Creation of a Decision Aid for Coronary Anomalies

Официальное название

Development of a Shared Decision Aid for Anomalous Aortic Origin of a Coronary Artery

Обзор

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.

Подробное описание

Anomalous aortic origin of the right coronary artery from the left sinus of Valsalva (R-AAOCA) occurs in \~0.3% of the population. Although R-AAOCA carries an increased relative risk of sudden cardiac arrest (SCA), the absolute risk of SCA is exceedingly low (\~0.02% per year). Both the inability to predict who will experience SCA, and the unknown risks of cardiac surgical intervention to correct this anomaly magnify patients', families', and caregivers' anxiety in deciding on an optimal treatment strategy. Decision aids that foster shared decision-making (SDM) are valuable for helping patients decide on a treatment when no optimal option exists. SDM is a collaborative model of decision making in which patients, families, and providers partake in making joint healthcare decisions. SDM aims to promote clinician and patient/family communication by providing the best available evidence and defining the best treatment strategy for a particular patient based on their values, preferences, and risk tolerance level. Given the complexities and uncertainties in management of patients with asymptomatic R-AAOCA, the use of a decision aid may facilitate SDM and improve psychosocial outcomes. This study aims to develop and test a decision aid to foster SDM for R-AAOCA. The specific aims are to:

Aim 1: Identify the key factors affecting management decision-making for patients with R-AAOCA without evidence of myocardial ischemia, parents/caregivers, and clinicians through a qualitative needs assessment.

Aim 2: Develop a decision aid to foster SDM in determining management strategy in individuals with R-AAOCA without evidence of myocardial ischemia utilizing user co-design principles and iterative feedback from patients, parents/caregivers, and clinicians.

Aim 3: Evaluate the impact of the implementation of the decision aid on SDM, communication, decisional conflict, decisional regret, and quality of life at the time of the decision and longitudinally over the following 6 months in a pre-post implementation study design.

The proposal will result in a patient- and family-centered decision aid to support SDM in R-AAOCA without evidence of myocardial ischemia as well as pilot implementation results to guide a larger study of the aid's use and impact. The pilot data will also allow for insights into the decision making choices of families, as well as the impact the diagnosis of R-AAOCA has on individuals and families. Importantly, this project can serve

Вмешательства

• Другое Decision aid
  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.

Первичные конечные точки

• Shared Decision Making Questionnaire [Срок оценки: Baseline, 3 months, 6 months]

Вторичные конечные точки (5)

• Satisfaction with Decision Scale [Срок оценки: Baseline, 3 months, 6 months]
• Decisional Conflict Scale [Срок оценки: Baseline, 3 months, 6 months]
• Decisional Regret Scale [Срок оценки: Baseline, 3 months, 6 months]
• Patient Satisfaction Questionnaire Short Form [Срок оценки: Baseline, 3 months, 6 months]
• PROMIS-25 [Срок оценки: Baseline, 3 months, 6 months]

Критерии участия

Критерии включения

• Patients

• English-speaking
• 10-35 years of age
• Diagnosis of R-AAOCA without evidence of myocardial ischemia

Parents

• English-speaking
• Child 10-17 years of age
• Diagnosis of R-AAOCA without evidence of myocardial ischemia

Критерии исключения

• Patients

• Other significant cardiac anomalies
• Unwilling or unable to provide consent
• Non-English Speaking Parents
• Child with other significant cardiac anomalies
• Unwilling or unable to provide consent
• Non-English Speaking

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 5 центров

• Boston Children's Hospital — Boston
• Children's Hospital of Philadelphia — Philadelphia
• Vanderbilt University Medical Center — Nashville
• Dell Children's Medical Center — Austin
• Texas Children's Hospital — Houston

Публикации

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Идентификаторы

NCT: NCT07544979 · 260633 · 26CDA1589623

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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