: protocol for a multisite, stepped-wedge, randomised clinical trial of scenario planning to improve communication in the ICU in US trauma centres for older adults with serious injury. BMJ Open. 2024 Aug 28;14(8):e083603. doi: 10.1136/bmjopen-2023-083603.
Other Identifiers
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Protocol Version 5/5/2025
Identifier Type: OTHER
Identifier Source: secondary_id
A539750
Identifier Type: OTHER
Identifier Source: secondary_id
2022-0334
Identifier Type: -
Identifier Source: org_study_id
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