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Serious InjuryNCT05780918

A Communication Tool to Improve Communication in the ICU

A study testing Best Case/Worst Case-ICU Communication Tool in people with Serious Injury and Communication, run by University of Wisconsin, Madison at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Serious Injury, Communication
What is being tested?
Best Case/Worst Case-ICU Communication Tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,320 participants
Where
8 sitesUnited States
Study dates
1 Jul 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged 50 and older
  • 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)

Who cannot join

  • none
  • Family Members
  • does not have decision-making capacity
  • Clinicians
  • do not provide care in the trauma ICU

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Grady Memorial Hospital - Morehouse School of Medicine

    Atlanta, Georgia, 30314

  • Shock Trauma - University of Maryland Medical Center

    Baltimore, Maryland, 20742

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • University of California Davis Medical Center

    Davis, California, 95616

  • Froedtert Hospital - Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Rhode Island Hospital - Brown University

    Providence, Rhode Island, 02912

  • Harborview Medical Center - University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: A Randomized Clinical Trial of Scenario Planning for Older Adults With Serious Injury

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.

Read the detailed description

This is a multisite, stepped-wedge, randomized clinical trial. At the start of the study, investigators will randomly assign each site to the time when the intervention team will train all trauma surgeons, trainees, and ICU clinicians to use the Best Case/Worst Case-ICU tool. Participants in the intervention group will receive care from a trauma team that routinely uses the Best Case/Worst Case-ICU communication tool. Participants in the control group will receive usual care.

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.
Being tested
Best Case/Worst Case-ICU Communication Tool
Keywords
intensive care unit, trauma, patient decision making, surgical decision making, shared decision making, decision support techniques
Medical subject headings
Communication, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best Case/Worst Case-ICU Communication ToolOther

    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.

Study groups in NCT05780918
Study groupRoleWhat they receive
Best Case/Worst Case-ICU Communication ToolExperimentalPatients admitted to the trauma ICU after implementation of the intervention will receive care from a trauma ICU team trained to routinely use the Best Case/Worst Case-ICU communication tool. Family members will be exposed to the intervention through communication encounters that incorporate daily scenario planning and the Best Case/Worst Case-ICU graphic aid and will be asked to complete a one-time survey assessing quality of communication and goal-concordant care. Clinicians will receive Best Case/Worst Case-ICU training, incorporate the tool into routine communication practices, and complete surveys assessing moral distress and burnout.
Receives: Other: Best Case/Worst Case-ICU Communication Tool
Control (Usual Care)No interventionPatients admitted to the trauma ICU prior to implementation of the intervention will receive usual care and communication from the trauma ICU team. Family members will receive standard communication regarding the patient's condition and treatment and will be asked to complete a one-time survey assessing quality of communication and goal-concordant care. Clinicians will continue their routine communication practices without Best Case/Worst Case-ICU training and will complete surveys assessing moral distress and burnout.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Family-reported Quality of Communication (QOC) Within 5-7 Days of ICU Admission

    Family-reported quality of communication will be measured using the 13-item composite score from the Quality of Communication (QOC) scale, a validated self-report instrument. The average composite score ranges from 0 to 10, with higher scores indicating a higher perceived quality of communication.

    Measured: Intended assessment window was 5-7 days after admission, data collection was permitted up to 10 days after admission, this is a one-time survey for family members

Secondary outcomes (12)

  1. Family-reported General Quality of Communication (QOC), Within 5-7 Days of ICU Admission

    Family-reported general quality of communication will be measured using the 6-item general communication subscale of the 20-item quality of communication (QOC) scale. The QOC is a validated self-report instrument. The average item score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.

    Measured: Intended assessment window was 5-7 days after admission, data collection was permitted up to 10 days after admission, this is a one-time survey for family members

  2. Family-reported End-of-Life (EOL) Quality of Communication (QOC), Within 5-7 Days of ICU Admission

    Family-reported quality of end-of-life communication will be measured using 7-item end-of-life communication subscale of the 20-item Quality of Communication scale. The QOC is a validated self-report instrument. The average item score will be given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication.

    Measured: Intended assessment window was 5-7 days after admission, data collection was permitted up to 10 days after admission, this is a one-time survey for family members

  3. Family-reported Proportion of Goal Concordant Care (GCC) at 5-7 Days Post ICU Admission

    Family-reported goal-concordant care will be assessed by 2 survey questions taken from the SUPPORT study. (Question 1 - Preferences for Care: If you had to make a choice at this time, would you prefer a course of treatment for your loved one that focuses on extending life as much as possible, even if it means having more pain and discomfort, or would you want a plan of care that focuses on relieving pain and discomfort as much as possible, even if that means not living as long? Question 2 - Current Receipt of Care Consistent with Preferences: Would you say that your loved one's current medical care is more focused on extending life as much as possible, even if it means having more pain and discomfort, or on relieving pain and discomfort as much as possible, even if that means not living as long?) If participant gives the same answer to both questions, this will be considered concordant. If the answers to the two questions are different, this will be considered discordant.

    Measured: Intended assessment window was 5-7 days after admission, data collection was permitted up to 10 days after admission, this is a one-time survey for family members

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

    As a proximate measure of the intervention effect on ICU conflict, the investigators will use the Measure of Moral Distress for Health Care Professionals (MMD-HP) to measure center-level distress at the beginning and the end of the study. Frequency and level of distress of clinician experiences are each rated on a 0-4 scale where 0 is 'never' and 4 is 'very frequently' and 0 is 'none' and 4 is 'very distressing,' respectively. The total possible range of scores is 0-432 (the product of the frequency times the level of distress for 27 items) with higher scores indicating more moral distress.

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

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

    Clinician emotional exhaustion will be measured with the Maslach Burnout Inventory - Human Services Survey (MBI-HSS), a 22-item inventory scored on a 7-point Likert scale from 0-6 where 0 is 'never' and 6 is 'everyday'. The EE subscale includes 9 items for a total possible range of scores from 0-54, higher scores indicate increased emotional exhaustion.

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

  6. Clinician-reported Depersonalization (DP) - Maslach Burnout Inventory (MBI)

    Clinician depersonalization will be measured with the Maslach Burnout Inventory - Human Services Survey (MBI-HSS), a 22-item inventory scored on a 7-point Likert scale from 0-6 where 0 is 'never' and 6 is 'everyday'. The DP subscale includes 5 items for a total possible range of scores from 0-30, higher scores indicate increased depersonalization.

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

  7. Clinician-reported Personal Accomplishment (PA) - Maslach Burnout Inventory (MBI)

    Clinician personal accomplishment will be measured with the Maslach Burnout Inventory - Human Services Survey (MBI-HSS), a 22-item inventory scored on a 7-point Likert scale from 0-6 where 0 is 'never' and 6 is 'everyday'. The PA subscale includes 8 items for a total possible range of scores from 0-48, higher scores indicate decreased personal accomplishment.

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

  8. Patient ICU Length of Stay (LOS)

    ICU LOS will be measured as the cumulative amount of time each study qualified patient spent in the ICU during the post-injury hospital admission. Each partial or full day is measured as one calendar day.

    Measured: during hospitalization, provided by TQIP at study completion (estimated up to 2 years)

  9. Patient Total Time on Ventilator

    Patient total time on ventilator will be measured as the cumulative amount of time each study qualified patient spent on a ventilator during the post-injury hospital admission. Each partial or full day is measured as one calendar day.

    Measured: during hospitalization, provided by TQIP at study completion (estimated up to 2 years)

  10. Patient Time to In-hospital Death

    Dichotomous variable (alive or deceased) at hospital discharge

    Measured: during hospitalization, provided by TQIP at study completion (estimated up to 2 years)

  11. Patient 6-month Mortality

    The procedure for death ascertainment at 6 months after admission includes chart review, attempt to reach listed patient contacts, and internet search. Patients without documentation of death will be presumed alive. Dichotomous variable (presumed alive or confirmed deceased).

    Measured: 6 months after patient admission, provided by TQIP at study completion (estimated up to 2 years)

  12. Patient Time to Withdrawal of Life Supporting Treatment

    Withdrawal of life-supporting treatment will be measured as the cumulative amount of time between each study qualified patients' admission and withdrawal of life supporting treatment at the end of life. Each partial or full day is measured as one calendar day.

    Measured: during hospitalization, provided by TQIP at study completion (estimated up to 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2023
  2. Study start1 Jul 2023
  3. Primary completion31 Aug 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
7,320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05780918
Sponsor's protocol ID
2022-0334
Other IDs
R01AG078242-01, Protocol Version 10/10/2025, A539750
Status last verified
Sep 2026
First submitted
10 Mar 2023
Last updated
19 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A de-identified data set comprised of survey data, metadata, and analytic code will be made available through the National Archive of Computerized Data on Aging (NACDA) or comparable NIH-supported repository. A de-identified data set describing the implementation of the intervention will also be made available, including dates of cross-over into the intervention arm, training dates, notes from training sessions, and a data supplement that includes general information about the project that will provide context of the data. This will include a final study protocol, data dictionary, information sheets, and copies of all survey data collection tools. Patient-level data used for this project, originally collected by the Trauma Quality Improvement Program (TQIP) Registry, will not be made available for sharing by the University of Wisconsin. This data is available upon request from the American College of Surgeons (ACS), who administer the TQIP program.

Publications

  • 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.

    PubMed 39209498

Questions about this trial

What is this clinical trial studying?

A study testing Best Case/Worst Case-ICU Communication Tool in people with Serious Injury and Communication, run by University of Wisconsin, Madison at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Family-reported Quality of Communication (QOC) Within 5-7 Days of ICU Admission (time frame: Intended assessment window was 5-7 days after admission, data collection was permitted up to 10 days after admission, this is a one-time survey for family members). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05780918, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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