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临床试验/NCT03188055
NCT03188055已完成不适用

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

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2017年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
298
试验地点
2
主要终点
Family Member-reported Quality of End of Life Communication (QOC) Received From Study Surgeon

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion Criteria:
  • •Traumatically injured patients 50 and older admitted to the ICU

排除标准

  • •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:

研究组 & 干预措施

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.

干预措施: 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.

结局指标

主要结局

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

时间窗: 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

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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