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Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients

NCT03833375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-06-17

No results posted yet for this study

Summary

Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in SABI, but occurs at a highly variable rate (for example in Traumatic Brain Injury (TBI) 45-89%). Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of SABI patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians. The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.

Conditions

Interventions

OTHER

Decision Aid

Shared-decision making tool

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Dr. Susanne Muehlschlegel, MD, MPH · University of Massachusetts, Worcester

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-11
Primary Completion
2019-12-02
Completion
2020-03-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03833375 on ClinicalTrials.gov