Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients

University of Massachusetts, Worcester

Status: Completed

Conditions: Ischemic Stroke; Traumatic Brain Injury; Intracerebral Hemorrhage

Treatments: Other: Decision Aid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03833375

H00004724/H00015764

5K23HD080971 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Usual Care (n=20)

No Intervention group

Description:

Control: general information about TBI from Center for Disease Control (CDC)/about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association

Decision Aid (n=20)

Experimental group

Description:

Paper Decision aid (share decision making tool) with worksheet for surrogates

Treatment:

Other: Decision Aid