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Active, Not Recruiting

NCT Number: NCT05780918

A Communication Tool to Improve Communication in the ICU

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Serious Injury Behavior Communication Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients

Inclusion criteria

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

Exclusion criteria

  • none

Family Members

Inclusion criteria

  • aged 18 and older
  • patient's family member or informally designated "like family" or primary surrogate decision maker
  • speak English or Spanish

Exclusion criteria

  • does not have decision-making capacity

Clinicians

Inclusion criteria

  • 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

  • do not provide care in the trauma ICU

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

  8. Patient ICU Length of Stay (LOS)

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

    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.

  9. Patient Total Time on Ventilator

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

    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.

  10. Patient Time to In-hospital Death

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

    Dichotomous variable (alive or deceased) at hospital discharge

  11. Patient 6-month Mortality

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

    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).

  12. Patient Time to Withdrawal of Life Supporting Treatment

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

    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.

Other outcomes

  1. Practitioner Opinion Survey

    Time frame: at study completion (estimated up to 2 years)

    To evaluate the implementation of the intervention, trauma surgeons will be asked for their impressions of the Best Case/Worst Case-ICU communication tool using a 12-item questionnaire upon study completion. Each question is measured on an ordinal, 5-point Likert scale where 1 is 'strongly disagree' and 5 is 'strongly agree.'

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 23, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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