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ICU Communication Tool for Serious Injury
N/A
Waitlist Available
Led By Margaret L Schwarze, MD, MPP
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion (estimated up to 2 years)
Awards & highlights
Study Summary
This trial will study the effects of a communication tool on older adults in the ICU with traumatic injury. Clinicians, family members, and 4500 patients at 8 sites will be surveyed.
Who is the study for?
This trial is for older adults aged 50 or above who have been seriously injured and are staying in the ICU for at least three days. It's not specified, but typically people with certain medical conditions or treatments that could interfere with the study may be excluded.Check my eligibility
What is being tested?
The study is testing a communication tool called Best Case/Worst Case-ICU to see if it improves how doctors talk about care, reduces stress on clinicians, and possibly shortens ICU stays. The trial will involve patients from multiple hospitals across the country.See study design
What are the potential side effects?
Since this trial involves a communication tool rather than a medication or medical procedure, there aren't traditional side effects. However, participants might experience emotional or psychological impacts from discussions about their care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study completion (estimated up to 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion (estimated up to 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Family-reported Quality of Communication (QOC) within 5-7 days of ICU admission
Secondary outcome measures
Clinician-reported Depersonalization (DP) - Maslach Burnout Inventory (MBI)
Clinician-reported Emotional Exhaustion (EE) - Maslach Burnout Inventory (MBI)
Clinician-reported Measure of Moral Distress for Healthcare Professionals (MMD-HP)
+9 moreOther outcome measures
Practitioner Opinion Survey
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Best Case/Worst Case-ICU Communication ToolExperimental Treatment1 Intervention
Patients in the intervention group will receive care from a trauma team that routinely uses the Best Case/Worst Case-ICU communication tool.
Group II: Usual CareActive Control1 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.
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,159,787 Total Patients Enrolled
7 Trials studying Communication
9,079 Patients Enrolled for Communication
National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
27,997,464 Total Patients Enrolled
5 Trials studying Communication
993 Patients Enrolled for Communication
Shock Trauma - University of Maryland Medical CenterUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My family member cannot make their own health decisions.I am a family member or considered 'like family' to the patient, over 18, and speak English or Spanish.I am 50 or older and was in the ICU for 3+ days after a serious injury.
Research Study Groups:
This trial has the following groups:- Group 1: Best Case/Worst Case-ICU Communication Tool
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently being recruited for this clinical research?
"The public clinicaltrials.gov website confirms that this particular trial is no longer recruiting participants, with the initial posting on July 1st 2023 and last edit on March 10th 2023. However, there are numerous other trials currently seeking patients."
Answered by AI
Are there numerous locations in North America that are running this research endeavor?
"At this moment, 8 trial sites exist throughout the United States; Davis, Atlanta and Baltimore are just a few. Choosing a location that minimizes commute time is beneficial for potential participants."
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