Feasibility of a Digital Goals-of-Care Decision Aid for Clinicians and Families of Patients With SABI
- Conditions
- Hemorrhagic Stroke, IntracerebralTraumatic Brain InjuryAcute Ischemic Stroke
- Interventions
- Behavioral: Web/mobile/tablet-based digital decision aid + communication (DA+C) tool
- Registration Number
- NCT05671874
- Lead Sponsor
- University of Massachusetts, Worcester
- Brief Summary
The goal is to pilot test a highly accessible, web-based, pragmatic, scalable intervention to overcome ongoing problems with high stakes decision-making by surrogate decision-makers of patients in ICUs with severe acute brain injury (SABI), including those with moderate-severe traumatic brain injury, large hemispheric acute ischemic stroke and intracerebral hemorrhage.
- Detailed Description
Every 30 seconds an adult in the U.S. suffers a severe acute brain injury (SABI) from traumatic brain injury or large ischemic or hemorrhagic stroke, resulting in 200,000 deaths and \>900,000 survivors living with disability annually. Every day, surrogate decision-makers face the difficult "goals of care" decision in intensive care units (ICUs) to continue or withdraw life support while considering the patient's long-term prognosis. In this study, we will pilot test a pragmatic, scalable intervention to overcome ongoing problems with high stakes decision-making by surrogates of patients with SABI in ICUs. These problems are an important target for intervention, because they contribute to 3 major clinical and public health issues: 1) family members struggle in the role of surrogate, leading to lasting symptoms of psychological distress; 2) clinicians are poorly trained in communicating prognosis after SABI, often doing so with variability and bias, inadequately preparing families for their decisions; 3) patients often receive burdensome treatments that they would not choose.
Decision aids improve the quality of patients' decisions based on a large evidence-base, but no empirically validated tools currently exist for surrogate decision-making in SABI patients at high risk for death or disability. This is problematic because surrogates of SABI patients are unprepared for the difficult decisions about the use of life support and patients' potential long-term disability, which hinge on both medical information and the patient's values and preferences. We have developed and refined a tailored digital, web-based decision aid (DA) for families of critically ill SABI patients, conceptually grounded in the Ottawa Decision Support Framework, to enhance, not replace, clinician-family communication. We will leverage a digital platform, which is portable and shareable among family members when geographically distant or not allowed to visit the ICU (as during the COVID-19 pandemic) and allows integration of videos to reach lower-literacy groups. This innovative tool challenges the existing paradigm for decision-making in SABI patients.
This pilot study among 50 surrogates of SABI patients and their clinicians will assess the feasibility of deploying the web-based tool as well as to explore the tools impact on measures of communication and decision-quality.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Web-based Decision Aid + Communication (DA+C) tool Web/mobile/tablet-based digital decision aid + communication (DA+C) tool Surrogate(s) will read/click through the DA+C tool prior to the clinician-family meeting and complete the integrated worksheet. Surrogate(s) will have unlimited access to the DA+C tool and may return to the tool and edit the worksheet at any time.
- Primary Outcome Measures
Name Time Method Feasibility of enrolling surrogates in a stepped-wedge (before/after) clinical trial in a neurocritical care setting Through study completion, estimated 18 months past primary start date Measured by meeting target enrollment.
Feasibility of retaining surrogates in a neurocritical care setting Three-months post SABI The number of subjects that complete the long-term follow-up.
Feasibility of tool use by surrogate decision-makers Duration of ICU stay, an expected average of 4 weeks Data tracking analytics built into the tool will be employed to determine the extent to which the tools is used as per protocol.
- Secondary Outcome Measures
Name Time Method Participants' ratings of perceived effectiveness of the tool in preparing them for decision-making (Intervention surrogates only) Duration of ICU stay, an expected average of 4 weeks Perceived Effectiveness will be measured with an 11-item perceived effectiveness questionnaire using a 5-point Likert scale.
Fidelity to intervention protocol Through study completion, estimated 18 months past primary start date Fidelity to the intervention protocol will be measured using self-checklists by clinicians and review of a random selection of 30% of the audio-recorded clinician-family meetings
Participants' ratings of usability of the tool (Intervention surrogates only) Duration of ICU stay, an expected average of 4 weeks Usability of the tool as measured with the System Usability Scale.
Trial Locations
- Locations (3)
UMass Memorial Hospital
🇺🇸Worcester, Massachusetts, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States