Developing a Brief Intervention to Communicate Cardiovascular Risk to Patients Presenting to the Emergency Department With Chest Pain: a Co-Production Approach. Phase 2.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Edinburgh
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Cardiovascular Health
Study Overview
Brief Summary
Some patients who come to the emergency department with chest pain and have not had a heart attack, are at an increased risk of having a heart attack in the future. The investigators know this by taking a blood test (troponin) which looks at damage to the patient's heart.
These patients are often sent home from hospital with no information about their risk of heart disease. A patient survey revealed that patients in the emergency department would like to receive more information about heart disease.
In this study the investigators will provide patients who are at increased risk of cardiovascular disease with their troponin value. The investigators will deliver this information within a cardiovascular brief intervention, which is a short conversation with a patient about their health. In a previous study the investigators carried out some interviews with patients to find out how their results should be delivered and what information should be included in a cardiovascular brief intervention. The investigators also asked them the best way to provide patients with this information. The aim of this part of the study it to determine if the new cardiovascular brief intervention helps patients understand their risk and if it results in them making changes to their health.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who present to the Emergency Department with symptoms suggestive of acute coronary syndrome
- •A maximum high-sensitivity cardiac troponin I between 5 ng/L and the sex-specific 99th centile.
- •Resides in Scotland and has a CHI number
- •Adults aged 18 and over
- •No history of cardiovascular disease
- •At least 1 modifiable cardiovascular risk factor: current smoker, hypertension (140/90 mmHg), hypercholesterolaemia (>6.0 mmol/L), overweight and obesity (BMI >25), hyperglycaemia or diabetes mellitus.
- •Patients who are able to provide informed consent
Exclusion Criteria
- •Patients with a diagnosis of acute coronary syndrome during index presentation
- •Patients who are not able to give informed consent
- •Patients who do not speak English
- •Patients who are unable to attend hospital as outpatient to receive the cardiovascular brief intervention
- •Patients with ongoing or planned cardiovascular investigations or interventions
- •Patients with chronic kidney disease and a eGFR below 30 ml/min
Arms & Interventions
Standard care
Patients assigned to usual clinical care
Intervention
Patients will return to outpatients department to receive a cardiovascular brief intervention
Intervention: Co-designed cardiovascular brief intervention (Behavioral)
Outcomes
Primary Outcomes
Cardiovascular Health
Time Frame: 90 days
Cardiovascular health will be measured using a lifestyle questionnaire based on the American Heart Association's Life's Essential 8 measure of cardiovascular health (Lloyd-Jones, 2022). The components of Life's Essential 8 include (diet, physical activity, nicotine exposure, body mass index, sleep, blood pressure, blood glucose and blood cholesterol). Each component has a scoring metric of 0-100 (table 1) with a composite score of cardiovascular health being the average of all 8 components. A higher score represents better cardiovascular health.
Cardiovascular Health
Time Frame: 90 days
Cardiovascular health will be measured using a lifestyle questionnaire based on the American Heart Association's Life's Essential 8 measure of cardiovascular health (Lloyd-Jones, 2022). The components of Life's Essential 8 include (diet, physical activity, nicotine exposure, body mass index, sleep, blood pressure, blood glucose and blood cholesterol). Each component has a scoring metric of 0-100 (table 1) with a composite score of cardiovascular health being the average of all 8 components. A higher score represents better cardiovascular health.
Secondary Outcomes
- The difference in scores within each component of the Life's Essential 8 cardiovascular health score(90 days)
- High sensitivity cardiac troponin concentrations(90 days)
- Motivational readiness to make changes to improve their cardiovascular health(90 days)