Clinical trial NCT04143113: Decision Aid Feasibility Trial for Families of Critically Ill Stroke Patients
Official title: Feasibility Trial of a Goals of Care Decision Aid for Families of Critically Ill Stroke Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ischemic Stroke
Ischaemic Stroke With Coma
Intracerebral Hemorrhage
Hemorrhagic Stroke
Keywords: 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
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2019-10-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Step-wedge design
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment
timeFrame: 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.
measure: Participation
timeFrame: 1-36 hours after family meeting
measure: Retention
timeFrame: 3 months after goals-of-care decision
Secondary outcomes:
measure: Impact of Events Scale-revised
timeFrame: Baseline, 1-36 hours after family meeting, and 3-months after goals-of-care decision
measure: Patient-Perceived Centeredness of Care Scale
timeFrame: 1-36 hours after family meeting
Other outcomes:
measure: Decisional Conflict Scale
timeFrame: 1-36 hours after family meeting
measure: Surrogate Decision Regret Scale
timeFrame: 3-months after goals of care decision
measure: Clinician-surrogate concordance scale score
timeFrame: Baseline and 1-36 hours after family meeting
measure: AIS/Intracerebral Hemorrhage (ICH) knowledge test
timeFrame: Baseline and 1-36 hours after family meeting
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline,1-36 hours after family meeting, and 3-months
measure: Quality of Communications Scale
timeFrame: 1-36 hours after family meeting
measure: Total number of goals-of-care family meetings
timeFrame: Through discharge from hospital, an average of 4 weeks
measure: Cumulative duration of the goals-of-care family meetings
timeFrame: Through discharge from hospital, an average of 4 weeks
measure: Patient's survival status
timeFrame: 3-months after goals of care decision
measure: Patient's modified Rankin Scale
timeFrame: 3-months after goals of care decision
Locations:
city: New Haven
country: United States
facility: Yale Medical School/Yale New Haven Medical Center
state: Connecticut
city: Worcester
country: United States
facility: University of Massachusetts, Worcester
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Suzanne Muehlschlegel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quinn T, Moskowitz J, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. What Families Need and Physicians Deliver: Contrasting Communication Preferences Between Surrogate Decision-Makers and Physicians During Outcome Prognostication in Critically Ill TBI Patients. Neurocrit Care. 2017 Oct;27(2):154-162. doi: 10.1007/s12028-017-0427-2.
citation: Muehlschlegel S, Shutter L, Col N, Goldberg R. Decision Aids and Shared Decision-Making in Neurocritical Care: An Unmet Need in Our NeuroICUs. Neurocrit Care. 2015 Aug;23(1):127-30. doi: 10.1007/s12028-014-0097-2.
citation: Moskowitz J, Quinn T, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. Should We Use the IMPACT-Model for the Outcome Prognostication of TBI Patients? A Qualitative Study Assessing Physicians' Perceptions. MDM Policy Pract. 2018 Mar 26;3(1):2381468318757987. doi: 10.1177/2381468318757987. eCollection 2018 Jan-Jun.
citation: Khan MW, Muehlschlegel S. Shared Decision Making in Neurocritical Care. Neurol Clin. 2017 Nov;35(4):825-834. doi: 10.1016/j.ncl.2017.06.014.
citation: Cai X, Robinson J, Muehlschlegel S, White DB, Holloway RG, Sheth KN, Fraenkel L, Hwang DY. Patient Preferences and Surrogate Decision Making in Neuroscience Intensive Care Units. Neurocrit Care. 2015 Aug;23(1):131-41. doi: 10.1007/s12028-015-0149-2.