Communication
Conditions
Keywords
patient decision making, surgical decision making, shared decision making, decision support techniques
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.
Interventions
OTHERBest 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.
Sponsors
National Institute on Aging (NIA)
Oregon Health and Science University
University of Texas Southwestern Medical Center
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Family Member-reported Quality of End of Life Communication (QOC) Received From Study Surgeon | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Nurse-reported Quality of End of Life Communication (QOC) Received From Study Surgeon | 72 hours after trauma unit admission | 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 |
| Family-reported Goal Concordant Care | 10 days after trauma unit admission | 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 |
| Patient-reported Trauma Quality of Life (TQoL) | 30 days after trauma unit admission | 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 |
| Nurse-reported General Quality of Communication (QOC) Received From Study Surgeon | 72 hours after trauma unit admission | 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 |
| Family-reported Care Quality and Bereavement | After death (in substitute for family-reported Family-reported Trauma Quality of Life) | 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 |
| Trauma Nurse-reported Moral Distress | Start of study and 30 months after study commencement | 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 |
| Trauma Physician-reported Moral Distress | Start of study and 30 months after study commencement | 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 |
| Family-reported Trauma Quality of Life (TQoL) | 30 days after trauma unit admission | 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 |
| Family-reported Communication and Care Coordination | 10 days after trauma unit admission | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| Usual Care 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. | 48 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 18 | 0 | 11 | 0 | 0 |
| Overall Study | Unavailable for training | 0 | 0 | 19 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Best Case/Worst Case Communication Tool | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 48 Participants | 78 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 0 Participants | 8 Participants |
| Age, Continuous | 73.2 years STANDARD_DEVIATION 10.76 | 73.8 years STANDARD_DEVIATION 7.25 | 73.4 years STANDARD_DEVIATION 8.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 42 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) White | 34 Participants | 37 Participants | 71 Participants |
| Region of Enrollment United States | 38 participants | 48 participants | 86 participants |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 29 Participants |
| Sex: Female, Male Male | 25 Participants | 32 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 38 | 7 / 48 |
| other Total, other adverse events | 0 / 38 | 0 / 48 |
| serious Total, serious adverse events | 0 / 38 | 0 / 48 |
Outcome results
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Best Case/Worst Case Communication Tool | Family Member-reported General Communication (QOC) Received From Study Surgeon | 8.5 score on a scale | Standard Deviation 1.9 |
| Usual Care | Family Member-reported General Communication (QOC) Received From Study Surgeon | 8.3 score on a scale | Standard Deviation 1.72 |
p-value: 0.709t-test, 2 sided
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Best Case/Worst Case Communication Tool | Family Member-reported Quality of End of Life Communication (QOC) Received From Study Surgeon | 6.6 score on a scale | Standard Deviation 2.6 |
| Usual Care | Family Member-reported Quality of End of Life Communication (QOC) Received From Study Surgeon | 4.5 score on a scale | Standard Deviation 2.5 |
p-value: 0.006t-test, 2 sided
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
Time frame: 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.
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Best Case/Worst Case Communication Tool | Family-reported Communication and Care Coordination | 114.5 score on a scale | Standard Deviation 22.98 |
| Usual Care | Family-reported Communication and Care Coordination | 113.8 score on a scale | Standard Deviation 20.87 |
p-value: 0.892t-test, 2 sided
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
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Best Case/Worst Case Communication Tool | Family-reported Goal Concordant Care | Concordant | 16 Participants |
| Best Case/Worst Case Communication Tool | Family-reported Goal Concordant Care | Discordant | 8 Participants |
| Usual Care | Family-reported Goal Concordant Care | Concordant | 15 Participants |
| Usual Care | Family-reported Goal Concordant Care | Discordant | 7 Participants |
Comparison: Comparison of concordance status by intervention status (outcome by predictor).p-value: >0.99Fisher Exact
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Best Case/Worst Case Communication Tool | Family-reported Trauma Quality of Life (TQoL) | 102.6 score on a scale | Standard Deviation 29.63 |
| Usual Care | Family-reported Trauma Quality of Life (TQoL) | 121.7 score on a scale | Standard Deviation 12.56 |
p-value: 0.042t-test, 2 sided
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Best Case/Worst Case Communication Tool | Nurse-reported General Quality of Communication (QOC) Received From Study Surgeon | 7.7 score on a scale | Standard Deviation 1.96 |
| Usual Care | Nurse-reported General Quality of Communication (QOC) Received From Study Surgeon | 6.7 score on a scale | Standard Deviation 1.97 |
p-value: 0.063t-test, 2 sided
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Best Case/Worst Case Communication Tool | Nurse-reported Quality of End of Life Communication (QOC) Received From Study Surgeon | 6 score on a scale | Standard Deviation 2.79 |
| Usual Care | Nurse-reported Quality of End of Life Communication (QOC) Received From Study Surgeon | 4.1 score on a scale | Standard Deviation 2.3 |
p-value: 0.03t-test, 2 sided
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Best Case/Worst Case Communication Tool | Patient-reported Trauma Quality of Life (TQoL) | 115.3 score on a scale | Standard Deviation 17.91 |
| Usual Care | Patient-reported Trauma Quality of Life (TQoL) | 126.7 score on a scale | Standard Deviation 18.12 |
p-value: 0.188t-test, 2 sided
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Best Case/Worst Case Communication Tool | Trauma Nurse-reported Moral Distress | 79.48 score on a scale | Standard Deviation 47.44 |
| Usual Care | Trauma Nurse-reported Moral Distress | 82.56 score on a scale | Standard Deviation 40.86 |
p-value: 0.698t-test, 2 sided
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Best Case/Worst Case Communication Tool | Trauma Physician-reported Moral Distress | 61.03 score on a scale | Standard Deviation 32.32 |
| Usual Care | Trauma Physician-reported Moral Distress | 51.42 score on a scale | Standard Deviation 24.03 |
p-value: 0.15t-test, 2 sided