A Communication Tool to Assist Severely Injured Older Adults

Communication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188055
• Other study ID #: 2016-1588
• Secondary ID: R21AG055876-01
• Status: Completed
• Phase: N/A
• Start date: July 14, 2017
• Est. completion date: March 3, 2020

Study information

• Verified date: December 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: March 3, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communication

Intervention

Other:
• Best Case/Worst Case communication tool
The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of life-limiting illness. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning our intervention is designed to lead to a discussion of patient preferences and consideration of outcomes. The surgeon verbally describes the "best case," "worst case," and "most likely" outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The surgeon also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences.

Locations

Country	Name	City	State
United States	University of Texas Southwestern	Dallas	Texas
United States	Oregon Health Sciences University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Aging (NIA), Oregon Health and Science University, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family Member-reported Quality of End of Life Communication (QOC) Received From Study Surgeon	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	72 hours after trauma unit admission
Primary	Family Member-reported General Communication (QOC) Received From Study Surgeon	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	72 hours after trauma unit admission
Secondary	Nurse-reported Quality of End of Life Communication (QOC) Received From Study Surgeon	Nurse-reported quality of end of life communication will be measured by the 7-item Quality of Communication scale, end of life subscale, clinician version. 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	72 hours after trauma unit admission
Secondary	Nurse-reported General Quality of Communication (QOC) Received From Study Surgeon	Nurse-reported general quality of communication will be measured by the 6-item Quality of Communication scale, general communication subscale, clinician version. 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 life communication	72 hours after trauma unit admission
Secondary	Family-reported Communication and Care Coordination	Family-reported communication and care coordination as measured by the 30-item Family Inpatient Communication Survey (FICS). The FICS is a validated instrument. Scores on this instrument may range from 30 to 150 and higher scores indicate greater satisfaction with ICU care	10 days after trauma unit admission
Secondary	Family-reported Goal Concordant Care	Family-reported goal concordant care will be assessed by 2 survey questions taken from the SUPPORT study (Question 1: If you had to make a choice at this time, would you prefer a course of treatment for your loved one that focuses on extending life as much as possible, even if it means having more pain and discomfort, or would you want a plan of care that focuses on relieving pain and discomfort as much as possible, even if that means not living as long? Question 2: Would you say that your loved one's current medical care is more focused on extending life as much as possible, even if it means having more pain and discomfort, or on relieving pain and discomfort as much as possible, even if that means not living as long? If participant gave the same answer to both questions, this was considered to be concordant. If the answers to the 2 questions were different, this was considered discordant	10 days after trauma unit admission
Secondary	Patient-reported Trauma Quality of Life (TQoL)	Patient-reported trauma quality of life (TQoL) as measured by the 43 Trauma Quality of Life (TQoL) survey. The TQoL is a validated measure. Scores may range from 41-172. Higher scores indicate better quality of life	30 days after trauma unit admission
Secondary	Family-reported Trauma Quality of Life (TQoL)	Family-reported trauma quality of life (TQoL) as measured by the 43 Trauma Quality of Life (TQoL) survey, adapted for use with family members. The TQoL is a validated measure. Scores may range from 41-172. Higher scores indicate better quality of life	30 days after trauma unit admission
Secondary	Family-reported Care Quality and Bereavement	Family-reported care quality and bereavement as measured by the After-Death Bereaved Family Member Interview, with questions relating to 7 domains of care quality	After death (in substitute for family-reported Family-reported Trauma Quality of Life)
Secondary	Trauma Nurse-reported Moral Distress	Trauma unit staff-reported moral distress will be measured by the 21-item Moral Distress Scale-Revised (MDS-R), nurse version. Scores many range from 0 to 336 and higher scores indicate greater moral distress	Start of study and 30 months after study commencement
Secondary	Trauma Physician-reported Moral Distress	Trauma unit staff-reported moral distress will be measured by the 21-item Moral Distress Scale-Revised (MDS-R), physician version. Scores many range from 0 to 336 and higher scores indicate greater moral distress	Start of study and 30 months after study commencement