Adverse Childhood Experiences in Patients With Coronary Artery Disease Pilot

Study Overview
=================
Brief Summary
-----------------
Adverse Childhood Experiences (ACEs) are potentially harmful events occurring during childhood that have been associated with chronic physical conditions in adulthood, including coronary artery disease (CAD). ACEs may constitute a portion of the remaining unexplained residual risk for CAD in adults. Identifying a means of addressing these experiences may mitigate their health consequences and result in improved cardiovascular outcomes. The primary objective of this study is to determine if patients who undergo ACE screening experience improved quality of life compared to patients who undergo conventional lifestyle assessment. This will be a single-centre, pragmatic, single-blinded (i.e. data analysts), 1:1, pilot randomized control trial.

Detailed Description
-----------------
ACEs encapsulate a broad spectrum of traumatic and distressing events occurring before the age of 18 that span the domains of abuse, household dysfunction, neglect, amongst others, and that threaten a child's physical, familial or social safety. The landmark ACE Study, published by Felitti and colleagues, was the first study to propose the association between ACEs and the development of chronic physical conditions in adulthood, including cardiovascular disease (CVD). Due to a variety of mechanisms, exposure to an ACE increases predisposition to the development of CVD and its conventional risk factors. ACEs nonetheless remain underrecognized and undermanaged in routine cardiovascular clinical encounters. Integration of ACE screening into the standardized clinical assessment of CVD may enable cardiologists to better identify patients who might benefit from further post-ACE resiliency interventions and serve as an impactful secondary and tertiary prevention strategy. The ACE screening process itself may be therapeutic as it gives patients the opportunity to discuss their early experiences, reflect on the role of early adversity in their current health problems, and have some sympathetic acknowledgement about this history from a health care professional. This has been termed ACE insight. Screening for ACEs has been found to be acceptable by patients. Patients may have never had any opportunity to discuss ACEs they have undergone throughout their entire life, enabling their effects to propagate into adulthood. Inquiring about ACE exposure during clinical encounters with all patients may garner insights that can have a beneficial effect in improving cardiovascular health. Additionally, engaging patients in stress-coping therapies, such as mindfulness, and referral for psychological consultation as needed, may also be helpful. Although logical, these strategies still lack adequate evidence and a randomized trial is needed to evaluate their potential in reducing the occurrence of cardiovascular events. This study aims to assess whether deleterious childhood exposures are associated with an increased prevalence of risk factors for CAD and represent an independent risk factor for CAD. Furthermore, screening for ACEs in patients with CAD may serve as a therapeutic intervention in itself by providing both ACE insight and a platform to unload internal psychological burdens. Screening may result in an enhanced quality of life, as well as improved health behaviours that may benefit their cardiovascular outcomes.

Official Title
-----------------
Adverse Childhood Experiences in Patients With Coronary Artery Disease: a Pilot Randomized Control Trial

Conditions
-----------------
Adverse Childhood Experiences, Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Philadelphia ACE Survey
* Other: Lifestyle Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years at screening History of (1) acute coronary syndrome (ACS) OR (2) coronary artery disease (CAD) necessitating prior cardiovascular intervention. History of ACS determined by documentation of ST-elevation myocardial infarction or non-ST-segment elevation infarction 1-12 months prior to time of screening. History of CAD determined by documentation of percutaneous coronary intervention or coronary artery bypass surgery within the last 1-12 months. Able to complete a survey independently Access to a phone Willingness to participate as evidenced by signing of the study informed consent form Exclusion Criteria: Inability to speak, read and write in English Cognitive impairment Severe physical or mental illness Limited life expectancy (projected to be less than 1 year)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACE Screen<br>At the initial visit, the Philadelphia ACE Survey, a validated ACE questionnaire, will be administered by a research coordinator. A Lifestyle Assessment package will also be provided for self-completion, featuring General Demographics, Cardiovascular and Medication History, Health Behaviours, the Short Form (36) Health Survey, the Patient Health Questionnaire-9, the General Anxiety Disorder-7 questionnaire, the Seattle Angina Questionnaire-7, and the modified Perceived Need for Card Questionnaire. Patients who test positive for ACE will receive a 3-page printed ACE Resource Pack. At 3 months, the Lifestyle Assessment will be administered again. At 6 months, the Philadelphia ACE survey, Lifestyle Assessment, as well as a scale assessing their comfort level in being screened for ACE, disclosing their ACE status to their clinicians, and their confidence level in their clinicians' ability to help them manage their ACEs will be administered. | Other: Philadelphia ACE Survey<br>* The Philadelphia ACE survey assesses the three major domains featured within the original ACE Study Questionnaire developed by Felitti et al. (abuse, neglect, and family dysfunction), in addition to five community-level stressors.<br>Other: Lifestyle Assessment<br>* The Lifestyle Assessment questionnaire features the Short Form (36) Health Survey, Patient Health Questionnaire-9, General Anxiety Disorder-7 questionnaire, Seattle Angina Questionnaire-7, and modified Perceived Need for Card Questionnaire, which are validated questionnaires for the assessment of quality of life, depression, anxiety, angina, and perceived need for care, respectively.<br>|
| Other: Lifestyle Assessment<br>At the initial visit, no Philadelphia ACE Survey will be administered. The Lifestyle Assessment packaged will be provided for self-completion, featuring General Demographics, Cardiovascular and Medication History, Health Behaviours, the Short Form (36) Health Survey, the Patient Health Questionnaire-9, the General Anxiety Disorder-7 questionnaire, the Seattle Angina Questionnaire-7, and the modified Perceived Need for Card Questionnaire. At 3 months, the Lifestyle Assessment will be administered again. At 6 months, the Philadelphia ACE survey, Lifestyle Assessment, as well as a scale assessing their comfort level in being screened for ACE, disclosing their ACE status to their clinicians, and their confidence level in their clinicians' ability to help them manage their ACEs will be administered. | Other: Lifestyle Assessment<br>* The Lifestyle Assessment questionnaire features the Short Form (36) Health Survey, Patient Health Questionnaire-9, General Anxiety Disorder-7 questionnaire, Seattle Angina Questionnaire-7, and modified Perceived Need for Card Questionnaire, which are validated questionnaires for the assessment of quality of life, depression, anxiety, angina, and perceived need for care, respectively.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported quality of life | Degree of change in quality of life measured by the Short Form (36) Health Survey questionnaire | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Rate of all-cause mortality | 6 months | 
| Cardiovascular hospitalization | Rate of hospitalization for ACS, heart failure, stroke and atrial fibrillation | 6 months | 
| Myocardial infarction | Rate of myocardial infarction | 6 months | 
| Stroke | Rate of stroke | 6 months | 
| Need for urgent repeat coronary revascularization | Rate of need for urgent repeat coronary revascularization | 6 months |