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

NCT05671874 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Worcester Polytechnic Institute

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Johns Hopkins University

    collaborator OTHER

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Nils Henninger, MD, PhD · University of Massachusetts, Worcester

  • Susanne Muehlschlegel, MD, MPH · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-28
Primary Completion
2026-03-20
Completion
2026-03-20

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05671874 on ClinicalTrials.gov