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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury; Acute Ischemic Stroke; Hemorrhagic Stroke, Intracerebral
• Intervention / Treatment: Behavioral: Web/mobile/tablet-based digital decision aid + communication (DA+C) tool

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susanne Muehlschlegel, MD, MPH; Phone Number: (617)866-8289; Email: susanne.muehlschlegel@umassmed.edu
• Study Contact Backup: Name: Susanne Muehlschlegel, MD, MPH; Phone Number: (410)502-6534; Email: smuehlsch@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Not yet recruiting
      • Johns Hopkins Bayview Medical Center
      • Principal Investigator: Susanne Muehlschlegel, MD, MPH
      • Contact: Susanne Muehlschlegel, MD, MPH; Email: smuehlsch@gmail.com
      • Contact: Aqsa Khan, BS; Phone Number: (443) 985-5330; Email: akhan144@jh.edu
    • Baltimore, Maryland, United States, 21287
      • Not yet recruiting
      • Johns Hopkins Hospital
      • Principal Investigator: Susanne Muehlschlegel, MD, MPH
      • Contact: Aqsa Khan, BS; Phone Number: (443) 985-5330; Email: akhan144@jh.edu
      • Contact: Susanne Muehlschlegel, MD, MPH; Phone Number: 410-955-2109; Email: smuehlsch@jhu.edu
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • UMass Memorial Hospital
      • Contact: Veronica Peschansky, MD, PhD; Email: veronica.peschansky@umassmemorial.org
      • Contact: Charles J. Hill, BS; Phone Number: (609) 254-5233; Email: charles.hill6@umassmed.edu
      • Principal Investigator: Nils Henninger, MD, PhD
      • Sub-Investigator: Veronica Peschansky, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Web-based 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.	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.
No Intervention: Usual Care; No decision aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Caregiver Burden	Measured with the 5-item short form of the Caregiver Burden Scale.	Three-months post SABI
Decision Regret	Measured using the Decision Regret Scale.	Three-months post SABI
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
Mortality	Patient death	Hospital discharge up until 3-months post SABI
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
Patient-perceived Patient- Centeredness of Care	To assess patient centeredness of care adapted for use by surrogates	3-months post SABI

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Johns Hopkins University; National Institute of Nursing Research (NINR); National Institutes of Health (NIH); Worcester Polytechnic Institute
• Investigators: Principal Investigator: Nils Henninger, MD, PhD, University of Massachusetts Chan Medical School; Principal Investigator: Susanne Muehlschlegel, MD, MPH, Johns Hopkins University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: shared decision making; decision aid; neurocritical care; physician-family communication; withdrawal of life sustaining therapies; patient-value congruent care; neuroICU
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Stroke; Ischemic Stroke; Brain Injuries; Brain Injuries, Traumatic; Hemorrhagic Stroke
• Other Study ID Numbers: H00024195; R21NR020231 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data not published within the final manuscript will be made available by request from any qualified investigator.
• IPD Sharing Time Frame: After publication of the main manuscript up until 5 years after publication.
• IPD Sharing Access Criteria: Requests should be made to the principal investigator susanne.muehlschlegel[at]umassmed.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No