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Shared Decision Making Intervention for Healthcare Inequalities
N/A
Recruiting
Led By Deepshikha Ashana, M.D.
Research Sponsored by Duke University
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 through study completion, up to 1 year
Awards & highlights
Study Summary
This trial tests an intervention to help ICU clinicians talk with patients' families to reduce racial disparities in healthcare decisions.
Who is the study for?
This trial is for ICU physicians with recent service time and families of non-Hispanic Black or White patients over 18, who are on mechanical ventilation for at least a week. The patient's family must be involved in decision-making and fluent in English. Excluded are cases expecting extubation or death within a day, prisoners, pregnant women, those awaiting transplants, without family decision-makers, or with chronic neuromuscular disease.Check my eligibility
What is being tested?
The study tests the effectiveness of a 'shared decision making tip sheet' designed to help ICU clinicians better involve families in treatment decisions for patients with acute respiratory failure. It aims to reduce racial disparities in these critical conversations.See study design
What are the potential side effects?
Since this trial involves an educational intervention rather than medication, there are no direct medical side effects expected from using the shared decision making tip sheet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Demand for the intervention measured by the proportion of physicians who viewed the intervention
Fidelity to intervention measured by proportion of tip sheet phrases used by physicians
Intervention acceptability as measured by single Likert-scaled item completed by physicians
+3 moreSecondary outcome measures
Components of shared decision making, as measured by content analysis of family meeting recordings
Decisional conflict among families, measured by Decisional Conflict Scale
Decisional regret among families, measured by Decision Regret Scale
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ICU PhysiciansExperimental Treatment1 Intervention
Physicians will view a tip sheet containing information about best practices of shared decision making with diverse individuals. Physicians will then conduct routine meetings with families of patients with acute respiratory failure.
Group II: Family Members of patients in the ICUActive Control1 Intervention
Family members will join routine meetings with the physicians treating with their critically ill loved ones.
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,851,974 Total Patients Enrolled
Duke UniversityLead Sponsor
2,364 Previous Clinical Trials
3,420,492 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,700 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to make my own medical decisions.I am expected to be taken off a ventilator or pass away within the next day.I am 18 years old or older.I have been on a mechanical ventilator for 4 or more days.I am currently in the Intensive Care Unit.I am 18 years old or older.My breathing failure is due to worsening of my long-term muscle disease.I have a tracheostomy tube or will get one within the next week.I am legally allowed to make decisions for the patient.I do not have a family member to make decisions for me.
Research Study Groups:
This trial has the following groups:- Group 1: Family Members of patients in the ICU
- Group 2: ICU Physicians
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the main aim of this research endeavor?
"This clinical trial has a primary goal of gauging the efficacy of the intervention, which will be measured within 96 hours post-consent. Secondary objectives include quantifying decisional regret among families using the Decision Regret Scale (range 5 - 25), measuring psychological distress in families through Impact of Events Revised scale (0-88) and assessing moral stress experienced by physicians via Moral Distress Scale (0-84)."
Answered by AI
Are participants being accepted for this clinical investigation presently?
"Clinicaltrials.gov states that this experiment is not currently recruiting participants, despite being first listed on August 1st 2023 and having its details most recently updated on January 24th of the same year. Fortunately, there are other active studies available at present which may be suitable for interested parties."
Answered by AI
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