Trial Outcomes & Findings for A Communication Tool to Assist Severely Injured Older Adults (NCT NCT03188055)

NCT ID: NCT03188055

Last Updated: 2025-11-04

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

298 participants

Primary outcome timeframe

72 hours after trauma unit admission

Results posted on

2025-11-04

Participant Flow

We received 233 survey responses for the anonymous Moral Distress Survey (MDS). As these pre/post surveys were given anonymously, it was not possible to determine the total number of participants as some participants could have completed both pre and post surveys.

Unit of analysis: survey responses

Participant milestones

Participant milestones
Measure
Trauma Care Provider Focus Group
Trauma Care Providers were enrolled in a focus group to assist in developing the intervention, prior to main study and randomization activities.
Usual Care - Control Group
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 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.
Trauma Team Training
Using the best case/worst case training program, a trainer at the UT-S/PMH and OHSU sites trained consenting attending trauma surgeons and trauma team members. As part of the training, participants took part in an assessment session, demonstrating their use of the tool with a standardized patient and scripted clinical scenario.
Best Case/Worst Case Communication Tool
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Participant Nurses
For the nurse-reported Quality of Communication (QoC) surveys, the primary nurse caring for an enrolled study patient was approached by a UT-S/PMH or OHSU research team member during their work shift and asked to participate by filling out a survey that assessed the QoC the patient and family have received over the prior 72 hours. Baseline characteristics were not collected for these participants and they were not randomized.
Moral Distress Survey (MDS) Responses
All nurses and physicians of the trauma units at UT-S/PMH and OHSU were invited to participate in this brief anonymous survey given at two time points: at the start of the study before the first patient is enrolled and at the end of the study, after the last patient is enrolled. These activities occurred prior to and after the main study and randomization activities.
Overall Study
STARTED
48 0
48 0
62 0
38 0
59 0
0 233
Overall Study
Patients Who Provided Self-Consent
0 0
24 0
0 0
19 0
0 0
0 0
Overall Study
MDS Pre-Intervention Survey Responses
0 0
0 0
0 0
0 0
0 0
99 99
Overall Study
MDS Post-Intervention Survey Responses
0 0
0 0
0 0
0 0
0 0
134 134
Overall Study
Patient Survey 1
0 0
16 0
0 0
13 0
0 0
0 0
Overall Study
Nurse Survey 1
0 0
32 0
0 0
27 0
0 0
0 0
Overall Study
Family Survey 1
0 0
37 0
0 0
38 0
0 0
0 0
Overall Study
Family Survey 2
0 0
34 0
0 0
35 0
0 0
0 0
Overall Study
Family Survey 3
0 0
29 0
0 0
26 0
0 0
0 0
Overall Study
COMPLETED
48 0
29 0
43 0
26 0
59 0
0 233
Overall Study
NOT COMPLETED
0 0
19 0
19 0
12 0
0 0
0 0

Reasons for withdrawal

Reasons for withdrawal
Measure
Trauma Care Provider Focus Group
Trauma Care Providers were enrolled in a focus group to assist in developing the intervention, prior to main study and randomization activities.
Usual Care - Control Group
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 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.
Trauma Team Training
Using the best case/worst case training program, a trainer at the UT-S/PMH and OHSU sites trained consenting attending trauma surgeons and trauma team members. As part of the training, participants took part in an assessment session, demonstrating their use of the tool with a standardized patient and scripted clinical scenario.
Best Case/Worst Case Communication Tool
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Participant Nurses
For the nurse-reported Quality of Communication (QoC) surveys, the primary nurse caring for an enrolled study patient was approached by a UT-S/PMH or OHSU research team member during their work shift and asked to participate by filling out a survey that assessed the QoC the patient and family have received over the prior 72 hours. Baseline characteristics were not collected for these participants and they were not randomized.
Moral Distress Survey (MDS) Responses
All nurses and physicians of the trauma units at UT-S/PMH and OHSU were invited to participate in this brief anonymous survey given at two time points: at the start of the study before the first patient is enrolled and at the end of the study, after the last patient is enrolled. These activities occurred prior to and after the main study and randomization activities.
Overall Study
Unavailable for training
0
0
19
0
0
0
Overall Study
Lost to Follow-up
0
18
0
11
0
0
Overall Study
Withdrawal by Subject
0
1
0
1
0
0

Baseline Characteristics

A Communication Tool to Assist Severely Injured Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Best Case/Worst Case Communication Tool
n=38 Participants
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Usual Care
n=48 Participants
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.
Total
n=86 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=15 Participants
0 Participants
n=161 Participants
0 Participants
n=100 Participants
Age, Categorical
Between 18 and 65 years
8 Participants
n=15 Participants
0 Participants
n=161 Participants
8 Participants
n=100 Participants
Age, Categorical
>=65 years
30 Participants
n=15 Participants
48 Participants
n=161 Participants
78 Participants
n=100 Participants
Age, Continuous
73.2 years
STANDARD_DEVIATION 10.76 • n=15 Participants
73.8 years
STANDARD_DEVIATION 7.25 • n=161 Participants
73.4 years
STANDARD_DEVIATION 8.89 • n=100 Participants
Sex: Female, Male
Female
13 Participants
n=15 Participants
16 Participants
n=161 Participants
29 Participants
n=100 Participants
Sex: Female, Male
Male
25 Participants
n=15 Participants
32 Participants
n=161 Participants
57 Participants
n=100 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=15 Participants
3 Participants
n=161 Participants
6 Participants
n=100 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants
n=15 Participants
42 Participants
n=161 Participants
75 Participants
n=100 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=15 Participants
3 Participants
n=161 Participants
5 Participants
n=100 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=15 Participants
2 Participants
n=161 Participants
2 Participants
n=100 Participants
Race (NIH/OMB)
Asian
1 Participants
n=15 Participants
2 Participants
n=161 Participants
3 Participants
n=100 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=15 Participants
0 Participants
n=161 Participants
0 Participants
n=100 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=15 Participants
3 Participants
n=161 Participants
4 Participants
n=100 Participants
Race (NIH/OMB)
White
34 Participants
n=15 Participants
37 Participants
n=161 Participants
71 Participants
n=100 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=15 Participants
0 Participants
n=161 Participants
0 Participants
n=100 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=15 Participants
4 Participants
n=161 Participants
6 Participants
n=100 Participants
Region of Enrollment
United States
38 participants
n=15 Participants
48 participants
n=161 Participants
86 participants
n=100 Participants

PRIMARY outcome

Timeframe: 72 hours after trauma unit admission

Population: Only family members were asked to complete this survey measure (n=86). The number of participants analyzed differs from the number of total family member participants due to survey or item non-response.

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

Outcome measures

Outcome measures
Measure
Best Case/Worst Case Communication Tool
n=25 Participants
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Usual Care
n=26 Participants
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 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.
Family Member-reported Quality of End of Life Communication (QOC) Received From Study Surgeon
6.6 score on a scale
Standard Deviation 2.6
4.5 score on a scale
Standard Deviation 2.5

PRIMARY outcome

Timeframe: 72 hours after trauma unit admission

Population: Only family members were asked to complete this survey measure (n=86). The number of participants analyzed differs from the number of total family member participants due to survey or item non-response.

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

Outcome measures

Outcome measures
Measure
Best Case/Worst Case Communication Tool
n=35 Participants
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Usual Care
n=36 Participants
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 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.
Family Member-reported General Communication (QOC) Received From Study Surgeon
8.5 score on a scale
Standard Deviation 1.9
8.3 score on a scale
Standard Deviation 1.72

SECONDARY outcome

Timeframe: 72 hours after trauma unit admission

Population: Only nurses of study patients were asked to complete this survey measure. The number of participants analyzed differs from the number of total patients (n=86) due to survey or item non-response.

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

Outcome measures

Outcome measures
Measure
Best Case/Worst Case Communication Tool
n=18 Participants
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Usual Care
n=20 Participants
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 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.
Nurse-reported Quality of End of Life Communication (QOC) Received From Study Surgeon
6 score on a scale
Standard Deviation 2.79
4.1 score on a scale
Standard Deviation 2.3

SECONDARY outcome

Timeframe: 72 hours after trauma unit admission

Population: Only nurses of study patients were asked to complete this survey measure. The number of participants analyzed differs from the number of total patients (n=86) due to survey or item non-response.

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

Outcome measures

Outcome measures
Measure
Best Case/Worst Case Communication Tool
n=26 Participants
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Usual Care
n=32 Participants
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 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.
Nurse-reported General Quality of Communication (QOC) Received From Study Surgeon
7.7 score on a scale
Standard Deviation 1.96
6.7 score on a scale
Standard Deviation 1.97

SECONDARY outcome

Timeframe: 10 days after trauma unit admission

Population: The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response. Only family members completed the 30-item Family Inpatient Communication Survey.

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

Outcome measures

Outcome measures
Measure
Best Case/Worst Case Communication Tool
n=35 Participants
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Usual Care
n=33 Participants
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 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.
Family-reported Communication and Care Coordination
114.5 score on a scale
Standard Deviation 22.98
113.8 score on a scale
Standard Deviation 20.87

SECONDARY outcome

Timeframe: 10 days after trauma unit admission

Population: Only family members were asked to complete this survey measure (n=86). The number of participants analyzed differs from the number of total family member participants due to survey or item non-response.

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

Outcome measures

Outcome measures
Measure
Best Case/Worst Case Communication Tool
n=24 Participants
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Usual Care
n=22 Participants
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 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.
Family-reported Goal Concordant Care
Concordant
16 Participants
15 Participants
Family-reported Goal Concordant Care
Discordant
8 Participants
7 Participants

SECONDARY outcome

Timeframe: 30 days after trauma unit admission

Population: Only patients with decision making capacity at time of consent (n=43) were asked to complete this survey measure. The number of participants analyzed differs from the number of total patient participants due to survey or item non-response and changes in decision making capacity after consenting.

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

Outcome measures

Outcome measures
Measure
Best Case/Worst Case Communication Tool
n=10 Participants
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Usual Care
n=9 Participants
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 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.
Patient-reported Trauma Quality of Life (TQoL)
115.3 score on a scale
Standard Deviation 17.91
126.7 score on a scale
Standard Deviation 18.12

SECONDARY outcome

Timeframe: 30 days after trauma unit admission

Population: Only family members were asked to complete this survey measure (n=86). The number of participants analyzed differs from the number of total family member participants due to survey or item non-response.

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

Outcome measures

Outcome measures
Measure
Best Case/Worst Case Communication Tool
n=14 Participants
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Usual Care
n=11 Participants
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 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.
Family-reported Trauma Quality of Life (TQoL)
102.6 score on a scale
Standard Deviation 29.63
121.7 score on a scale
Standard Deviation 12.56

SECONDARY outcome

Timeframe: After death (in substitute for family-reported Family-reported Trauma Quality of Life)

Population: The number of participants analyzed differs from the number of total arm participants because this survey was only offered to family member participants of patients who died on study. Data was collected from 3 participants before the measure was dropped due to high participant emotional burden. Data from the 3 participants was not analyzed due to high item missingness and participant confusion and distress about survey items.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Start of study and 30 months after study commencement

Population: The number of participants analyzed differs from the number of total arm participants because this study activity is not associated with the registered arms; it was a pre/post instrument given at the start/end of the study to all trauma nurses present in the ICU at each of these timepoints.

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

Outcome measures

Outcome measures
Measure
Best Case/Worst Case Communication Tool
n=52 Participants
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Usual Care
n=86 Participants
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 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.
Trauma Nurse-reported Moral Distress
79.48 score on a scale
Standard Deviation 47.44
82.56 score on a scale
Standard Deviation 40.86

SECONDARY outcome

Timeframe: Start of study and 30 months after study commencement

Population: The number of participants analyzed differs from the number of total arm participants because this study activity is not associated with the registered arms; it was a pre/post instrument given at the start/end of the study to all trauma physicians present in the ICU at each of these timepoints.

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

Outcome measures

Outcome measures
Measure
Best Case/Worst Case Communication Tool
n=38 Participants
The patient's enrolled surgeon completed training on the Best Case/Worst Case communication tool and was encouraged to use it with the patient. 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.
Usual Care
n=36 Participants
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 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.
Trauma Physician-reported Moral Distress
61.03 score on a scale
Standard Deviation 32.32
51.42 score on a scale
Standard Deviation 24.03

Adverse Events

Best Case/Worst Case Communication Tool

Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margaret Lee Schwarze, MD, MPP, FACS

University of Wisconsin, Madison

Phone: (608) 265-2358

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place