Clinical trial NCT03188055: A Communication Tool to Assist Severely Injured Older Adults
Official title: Best Case/Worst Case Trauma Study: A Communication Tool to Assist Severely Injured Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Keywords: 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: Oregon Health and Science University
name: University of Texas Southwestern Medical Center
First posted: 2017-06-15
Enrollment: 298
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to test the effect of the "Best Case/Worse Case" (BC/WC) communication tool on the quality of communication with older patients admitted to two trauma units. The intervention was developed and tested with acute care surgical patients at the University of Wisconsin (UW) and we are now testing whether the intervention will work in a different setting. We will test the intervention with severely injured older adults at Oregon Health Sciences University (OHSU) and Parkland Memorial Hospital (PMH) at the University of Texas Southwestern (UTS). In the first year, UTS/PMH and OHSU will recruit and enroll 50 patients in the control arm (total, for both sites) and train trauma surgeons to use the best case/worst case tool. In the second year, UTS/PMH and OHSU will recruit and enroll 50 patients in the intervention arm (total, for both sites). UW will compare survey-reported and chart-derived measures before and after clinicians learn to use the best case/worst case tool.

Detailed description: The purpose of this study is to test the effect of the "best case/worse case" communication tool on the quality of communication with older patients admitted to two trauma units and to collect feedback on the tool to help adapt it to the trauma setting. The intervention was developed and tested with acute care surgical patients at the University of Wisconsin (UW) and the present study seeks to test whether the intervention will work in a different setting.

To adapt the tool to trauma settings, we will conduct focus groups at UW Health Oregon Health Sciences University (OHSU) and Parkland Memorial Hospital (PMH) at the University of Texas-Southwestern (UT-S). Because trauma care is delivered by a multidisciplinary team, we will include attending trauma surgeons, surgical residents, ICU nurses, nurse practitioners, consulting physicians (e.g. orthopedic surgeons) and others on the trauma care team. Up to 60 trauma car providers will participate in focus groups across the three sites. We will test the intervention with severely injured older adults at OHSU and UT-S/PMH. In the first year, UT-S/PMH and OHSU will recruit and enroll 50 patients total in the control arm and train trauma surgeons to use the best case/worst case tool. In the second year, UT-S/PMH and OHSU will recruit and enroll 50 patients total in the intervention arm.

UT-S/PMH and OHSU research team members will survey family members of trauma patients to compare the quality of communication for severely injured geriatric trauma patients cared for by trauma teams. When possible, UT-S/PMH and OHSU will survey patients on their quality of life. UT-S/PMH and OHSU will survey the patient's primary nurse on the quality of communication patients and will survey patient's families about their thoughts on the quality of communication as well. UT-S/PMH and OHSU will survey trauma unit staff before and after clinicians learn to use the best case/worst case tool, to assess whether the communication intervention improves feelings of moral distress. UT-S/PMH and OHSU will use chart review to collect downstream clinical outcomes including intensity of treatment and receipt of palliative care. UT-S/PMH and OHSU will archive de-identified graphic aids used by trauma surgeons with intervention patients to explore how the intervention was enacted.

Eligibility criteria: Patients

Inclusion Criteria:

* Traumatically injured patients 50 and older admitted to the ICU

Exclusion Criteria:

* Surgeons will have an opportunity to exclude a patient or family who, in the physician's judgment, would not be an appropriate participant
* Patients with a Physician Orders for Life-Sustaining Medical Treatment (POLST) or Medical Orders for Life-Sustaining Medical Treatment (MOLST) form on file in their medical record that specifies that the patient or their decision maker wishes them to receive no intervention
* Patients with an isolated head injury as defined by a Head Abbreviated Injury Scale (AIS) score of 2 or less and an External AIS score of 1 or 0 and a Glasgow Coma Scale (GCS) score of 15. This serves to exclude the mildly traumatically brain injured patients with minimal external injuries who require ICU-level monitoring for a short period of time only

Family Members

Inclusion Criteria:

* N/A

Exclusion Criteria:

* We will exclude patients whose family members do not speak English
* Under the age of 18
* Lack decision making capacity (DMC)
* Have a severe hearing or vision impairment.

Surgeons

Inclusion Criteria:

-N/A

Exclusion Criteria:

* Care providers who do not directly provide primary trauma care in the ICU
* Residents who have not had at least 5 years of postgraduate training
* Trauma consultants including for example, neurosurgeons, orthopedic surgeons, and otolaryngologists

Nurses

Inclusion Criteria:

* The nurse responsible for care of the enrolled patient at 3 days post-admission will be invited to complete a Quality of Communication (QOC) survey assessment

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Family Member-reported Quality of End of Life Communication (QOC) Received From Study Surgeon
timeFrame: 72 hours after trauma unit admission
measure: Family Member-reported General Communication (QOC) Received From Study Surgeon
timeFrame: 72 hours after trauma unit admission
Secondary outcomes:
measure: Nurse-reported Quality of End of Life Communication (QOC) Received From Study Surgeon
timeFrame: 72 hours after trauma unit admission
measure: Nurse-reported General Quality of Communication (QOC) Received From Study Surgeon
timeFrame: 72 hours after trauma unit admission
measure: Family-reported Communication and Care Coordination
timeFrame: 10 days after trauma unit admission
measure: Family-reported Goal Concordant Care
timeFrame: 10 days after trauma unit admission
measure: Patient-reported Trauma Quality of Life (TQoL)
timeFrame: 30 days after trauma unit admission
measure: Family-reported Trauma Quality of Life (TQoL)
timeFrame: 30 days after trauma unit admission
measure: Family-reported Care Quality and Bereavement
timeFrame: After death (in substitute for family-reported Family-reported Trauma Quality of Life)
measure: Trauma Nurse-reported Moral Distress
timeFrame: Start of study and 30 months after study commencement
measure: Trauma Physician-reported Moral Distress
timeFrame: Start of study and 30 months after study commencement
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: University of Wisconsin, Madison
name: Gretchen Schwarze, MD, MPP, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Karen Brasel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Thomas Shoultz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zimmermann CJ, Zelenski AB, Buffington A, Baggett ND, Tucholka JL, Weis HB, Marka N, Schoultz T, Kalbfell E, Campbell TC, Lin V, Lape D, Brasel KJ, Phelan HA, Schwarze ML. Best case/worst case for the trauma ICU: Development and pilot testing of a communication tool for older adults with traumatic injury. J Trauma Acute Care Surg. 2021 Sep 1;91(3):542-551. doi: 10.1097/TA.0000000000003281.