Clinical trial NCT03781661: Providing Patient Information and CT Examination Results
Official title: Providing Patients With Extended Information and Examination Results Immediately After a Diagnostic CT of the Coronary Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Nonmalignant Condition
Keywords: Non coronary Chest Pain
Extended Information
Normal Examination Result
Coronar Computed Tomography Angiography
CCTA
Calcium score
Diagnostic Examination
Patient Satisfaction
Normal Coronary Arteries
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction: Seattle Angina Questionnaire
timeFrame: 1 month
Secondary outcomes:
measure: Worry of having heart disease
timeFrame: 1 month, 6 months, 12 months
measure: Incidence of chest pain
timeFrame: 1 month, 6 months, 12 months
measure: Patient satisfaction: Seattle Angina Questionnaire
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: University of Bergen
name: Tone M Norekvaal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krohn IL, Rygh CB, Larsen TH, Wentzel-Larsen T, Norekval TM. Effect of radiographer-led intervention on reassurance, treatment satisfaction, and recurring chest pain in patients with a normal coronary computed tomography angiography-a randomized controlled trial. Eur J Cardiovasc Nurs. 2022 Jun 2;21(4):318-324. doi: 10.1093/eurjcn/zvab064.