60 Participants NeededMy employer runs this trial

Decision Aid for Anomalous Aortic Origin of a Coronary Artery

Recruiting at 4 trial locations
AM
Overseen ByAndrew M Well, MD, MPH, MSHCT
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to create a decision aid for individuals with right anomalous aortic origin of a coronary artery (R-AAOCA), a condition where the coronary artery originates from the wrong side of the aorta. This tool assists patients, families, and doctors in making informed decisions about managing the condition, which can be stressful due to potential risks. The trial will compare the decision aid with standard care to determine if it improves decision-making comfort and quality of life. It is suitable for English-speaking individuals aged 10-35 diagnosed with R-AAOCA, who do not exhibit signs of restricted blood flow to the heart. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance decision-making for those with R-AAOCA.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this decision aid is safe for use in patients with R-AAOCA?

This trial tests a tool called a decision aid to help manage unusual blood vessel conditions in the heart, known as coronary artery anomalies. Research has shown that decision aids improve patients' understanding of treatment options and support informed choices with their doctors. They are generally safe, as they do not involve medication or surgery.

While specific safety data for this decision aid is not available, it does not involve drugs or surgery, posing no physical risk to participants. Studies on decision aids in other areas have demonstrated their ability to assist in decision-making without causing harm. Participants can therefore feel confident about the safety of using this aid.12345

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for Anomalous Aortic Origin of a Coronary Artery because it offers a personalized approach to understanding coronary anomalies. Unlike the standard of care, which typically involves routine monitoring and generalized advice, this decision aid is designed to provide patients with tailored information, helping them better understand their condition and make informed decisions about their health. The hope is that this tool will empower patients and improve their quality of life by facilitating more effective communication between them and their healthcare providers.

What evidence suggests that this decision aid is effective for improving shared decision making in R-AAOCA?

Research has shown that decision aids in medical settings help patients make informed choices, especially when no single treatment is clearly superior. Studies have found that shared decision-making tools boost patient satisfaction and confidence in their medical decisions. In this trial, participants with right anomalous aortic origin of a coronary artery (R-AAOCA) will be divided into two groups: one receiving standard care and the other receiving standard care with a decision aid. While specific data on decision aids for R-AAOCA is still being gathered, existing evidence suggests these tools improve understanding and comfort in decision-making. Overall, decision aids empower patients to take an active role in their care, potentially enhancing their quality of life.13678

Are You a Good Fit for This Trial?

This trial is for English-speaking patients aged 10-35 diagnosed with right-sided anomalous aortic origin of a coronary artery (R-AAOCA) who do not have signs of reduced blood flow to the heart. Parents of children ages 10-17 with R-AAOCA can also participate if they speak English.

Inclusion Criteria

I am 10-35 years old, speak English, and have R-AAOCA without heart blood flow problems.
I am an English-speaking parent of a 10-17 year old with R-AAOCA and no heart damage.

Exclusion Criteria

Children with other significant cardiac anomalies or unwilling/unable to provide consent
Children with non-English speaking parents
Patients with other significant cardiac anomalies or unwilling/unable to provide consent
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Feedback

Development of a decision aid through user co-design principles and iterative feedback from patients, parents/caregivers, and clinicians

8-12 weeks

Pilot Study

Implementation of the decision aid and evaluation of its impact on shared decision making, communication, decisional conflict, decisional regret, and quality of life

6 months
Baseline, 3 months, 6 months

Follow-up

Participants are monitored for psychosocial outcomes and decision-making impact after the pilot study

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Creation of a Decision Aid for Coronary Anomalies

Trial Overview

The study is testing a new decision aid tool designed to help patients, families, and doctors make informed choices about managing R-AAOCA. The impact of using this tool will be compared to usual care without the aid in a pilot study.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Right AAOCA without evidence of ischemia receiving decision aidExperimental Treatment1 Intervention
Group II: Right AAOCA without evidence of ischemia receiving standard of careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Boston Children's Hospital

Collaborator

Trials
801
Recruited
5,584,000+

Dell Medical School

Collaborator

Children's Hospital of Philadelphia

Collaborator

Trials
749
Recruited
11,400,000+

Baylor College of Medicine

Collaborator

Trials
1,044
Recruited
6,031,000+

Citations

Creation of a Decision Aid for Coronary Anomalies

This proposal will create a decision aid and collect pilot data of its implementation. We hypothesize that the use of an aid in R-AAOCA will ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36846957/

Decision making in anomalous aortic origin of a coronary ...

A multi-disciplinary team with a focus on shared decision-making with the patients/families is likely necessary to optimize outcomes. Long-term ...

Decision analysis to define the optimal management of ...

The goal of this study was to use decision analysis to evaluate the impact of varying uncertainties on the outcomes of patients with anomalous aortic origin of ...

Anomalous Aortic Origin of a Coronary Artery

The aim of this expert review is to collate and critically review the most recent data for an updated perspective by experts in the field. For the purposes of.

Decision analysis to define the optimal management ...

The goal of this study was to use decision analysis to evaluate the impact of varying uncertainties on the outcomes of patients with anomalous aortic origin of ...

Outcomes in Anomalous Aortic Origin of a Coronary Artery ...

In this prospective cohort of patients with anomalous aortic origin of a CA, most have remained free of exercise restrictions.

What is anomalous aortic origin of a coronary artery ...

What is anomalous aortic origin of a coronary artery (AAOCA)? Types of AAOCA, Management of AAOCA, Living with AAOCA.

Expert consensus guidelines: Anomalous aortic origin of a ...

Anomalous aortic origin of a coronary artery is associated with sudden cardiac death. Although the risk for any single affected individual is small.