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

NCT05671874 | Completed

• 2 other identifiers: H00024195R21NR020231
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Ischemic Stroke; Traumatic Brain Injury; Hemorrhagic Stroke, Intracerebral

Keywords

shared decision making; physician-family communication; withdrawal of life sustaining therapies; patient-value congruent care; decision aid; neuroICU; neurocritical care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Participants' ratings of usability of the tool (Intervention surrogates only)

  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)

  Duration of ICU stay, an expected average of 4 weeks

• Fidelity to intervention protocol

  Through study completion, estimated 18 months past primary start date

Other Outcomes (9)

• Participants' ratings of what they liked and disliked about the DA+C tool (Intervention surrogates only)

  Until right before the scheduled clinician-family meeting, an average of 10-14 days after admission

• Surrogates' clarity about patient values & preferences

  After the scheduled clinician-family meeting, an average of 10-14 days after admission

• Surrogates' ratings of the degree of shared decision-making

  After the scheduled clinician-family meeting, an average of 10-14 days after admission

Study Arms (2)

Web-based Decision Aid + Communication (DA+C) tool

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

No decision aid

Interventions

Web/mobile/tablet-based digital decision aid + communication (DA+C) tool BEHAVIORAL

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.

Web-based Decision Aid + Communication (DA+C) tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• \- unwillingness to comply with study protocol.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Worcester Polytechnic Institute: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator
• Johns Hopkins University: collaborator

Study Sites (3)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

UMass Memorial Hospital

Worcester, Massachusetts, 01655, United States

Location

Related Publications (5)

• 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.

  PMID: 35853748 BACKGROUND

• 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.

  PMID: 33786434 BACKGROUND

• 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.

  PMID: 35265851 BACKGROUND

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

  PMID: 35696329 BACKGROUND

• 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.

  PMID: 32554766 BACKGROUND

MeSH Terms

Conditions

Hemorrhagic Stroke; Ischemic Stroke; Brain Injuries, Traumatic

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Nils Henninger, MD, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

• Susanne Muehlschlegel, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology (Neurocritical Care)

Model Details: stepped-wedge randomized trial (before-after study)

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: March 28, 2023
• Primary Completion: March 20, 2026
• Study Completion: March 20, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After publication of the main manuscript up until 5 years after publication.
• Access Criteria: Requests should be made to the principal investigator smuehlsch\[at\]jhu.edu

Locations

US (3)