Providing Patient Information and CT Examination Results

NCT03781661 | Completed

• 1 other identifier: 2016/1380
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction: Seattle Angina Questionnaire

  Our primary outcome is to examine whether patients with chest pain with normal coronary arteries experience greater satisfaction with their treatment if they receive extended information and the examination results immediately after the CT examination than those who receive the examination result from their RGP. This is measured with 2 single items in Seattle Angina Questionnaire regarding satisfaction with treatment. Values range from 1-5, 1 is the lowest level of satisfaction, and 5 is the highest level of satisfaction. Greater satisfaction with treatment will be defined by a higher score at follow-up after 1 month. In addition, there is a separate question of patients' trust in the CT examination measured with a VAS-scale , ranging from 1-10, 1 represents lowest possible degree of trust, and 10 represents highest possible degree of trust. Greater trust in the CT-examination is defined by higher scores at follow-up after 1 month.

  1 month

Secondary Outcomes (3)

• Worry of having heart disease

  1 month, 6 months, 12 months

• Incidence of chest pain

  1 month, 6 months, 12 months

• Patient satisfaction: Seattle Angina Questionnaire

  6 months, 12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Extended information

Control group

NO INTERVENTION

Control Group receives standard care.

Interventions

Extended information OTHER

The extended information consists out of an information leaflet and a visual go-through of the participants calcium score images. The patients are then given the normal examination result.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (1)

• 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.

  PMID: 34601588 DERIVED

MeSH Terms

Conditions

Chest Pain; Precancerous Conditions; Patient Satisfaction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Tone M Norekvaal, Professor

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental randomized controlled trial

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: June 11, 2018
• Primary Completion: March 4, 2019
• Study Completion: March 4, 2020
• Last Updated: October 14, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)