Feasibility of a Digital Goals-of-Care Decision Aid for Clinicians and Families of Patients With SABI

Traumatic Brain Injury Clinical Trial

Official title:

Pilot Trial of a Web/Mobile/Tablet-based Communication and Goals-of-Care Decision Aid for Clinicians and Families of Severe Acute Brain Injury Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671874
• Other study ID #: H00024195
• Secondary ID: R21NR020231
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: University of Massachusetts, Worcester
• Contact: Susanne Muehlschlegel, MD, MPH
• Phone: (617)866-8289
• Email: susanne.muehlschlegel[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria for surrogates and patients:

• surrogate is age 18 years or older, no upper age limit;

• documented surrogate decision-maker (official health care proxy, or legal next of kin) of a critically ill severe acute brain injury (SABI) patient = 3 days after admission;

• patient is age 18 years or older, no upper age limit;

• patient has SABI; defined as either traumatic brain injury, spontaneous primary intracerebral hemorrhage (not due to tumor or vascular malformation), or hemispheric acute ischemic stroke;

• patient is"critically ill" defined as either intubated on a mechanical ventilator, or unable to swallow without a feeding tube (even if not intubated/ventilated);

• patient is judged by the attending physician to have =40% risk of death or long-term functional impairment, elicited by asking the attending physician, "does this patient have at least a 40% chance of in-hospital mortality or long-term functional impairment?", defined as needing assistance with at least 1 activity of daily living (ADL).

• patient has undergone initial stabilization but remains critically ill;

• surrogate will participate in clinician-family goals of care meeting, either in person or via video- or telephone-conference.

• surrogate must be English speaking and literate

Exclusion Criteria for surrogates and patients:

• devastating patients with severe SABI who die early (within the first 3 days after admission);

• surrogate decision-maker is non-English speaking;

• surrogate decision-maker is illiterate.

Inclusion criteria for clinicians:

• clinical treating attending, or physician trainee (fellow, resident), or licensed affiliated practitioner who will lead the clinician-family meeting when goals-of-care are discussed;

• clinician may decline participation in the outcome measures but cannot restrict the surrogate decision-maker in study participation.

Exclusion criteria for clinicians:

• unwillingness to comply with study protocol.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Brain Injuries
• Brain Injuries, Traumatic
• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Traumatic Brain Injury

Intervention

Behavioral:
• Web/mobile/tablet-based digital decision aid + communication (DA+C) tool
The web/mobile/tablet-based digital DA+C toll is designed to enhance communication and shared decision making between clinicians and surrogates of critically ill severe acute brain injury (SABI) with four goals: to 1) prepare families for their surrogate role and discussions with clinicians; 2) provide balanced information to families on prognosis and all available treatment options; 3) provide tailored information about the patient and family to clinicians in advance of family meetings; and 4) serve as a communication guide for clinicians in the clinician-family meeting to facilitate shared decision-making.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	UMass Memorial Hospital	Worcester	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Johns Hopkins University, National Institute of Nursing Research (NINR), National Institutes of Health (NIH), Worcester Polytechnic Institute

Country where clinical trial is conducted

United States, 

References & Publications (5)

Goostrey K, Muehlschlegel S. Prognostication and shared decision making in neurocritical care. BMJ. 2022 Apr 7;377:e060154. doi: 10.1136/bmj-2021-060154. — View Citation

Goostrey KJ, Lee C, Jones K, Quinn T, Moskowitz J, Pach JJ, Knies AK, Shutter L, Goldberg R, Mazor KM, Hwang DY, Muehlschlegel S. Adapting a Traumatic Brain Injury Goals-of-Care Decision Aid for Critically Ill Patients to Intracerebral Hemorrhage and Hemispheric Acute Ischemic Stroke. Crit Care Explor. 2021 Mar 9;3(3):e0357. doi: 10.1097/CCE.0000000000000357. eCollection 2021 Mar. — View 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. — View Citation

Muehlschlegel S, Hwang DY, Flahive J, Quinn T, Lee C, Moskowitz J, Goostrey K, Jones K, Pach JJ, Knies AK, Shutter L, Goldberg R, Mazor KM. Goals-of-care decision aid for critically ill patients with TBI: Development and feasibility testing. Neurology. 2020 Jul 14;95(2):e179-e193. doi: 10.1212/WNL.0000000000009770. Epub 2020 Jun 17. — View Citation

Muehlschlegel S, Perman SM, Elmer J, Haggins A, Teixeira Bailey ND, Huang J, Jansky L, Kirchner J, Kasperek-Wynn R, Lipman PD, Yeatts SD, Fetters MD, Dickert NW, Silbergleit R. The Experiences and Needs of Families of Comatose Patients After Cardiac Arrest and Severe Neurotrauma: The Perspectives of National Key Stakeholders During a National Institutes of Health-Funded Workshop. Crit Care Explor. 2022 Mar 4;4(3):e0648. doi: 10.1097/CCE.0000000000000648. eCollection 2022 Mar. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participants' ratings of what they liked and disliked about the DA+C tool (Intervention surrogates only)	Measured by two open ended questions from the Acceptability Scale.	Until right before the scheduled clinician-family meeting, an average of 10-14 days after admission
Other	Surrogates' clarity about patient values & preferences	We will apply the 3-item Values Clarity Subscale of the Decisional Conflict Scale.	After the scheduled clinician-family meeting, an average of 10-14 days after admission
Other	Surrogates' ratings of the degree of shared decision-making	We will apply six questions from Quality of Communication Scale pertaining to shared decision-making.	After the scheduled clinician-family meeting, an average of 10-14 days after admission
Other	Caregiver Burden	Measured with the 5-item short form of the Caregiver Burden Scale.	Three-months post SABI
Other	Decision Regret	Measured using the Decision Regret Scale.	Three-months post SABI
Other	Goals-of-care decision	Final goals-of-care decision by surrogates (survival vs. withdrawal of life sustaining treatments)	Hospital discharge up until 3-months post SABI
Other	Mortality	Patient death	Hospital discharge up until 3-months post SABI
Other	Functional status	We will measure basic activities of daily living with the Glasgow Outcome Scale Extended (GOSE; range 1-8) and the modified Rankin Scale (range 0-6)	3-months post SABI
Other	Patient-perceived Patient- Centeredness of Care	To assess patient centeredness of care adapted for use by surrogates	3-months post SABI
Primary	Feasibility of tool use by surrogate decision-makers	Data tracking analytics built into the tool will be employed to determine the extent to which the tools is used as per protocol.	Duration of ICU stay, an expected average of 4 weeks
Primary	Feasibility of enrolling surrogates in a stepped-wedge (before/after) clinical trial in a neurocritical care setting	Measured by meeting target enrollment.	Through study completion, estimated 18 months past primary start date
Primary	Feasibility of retaining surrogates in a neurocritical care setting	The number of subjects that complete the long-term follow-up.	Three-months post SABI
Secondary	Participants' ratings of usability of the tool (Intervention surrogates only)	Usability of the tool as measured with the System Usability Scale.	Duration of ICU stay, an expected average of 4 weeks
Secondary	Participants' ratings of perceived effectiveness of the tool in preparing them for decision-making (Intervention surrogates only)	Perceived Effectiveness will be measured with an 11-item perceived effectiveness questionnaire using a 5-point Likert scale.	Duration of ICU stay, an expected average of 4 weeks
Secondary	Fidelity to intervention protocol	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	Through study completion, estimated 18 months past primary start date