Decision Aid Feasibility Trial for Families of Critically Ill Stroke Patients

Study Overview
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Brief Summary
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Severe strokes, including large artery acute ischemic stroke and intracerebral hemorrhage, 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 severe strokes, but occurs at a highly variable rate. 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 severe, critically ill stroke patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of traumatic brain injury patients and physicians, and adapted to severe strokes. The investigators now propose to pilot-test a DA for surrogates of critically ill severe stroke patients in a feasibility trial.

Detailed Description
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Severe strokes, including large artery acute ischemic stroke and intracerebral hemorrhage, 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 severe strokes 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 severe strokes but occurs at a highly variable rate at different stroke 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 critically ill severe stroke patients. Such a patient- and family-centered DA has the potential to improve decision-making for critically ill severe stroke 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 critically ill severe stroke patients using qualitative research using semi-structured interviews in surrogate decision makers of traumatic brain injury patients and physicians, followed by an iterative feedback process with feedback by surrogates, physicians, and other stakeholders (ICU nurses), and adaptation to large artery acute ischemic and hemorrhagic stroke. The investigators now propose to pilot-test a DA for surrogates of critically ill severe stroke patients in a feasibility trial.

Official Title
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Feasibility Trial of a Goals of Care Decision Aid for Families of Critically Ill Stroke Patients

Conditions
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Ischemic Stroke, Ischaemic Stroke With Coma, Intracerebral Hemorrhage, Hemorrhagic Stroke

Intervention / Treatment
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* Other: Decision Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age; no upper age limit Documented health care proxy or legal next of kin of severe stroke patient admitted to the ICU with intracerebral hemorrhage or acute ischemic stroke. ≥3 days after insult (stabilization period); clinical team may ask study team to wait longer if clinically indicated Severe stroke patient remains critically ill after 3 days defined as: either intubated and mechanically ventilated, or unable to swallow, needing feeding tube beyond hospital discharge (even if not intubated) Surrogate is physically present in ICU to receive decision aid and participate in planned family meeting in person (not over phone) Exclusion Criteria: Devastating severe stroke patient near death Patient will be extubated and pass swallow evaluation (as deemed by clinical team) Surrogate is non-English speaking and no interpreter available to translate decision aid (no available validated, translated decision aid version) Surrogate is illiterate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Step-wedge design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care (n=20)<br>Control: general information about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association | |
| Experimental: Decision Aid (n=20)<br>Paper Decision aid (share decision making tool) with worksheet for surrogates | Other: Decision Aid<br>* Shared decision making tool<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Consent rate | 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 | 1-36 hours after family meeting | 
| Retention | Number of participants who complete follow-up | 3 months after goals-of-care decision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 1-36 hours after family meeting, and 3-months after goals-of-care decision | 
| 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. | 1-36 hours after family meeting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, hemorrhagic stroke, shared decision making, neurocritical care, decision aid, goals of care, palliative care, family communication, end of life, critical care, neuroICU, patient-centered care