Creation of a Decision Aid for Coronary Anomalies

Conditions

• AAOCA

Eligibility Criteria

Sex

ALL

Age

10 Years - 35 Years

Healthy Volunteers

Not accepted

Interventions

• Decision aid — OTHER
  The decision aid will be developed as part of this study. It will consist of a patient- and family-centered design and include information desired to support shared decision-making.

Study Details

The coronary arteries supply blood to the heart muscle. Typically, the left coronary artery comes from the left side of the aorta and the right coronary artery comes from the right side. In some cases the coronary artery comes from the wrong side of the aorta. This is known as anomalous aortic origin of a coronary artery (AAOCA). In AAOCA, the major concern is the risk of sudden cardiac death (SCD). The risk of is significantly higher in left AAOCA (L-AAOCA) compared to right AAOCA (R-AAOCA). With the increased risk in L-AAOCA, surgery is recommended to "normalize" the coronary artery position. R-AAOCA has a low absolute risk of SCD. But the risk is higher than the general population. Patients, families, and clinicians must weigh the risks of surgery with the risks of observation. This leads to stress and anxiety around making the management choice. There is no "right" management choice. Shared decision making (SDM) is a strategy of including patient values, preferences, and risk tolerance in medical choices. SDM is particularly useful in settings where there is no clear correct management choice. Decision aids support SDM. No decision aid exists in R-AAOCA. 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 improve SDM, comfort in the choice, and quality of life. We will engage patients, families, and clinicians to understand their needs to make management choices. This will inform the development of the aid. We will gather feedback on the aid from stakeholders and will revise it. The aid will include data and methods for patients to identify their preferences. When the aid is optimized, we will run a pilot study to evaluate its impact compared to not using the aid. We will evaluate SDM, comfort in the choice made, and quality of life at that time, at 3 months and at 6 months. The pilot data will be used to inform a larger study of the aid. This proposal can be an example how to design decision aids for other congenital heart conditions. This aligns with the AHA's mission of improving lifelong health of the whole person. By improving SDM , patients can feel more confident in their choice and relieve anxiety from the diagnosis. Overall, this proposal supports a shift to patient-centered care with a focus on improving meaningful lifelong outcomes.

Key Dates

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Mar 30, 2029

Completion

Mar 30, 2029

Study Design

Enrollment

60 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• No Intervention: Right AAOCA without evidence of ischemia receiving standard of care
  This arm will receive standard of care.
• Experimental: Right AAOCA without evidence of ischemia receiving decision aid
  This arm will receive standard of care along with the decision aid

Primary Outcome Measure

Shared Decision Making Questionnaire [ Time Frame: Baseline, 3 months, 6 months ]

Central Contacts

• Andrew M Well, MD, MPH, MSHCT
  615-343-0042
  [email protected]

Locations (5)

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