Providing Patient Information and CT Examination Results (INFOCT)

Haukeland University Hospital

Status: Completed

Conditions: Chest Pain; Nonmalignant Condition

Treatments: Other: Extended information

Study type: Interventional

Funder types: Other

Identifiers

NCT03781661

2016/1380

Details and patient eligibility

About

Chest pain is a common cause of visits in the Emergency Room and General Practice, and is most commonly connected as a symptom of coronary disease, as for instance angina pectoris and acute myocardial infarct. Approximately 75-80% of these patients are not diagnosed with coronary disease or other cardiac findings. However, many of these patients still report chest pain and worries about cardiac disease.

This study is based on patients that are referred to a CT-examination of the coronary arteries on the background of chest pain, where the CT-examination shows normal coronary arteries.

The study aims to evaluate whether providing an intervention to this group of patients has an effect on patient satisfaction, patient's worry of cardiac disease and incidence of chest pain.

The intervention group will be compared with a similar group going through the same CT-examination, but is receiving the examination result from their regular general practitioner (RGP), which is considered standard care.

The hypothesis is that patients with chest pain with no coronary findings receiving extended information before getting the normal examination results experience a better patient satisfaction than those receiving the examination result from their RGP.

Full description

This study is a randomized controlled study. Eligible patients going through a CT-examination of the heart's coronary arteries, Coronary CT Angiogram (CCTA) will after an informed consent be randomized into two groups, either the intervention group or standard care.

The intervention consists of extended information regarding the benefits of doing a CCTA, thereby emphasising the specificity and accuracy of the CCTA's ability to exclude coronary disease. After this, there will be given an opportunity of a visual go-through and explanation of CT-images. Then they will be informed of the examination result that shows normal coronary arteries.

Follow up is planned after one month, six months and twelve months, where the participants receive the same questionnaire as at baseline to fill out and return. The questionnaire consists of Seattle Angina Questionnaire and RAND-12, in addition to social demographic and clinical data, such as sex, height, weight and current medication.

Enrollment: 92 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ability to speak and read Norwegian fluently
• competent to give informed consent
• referred from cardiologist
• experienced chest pain
• Calcium score = 0 and CCTA must show normal coronary arteries
• received information letter on ongoing research in the Heart department of Haukeland University Hospital

Exclusion criteria

• admitted patients
• heart disease or coronary anomalies shown on the CCTA

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Intervention Group

Experimental group

Description:

The participants in the intervention group will be provided with extended information of the advantages of the CT examination of the heart's arteries. This will be given to the participants both orally and written in form of a leaflet. In addition will they be given the opportunity for a visual go-through of their own calcium score images. After this they will be informed of the normal examination result.

Treatment:

Other: Extended information

Control group

No Intervention group

Description:

Control Group receives standard care.