A Communication Tool to Improve Communication in the ICU
- Conditions
- Serious InjuryCommunication
- Interventions
- Other: Best Case/Worst Case-ICU Communication Tool
- Registration Number
- NCT05780918
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 7600
- aged 50 and older
- admitted to the ICU for 3 or more days after serious injury
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Best Case/Worst Case-ICU Communication Tool 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.
- Primary Outcome Measures
Name Time Method Family-reported 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 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 Outcome Measures
Name Time Method Patient Total Time on Ventilator 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.
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 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.
Patient ICU Length of Stay (LOS) 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.
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 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.
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 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.
Clinician-reported Emotional Exhaustion (EE) - Maslach Burnout Inventory (MBI) 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.
Clinician-reported Depersonalization (DP) - Maslach Burnout Inventory (MBI) 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.
Clinician-reported Measure of Moral Distress for Healthcare Professionals (MMD-HP) 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.
Clinician-reported Personal Accomplishment (PA) - Maslach Burnout Inventory (MBI) 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.
Patient 6-month Mortality 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).
Patient Time to In-hospital Death during hospitalization, provided by TQIP at study completion (estimated up to 2 years) Dichotomous variable (alive or deceased) at hospital discharge
Patient Time to Withdrawal of Life Supporting Treatment 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.
Trial Locations
- Locations (8)
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
Rhode Island Hospital - Brown University
🇺🇸Providence, Rhode Island, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Harborview Medical Center - University of Washington
🇺🇸Seattle, Washington, United States
Froedtert Hospital - Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States