A Communication Tool to Improve Communication in the ICU

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Serious Injury, Communication

Intervention / Treatment
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* Other: Best Case/Worst Case-ICU Communication Tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Best Case/Worst Case-ICU Communication Tool<br>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<br>* 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.<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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 | 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. | up to 10 days after patient admission, one-time survey for family members | 
| 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. | 3 months prior to each implementation wave and again 12 months later | 
| 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. | 3 months prior to each implementation wave and again 12 months later | 
| 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. | 3 months prior to each implementation wave and again 12 months later | 
| 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. | 3 months prior to each implementation wave and again 12 months later | 
| 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. | during hospitalization, provided by TQIP at study completion (estimated up to 2 years) | 
| 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. | during hospitalization, provided by TQIP at study completion (estimated up to 2 years) | 
| Patient Time to In-hospital Death | Dichotomous variable (alive or deceased) at hospital discharge | during hospitalization, provided by TQIP at study completion (estimated up to 2 years) | 
| 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). | 6 months after patient admission, provided by TQIP at study completion (estimated up to 2 years) | 
| 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. | during hospitalization, provided by TQIP at study completion (estimated up to 2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care unit, trauma, patient decision making, surgical decision making, shared decision making, decision support techniques