Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21AG055876-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Oregon Health and Science University | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Case/Worst Case communication tool | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Patients
Inclusion Criteria:
Exclusion Criteria:
Family Members
Inclusion Criteria:
Exclusion Criteria:
Surgeons
Inclusion Criteria:
-N/A
Exclusion Criteria:
Nurses
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gretchen Schwarze, MD, MPP, FACS | University of Wisconsin, Madison | Principal Investigator |
| Karen Brasel, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Thomas Shoultz, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health Sciences University | Portland | Oregon | 97239-3098 | United States | ||
| University of Texas Southwestern |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34039930 | Derived | Zimmermann CJ, Zelenski AB, Buffington A, Baggett ND, Tucholka JL, Weis HB, Marka N, Schoultz T, Kalbfell E, Campbell TC, Lin V, Lape D, Brasel KJ, Phelan HA, Schwarze ML. Best case/worst case for the trauma ICU: Development and pilot testing of a communication tool for older adults with traumatic injury. J Trauma Acute Care Surg. 2021 Sep 1;91(3):542-551. doi: 10.1097/TA.0000000000003281. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
86 family members enrolled in this study and 43 patients with decision-making capacity (DMC) associated with these family members also enrolled. Baseline characteristics are reported for the patients in both the usual care and intervention arm. For other participants, baseline characteristics were not collected and/or these participant types were not part of the study randomization schema.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 72 hours after trauma unit admission |
|
Up to approximately 30 days following enrollment.
Participants in the pre/post moral distress surveys are not included as their participation was limited to a one-time survey. Participants in the Trauma Care Provider Focus Group, Trauma Team Training and Participant Nurses were also not formally monitored for adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Chart-derived treatment intensity as measured by the Simplified Therapeutic Intervention Scoring System (TISS-28) was removed as an outcome measure as this data was collected inconsistently, considered unreliable and therefore not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Lee Schwarze, MD, MPP, FACS | University of Wisconsin, Madison | (608) 265-2358 | schwarze@surgery.wisc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2019 | Oct 20, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 72 hours after trauma unit admission |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| Dallas |
| Texas |
| 75390 |
| United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | Posted | Count of Participants | Participants | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | Posted | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Start of study and 30 months after study commencement |
|
|
|
|
| 6 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | 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. 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. | 7 | 48 | 0 | 48 | 0 | 48 |
Not provided
Not provided