Clinical trial NCT03833375: Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients
Official title: Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Ischemic Stroke
Intracerebral Hemorrhage
Keywords: TBI
stroke
ICH
AIS
decision aid
shared decision making
neurocritical care
SABI
surrogate
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Yale University
name: University of Florida
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-02-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, usual-care-controlled feasibility trial comparing decision aid intervention prior to the goals-of-care family meeting to standard of care (no intervention prior to family meeting).
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age; no upper age limit
* Documented health care proxy or legal next of kin of admitted SABI patient with traumatic brain injury, intracerebral hemorrhage or acute ischemic stroke.
* ≥3 days after insult ("stabilization period"); clinical team may ask study team to wait longer if clinically indicated
* SABI 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 SABI 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
Secondary outcomes:
measure: Clinician-surrogate concordance scale score
timeFrame: Baseline and 1-36 hours after family meeting
measure: Decision Self-Efficacy Scale
timeFrame: 1-36 hours after family meeting
measure: Decisional Conflict Scale
timeFrame: 1-36 hours after family meeting
measure: AIS/Intracerebral Hemorrhage (ICH)/Traumatic Brain Injury (TBI) 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: Impact of Events Scale-revised
timeFrame: Baseline,1-36 hours after family meeting, and 3-months
measure: Quality of Communications Scale
timeFrame: 1-36 hours after family meeting
measure: Patient-Perceived Centeredness of Care Scale
timeFrame: 1-36 hours after family meeting
measure: Cumulative duration of the goals-of-care family meetings
timeFrame: 1-36 hours after family meeting
measure: Total number of goals-of-care family meetings
timeFrame: 1-36 hours after family meeting
measure: Patient's survival status
timeFrame: 3-months after goals of care decision
measure: Patient's Glasgow Outcome Scale
timeFrame: 3-months after goals of care decision
measure: Patient's modified Rankin Scale
timeFrame: 3-months after goals of care decision
measure: Surrogate Decision Regret Scale
timeFrame: 3-months after goals of care decision
Other outcomes:
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 Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Dr. Susanne Muehlschlegel, MD, MPH
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: 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: 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: 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.
citation: Muehlschlegel S, Goostrey K, Flahive J, Zhang Q, Pach JJ, Hwang DY. Pilot Randomized Clinical Trial of a Goals-of-Care Decision Aid for Surrogates of Patients With Severe Acute Brain Injury. Neurology. 2022 Oct 3;99(14):e1446-e1455. doi: 10.1212/WNL.0000000000200937.