Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in SABI, but occurs at a highly variable rate (for example in Traumatic Brain Injury (TBI) 45-89%). Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of SABI patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians. The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S, accounting for more than 200,000 of the acute brain injury-related deaths in the U.S. annually. Patients with SABI are critically ill and most commonly require mechanical ventilation and supportive medical care with artificial nutrition to ensure survival. However, due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is by far the most common cause of death in SABI but occurs at a highly variable rate (for example in TBI 45-90%) at different trauma centers. Shared decision making is a collaborative process that enhances patients' and surrogates' understanding about prognosis, encourages them to actively weigh the risks and benefits of a treatment, and to match them to patient preferences, thereby decreasing decisional conflict and improving decision quality and health related outcomes. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. No DA currently exists for goals-of-care decisions in SABI. Such a patient- and family-centered DA has the potential to improve decision-making for SABI patients by ensuring proxies receive consistent, evidence-based prognostication while also addressing patients' preferences and values. The investigators have developed a pilot DA for goals of care decisions by surrogates of SABI patients using qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians, followed by an iterative feedback process with feedback by surrogates, physicians, and other stakeholders (ICU nurses). The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
41
Shared-decision making tool
Yale Medical School/Yale New Haven Medical Center
New Haven, Connecticut, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Recruitment
Consent rate
Time frame: From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.
Participation
Proportion of participants who read decision aid and completed worksheet
Time frame: 1-36 hours after family meeting
Retention
Number of participants who complete follow-up
Time frame: 3 months
Clinician-surrogate concordance scale score
measures prognostic concordance between ICU clinicians and surrogates. Participants from both groups will independently estimate numerically a SABI patient's 6-month survival and return to independence. Concordance is calculated as the absolute value of the difference in prognosis between the surrogate and the clinician, and, therefore, can range from 0 (no concordance) to 100 (full concordance).
Time frame: Baseline and 1-36 hours after family meeting
Decision Self-Efficacy Scale
is a validated scale that measures self-confidence in making an informed choice using a 5-point Likert scale ranging from 0 (not at all confident) to 4 (very confident).
Time frame: 1-36 hours after family meeting
Decisional Conflict Scale
is a validated scale that measures the personal perception of choosing an option and factors contributing to choice uncertainty. It is a 16-item, 5-item Likert scale with sub-scores for uncertainty, feeling informed, values clarity, decision support and effective decision-making. It ranges from 0 (strongly agree) to 4 (strongly disagree).
Time frame: 1-36 hours after family meeting
AIS/Intracerebral Hemorrhage (ICH)/Traumatic Brain Injury (TBI) knowledge test
Medical knowledge about the goals-of-care decision in SABI will be assessed using the medical knowledge test, which was adapted to 17 questions about goals-of-care and SABI, all of which are addressed in the decision aid. The % correct will be calculated.
Time frame: Baseline and 1-36 hours after family meeting
Hospital Anxiety and Depression Scale (HADS)
is a 14-item, two-domain (depression, anxiety) instrument with reliability and validity among ICU surrogates, which is recommended by consensus guidelines for the prospective measurement of psychological distress among ICU surrogates. Each of the 14 questions are scored between 0 (not at all) and 3 (most of the time), and summed up for a total HADS score, which ranges from 0 to 42, with higher scores indicating worse symptoms. Total HADS 0-7 =normal, 8-10 borderline abnormal, 11-21=abnormal, indicating high anxiety and depression.
Time frame: Baseline,1-36 hours after family meeting, and 3-months
Impact of Events Scale-revised
is a is a validated 15-item instrument, measuring post-traumatic stress disorder (PTSD) symptoms. Total score is the sum of all questions and ranges from 0 to 88, with higher scores indicating worse PTSD symptoms.
Time frame: Baseline,1-36 hours after family meeting, and 3-months
Quality of Communications Scale
is a is a validated 17-item patient-centered instrument widely used in the ICU to assess surrogates' satisfaction of clinician communication about treatments and understanding treatment decisions. It ranges between 0 (poor) to 10 (absolutely perfect). Total score is the sum of all questions and ranges from 0 to 100, with higher scores indicating better communication.
Time frame: 1-36 hours after family meeting
Patient-Perceived Centeredness of Care Scale
is a is a validated 14-item, 4-point Likert scale based test. Its version adapted to surrogates has shown responsiveness in a recent trial of a nurse-driven communication intervention for surrogates in the ICU. It ranges between 1 (very well) to 4 (not at all), and median score is calculated from all questions. Median scores range from 1 to 4, with lower scores indicating more patient- and family-centered care.
Time frame: 1-36 hours after family meeting
Cumulative duration of the goals-of-care family meetings
Investigators will track the duration of each goals-of-care meeting. At the patient's ICU discharge, investigators will sum up the cumulative duration of all goals-of-care meetings \[minutes\].
Time frame: 1-36 hours after family meeting
Total number of goals-of-care family meetings
Investigators will sum up the total number of goals-of-care meetings at the patient's ICU discharge.
Time frame: 1-36 hours after family meeting
Patient's survival status
Investigators will record whether the patient is dead or alive.
Time frame: 3-months after goals of care decision
Patient's Glasgow Outcome Scale
The Glasgow Outcome Score (GOS) is a validated 5-point scale given to traumatic brain injury or other brain injury patients at some point in their recovery. It is a very general assessment of the general functioning of the person who suffered a head injury or other neurological injury. It ranges from 1-5 (higher scores indicating better functional status): 1=death, 2=Vegetative State, 3=Severely Disabled (conscious but the patient requires others for daily support due to disability), 4=Moderately Disabled (the patient is independent but disabled), 5=Good Recovery (the patient has resumed most normal activities but may have minor residual problems).
Time frame: 3-months after goals of care decision
Patient's modified Rankin Scale
is a validated scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It ranges from 0 (no symptoms at all) to 6 (death).
Time frame: 3-months after goals of care decision
Surrogate Decision Regret Scale
is a validated scale that measures distress or remorse after a health care decision with high internal consistency. It asks 5 questions and provides a 5-point Likert scale. It ranges between 1 (strongly agree) to 5 (strongly disagree).
Time frame: 3-months after goals of care decision
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