Clinical trial NCT05780918: A Communication Tool to Improve Communication in the ICU
Official title: A Randomized Clinical Trial of Scenario Planning for Older Adults With Serious Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Serious Injury
Communication
Keywords: intensive care unit
trauma
patient decision making
surgical decision making
shared decision making
decision support techniques
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of Maryland, Baltimore
name: University of California, Davis
name: Harborview Injury Prevention and Research Center
name: Lehigh Valley Health Network
name: Grady Memorial Hospital
name: Froedtert Hospital
name: University of Alabama at Birmingham
name: Rhode Island Hospital
name: American College of Surgeons
name: Coalition for National Trauma Research
First posted: 2023-03-23
Enrollment: 7600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Family-reported Quality of Communication (QOC) within 5-7 days of ICU admission
timeFrame: up to 10 days after patient admission, one-time survey for family members
Secondary outcomes:
measure: Family-reported General Quality of Communication (QOC), within 5-7 days of ICU admission
timeFrame: up to 10 days after patient admission, one-time survey for family members
measure: Family-reported End-of-Life (EOL) Quality of Communication (QOC), within 5-7 days of ICU admission
timeFrame: up to 10 days after patient admission, one-time survey for family members
measure: Family-reported proportion of Goal Concordant Care (GCC) at 5-7 days post ICU admission
timeFrame: up to 10 days after patient admission, one-time survey for family members
measure: Clinician-reported Measure of Moral Distress for Healthcare Professionals (MMD-HP)
timeFrame: 3 months prior to each implementation wave and again 12 months later
measure: Clinician-reported Emotional Exhaustion (EE) - Maslach Burnout Inventory (MBI)
timeFrame: 3 months prior to each implementation wave and again 12 months later
measure: Clinician-reported Depersonalization (DP) - Maslach Burnout Inventory (MBI)
timeFrame: 3 months prior to each implementation wave and again 12 months later
measure: Clinician-reported Personal Accomplishment (PA) - Maslach Burnout Inventory (MBI)
timeFrame: 3 months prior to each implementation wave and again 12 months later
measure: Patient ICU Length of Stay (LOS)
timeFrame: during hospitalization, provided by TQIP at study completion (estimated up to 2 years)
measure: Patient Total Time on Ventilator
timeFrame: during hospitalization, provided by TQIP at study completion (estimated up to 2 years)
measure: Patient Time to In-hospital Death
timeFrame: during hospitalization, provided by TQIP at study completion (estimated up to 2 years)
measure: Patient 6-month Mortality
timeFrame: 6 months after patient admission, provided by TQIP at study completion (estimated up to 2 years)
measure: Patient Time to Withdrawal of Life Supporting Treatment
timeFrame: during hospitalization, provided by TQIP at study completion (estimated up to 2 years)
Other outcomes:
measure: Practitioner Opinion Survey
timeFrame: at study completion (estimated up to 2 years)
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Davis
country: United States
facility: University of California Davis Medical Center
state: California
city: Atlanta
country: United States
facility: Grady Memorial Hospital - Morehouse School of Medicine
state: Georgia
city: Baltimore
country: United States
facility: Shock Trauma - University of Maryland Medical Center
state: Maryland
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital - Brown University
state: Rhode Island
city: Seattle
country: United States
facility: Harborview Medical Center - University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital - Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Margaret L Schwarze, MD, MPP
role: PRINCIPAL_INVESTIGATOR
References: