CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Decision Aidother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03833375
NCT03833375N/ACompleted

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

University of Massachusetts, Worcester·interventional·Posted Feb 7, 2019·Updated Jun 17, 2020

In Brief

A clinical study evaluating Decision Aid for Traumatic Brain Injury and 2 related conditions. Completed, enrolled 41 participants across 2 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 7, 2019
Enrollment StartFeb 11, 2018
Primary CompletionDec 2, 2019
Study CompletionMar 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.4 years ago

Interventions

Decision Aidother

Shared-decision making tool