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 statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Edinburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Co-designed cardiovascular brief intervention

    Behavioral

    Patients will be randomised to a brief intervention where they will be informed of their high-sensitivity cardiac troponin value and cardiovascular risk.

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: Standard careNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cardiovascular Health

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.

Time frame
90 days

Secondary outcomes

1

High sensitivity cardiac troponin concentrations

High-sensitivity cardiac troponin I will be assessed as an absolute value and change between baselines and 90 days for the secondary objective. Additional exploratory analyses will evaluate other high-sensitivity cardiac troponin assays and measures.

Time frame
90 days
2

Motivational readiness to make changes to improve their cardiovascular health

Patient's motivation will be assessed using a "readiness ruler" linear numeric scale (0-10)

Time frame
90 days
3

The difference in scores within each component of the Life's Essential 8 cardiovascular health score

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).

Time frame
90 days

Other outcomes

1

Cardiac medication adherence

Medication use and adherence will be assessed using the Medication Adherence Reporting Scale (MARS-5) (Horne 1999). The participants will rate 5 different adherence behaviours on a five-point scale. The scores are combined to provide a total score, with the higher scores indicating a higher level of reported adherence to medication.

Time frame
90 days
2

Proportion of participants recruited from screening log

Recruitment rates and patients lost to follow up will be assessed from the trial consort diagram which will detail the participants' pathway though the study.

Time frame
90 days
3

The quantity of missing data at baseline and follow up

The proportion of missing data will be assessed from the case report forms.

Time frame
90 days
4

The presence or increase of anxiety and/or depression

Anxiety and depression will be assessed using the Hospital and Anxiety Depression Scale (HADS) (Zigmond and Snaith 1983). The HADS consists of 14 questions which can be scored from 0 to 3. Anxiety and depression are scored separately with a maximum score of 21 for each category.

Time frame
90 days

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