A Communication Tool to Improve Communication in the ICU

NCT05780918 | Active Not Recruiting DMC

• 4 other identifiers: 2022-0334R01AG078242-01Protocol Version 5/5/2025A539750
• Study Type: interventional
• Target: 7,600
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to test the effectiveness of the Best Case/Worst Case-ICU communication tool on quality of communication, clinician moral distress, and ICU length of stay for older adults with serious traumatic injury. Investigators will follow an estimated 4500 patients aged 50 years and older who are in the ICU for 3 or more days and survey 1500 family members and up to 1600 clinicians from 8 sites nationwide.

Conditions

Serious Injury; Communication

Keywords

intensive care unit; trauma; patient decision making; surgical decision making; shared decision making; decision support techniques

Outcome Measures

Primary Outcomes (1)

• Family-reported Quality of Communication (QOC) within 5-7 days of ICU admission

  Family-reported quality of communication will be measured using the 20-item Quality of Communication (QOC) scale. The QOC is a validated self-report instrument. The average composite score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.

  up to 10 days after patient admission, one-time survey for family members

Secondary Outcomes (12)

• Family-reported General Quality of Communication (QOC), within 5-7 days of ICU admission

  up to 10 days after patient admission, one-time survey for family members

• Family-reported End-of-Life (EOL) Quality of Communication (QOC), within 5-7 days of ICU admission

  up to 10 days after patient admission, one-time survey for family members

• Family-reported proportion of Goal Concordant Care (GCC) at 5-7 days post ICU admission

  up to 10 days after patient admission, one-time survey for family members

• Clinician-reported Measure of Moral Distress for Healthcare Professionals (MMD-HP)

  3 months prior to each implementation wave and again 12 months later

• Clinician-reported Emotional Exhaustion (EE) - Maslach Burnout Inventory (MBI)

  3 months prior to each implementation wave and again 12 months later

Other Outcomes (1)

• Practitioner Opinion Survey

  at study completion (estimated up to 2 years)

Study Arms (2)

Best Case/Worst Case-ICU Communication Tool

EXPERIMENTAL

Patients in the intervention group will receive care from a trauma team that routinely uses the Best Case/Worst Case-ICU communication tool.

Other: Best Case/Worst Case-ICU Communication Tool

Usual Care

NO INTERVENTION

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.

Interventions

Best Case/Worst Case-ICU Communication Tool OTHER

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.

Best Case/Worst Case-ICU Communication Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 50 and older
• admitted to the ICU for 3 or more days after serious injury

You may not qualify if:

• none
• Family Members
• aged 18 and older
• patient's family member or informally designated "like family" or primary surrogate decision maker
• speak English or Spanish
• does not have decision-making capacity
• Clinicians
• 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)
• do not provide care in the trauma ICU

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator
• University of Maryland, Baltimore: collaborator
• University of California, Davis: collaborator
• Harborview Injury Prevention and Research Center: collaborator
• Lehigh Valley Health Network: collaborator
• Grady Memorial Hospital: collaborator
• Froedtert Hospital: collaborator
• University of Alabama at Birmingham: collaborator
• Rhode Island Hospital: collaborator
• American College of Surgeons: collaborator
• Coalition for National Trauma Research: collaborator

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California Davis Medical Center

Davis, California, 95616, United States

Location

Grady Memorial Hospital - Morehouse School of Medicine

Atlanta, Georgia, 30314, United States

Location

Shock Trauma - University of Maryland Medical Center

Baltimore, Maryland, 20742, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Rhode Island Hospital - Brown University

Providence, Rhode Island, 02912, United States

Location

Harborview Medical Center - University of Washington

Seattle, Washington, 98195, United States

Location

Froedtert Hospital - Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 39209498 DERIVED

MeSH Terms

Conditions

Communication; Wounds and Injuries

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Margaret L Schwarze, MD, MPP

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster randomized trial, sites randomized to start time. 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.

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 23, 2023
• Study Start: July 1, 2023
• Primary Completion: August 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All de-identified data will be made available within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier.
• Access Criteria: Data housed in NACDA or comparable NIH-supported repository will be restricted and researchers seeking access must complete a Restricted Data Use Agreement required by the repository, including documenting how regulatory requirements at their institution have been met and providing a data security plan. Once the repository receives and approves the agreement, repository staff will send the requestor an encrypted link to obtain the data files.

Locations

US (8)