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Digital Decision Aid + Communication Tool for Hemorrhagic Stroke
N/A
Recruiting
Led By Nils Henninger, MD, PhD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three-months post sabi
Awards & highlights
Study Summary
This trial aims to create a web-based tool to help family members of patients with SABI make decisions in ICUs.
Who is the study for?
This trial is for adult surrogates of critically ill patients with severe acute brain injuries (SABI) like traumatic brain injury or stroke. Surrogates must be English-speaking, literate, and officially recognized as decision-makers. The patient should have a significant risk of death or long-term impairment and not have passed away within the first 3 days after ICU admission.Check my eligibility
What is being tested?
The study tests a digital decision aid plus communication tool designed to help surrogates make care decisions for SABI patients in ICUs. It aims to improve the quality of high-stakes medical decisions by providing accessible web-based support.See study design
What are the potential side effects?
As this intervention involves a digital tool for decision-making rather than medication, traditional physical side effects are not applicable. However, there may be emotional or psychological impacts from using the tool.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three-months post sabi
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three-months post sabi
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of enrolling surrogates in a stepped-wedge (before/after) clinical trial in a neurocritical care setting
Feasibility of retaining surrogates in a neurocritical care setting
Feasibility of tool use by surrogate decision-makers
Secondary outcome measures
Fidelity to intervention protocol
Participants' ratings of perceived effectiveness of the tool in preparing them for decision-making (Intervention surrogates only)
Participants' ratings of usability of the tool (Intervention surrogates only)
Other outcome measures
Caregiver Burden
Decision Regret
Functional status
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Web-based Decision Aid + Communication (DA+C) toolExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
No decision aid
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Who is running the clinical trial?
Johns Hopkins UniversityOTHER
2,262 Previous Clinical Trials
14,823,114 Total Patients Enrolled
University of Massachusetts, WorcesterLead Sponsor
343 Previous Clinical Trials
986,560 Total Patients Enrolled
Worcester Polytechnic InstituteOTHER
16 Previous Clinical Trials
29,829 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- People who have severe illness and pass away within the first 3 days after being admitted.You have a severe brain injury, bleeding in the brain not caused by a tumor or blood vessel problem, or a recent major stroke.You are very sick and need a machine to help you breathe, or you cannot swallow food without a tube.Your doctor thinks there is a high chance (at least 40%) that you could die or have long-term difficulty doing daily activities.You must be 18 years or older to participate, and there is no maximum age limit.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Web-based Decision Aid + Communication (DA+C) tool
- Group 2: Usual Care
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open registrations for this medical experiment?
"Per clinicaltrials.gov, this particular trial is not presently recruiting patients - though it originally opened on the 16th of January in 2023 and was last updated on the 3rd of Janurary that same year. However, there are over 1,300 other trials actively searching for participants right now."
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