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Clinical Trials/NCT03188055
NCT03188055CompletedNot Applicable

Best Case/Worst Case Trauma Study: A Communication Tool to Assist Severely Injured Older Adults

University of Wisconsin, Madison2 sites in 1 country298 target enrollmentStarted: July 14, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
298
Locations
2
Primary Endpoint
Family Member-reported Quality of End of Life Communication (QOC) Received From Study Surgeon

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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
  • •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:
  • •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.
  • •Inclusion Criteria:
  • •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
  • •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:

Arms & Interventions

Best Case/Worst Case communication tool

Experimental

The patient's enrolled surgeon will have completed training on the Best Case/Worst Case communication tool and will be encouraged to use it with the patient.

Intervention: Best Case/Worst Case communication tool (Other)

Usual Care

No Intervention

Usual care typically includes informed consent and a surgeon-directed deliberative phase in which surgeons present their own evaluation of the trade-offs and goals of the proposed intervention.Usual care also consists of daily updates with patient and family, describing each new problem as it arises and what will be done to treat it, regardless of how this fits into the patient's overall prognosis or health trajectory.

Outcomes

Primary Outcomes

Family Member-reported Quality of End of Life Communication (QOC) Received From Study Surgeon

Time Frame: 72 hours after trauma unit admission

Family member-reported quality of end of life communication will be measured by the 7-item end of life subscale of the Quality of Communication scale. The QOC is a validated self-report instrument. The average score is given with a possible range of 0-10. Higher scores indicate higher perceived quality of end of life communication

Family Member-reported General Communication (QOC) Received From Study Surgeon

Time Frame: 72 hours after trauma unit admission

Family member-reported general quality of end communication will be measured by the 6-item general communication subscale of the Quality of Communication scale. The QOC is a validated self-report instrument. The average score is given with a possible range of 0-10. Higher scores indicate higher perceived quality of communication

Secondary Outcomes

  • Nurse-reported Quality of End of Life Communication (QOC) Received From Study Surgeon(72 hours after trauma unit admission)
  • Trauma Nurse-reported Moral Distress(Start of study and 30 months after study commencement)
  • Family-reported Care Quality and Bereavement(After death (in substitute for family-reported Family-reported Trauma Quality of Life))
  • Family-reported Communication and Care Coordination(10 days after trauma unit admission)
  • Patient-reported Trauma Quality of Life (TQoL)(30 days after trauma unit admission)
  • Trauma Physician-reported Moral Distress(Start of study and 30 months after study commencement)
  • Nurse-reported General Quality of Communication (QOC) Received From Study Surgeon(72 hours after trauma unit admission)
  • Family-reported Goal Concordant Care(10 days after trauma unit admission)
  • Family-reported Trauma Quality of Life (TQoL)(30 days after trauma unit admission)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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