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Providing Patient Information and CT Examination Results (INFOCT)

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ClinicalTrials.gov Identifier: NCT03781661
Recruitment Status : Active, not recruiting
First Posted : December 20, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Tracking Information
First Submitted Date  ICMJE December 18, 2018
First Posted Date  ICMJE December 20, 2018
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE June 11, 2018
Actual Primary Completion Date March 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
Patient satisfaction: Seattle Angina Questionnaire [ Time Frame: 1 month ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
Patient satisfaction: Seattle Angina Questionnaire [ Time Frame: 1 month ]
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 general practitioner. This is measured with Seattle Angina Questionnaire in addition to a separate question of patients' trust in the CT examination.
Change History Complete list of historical versions of study NCT03781661 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
  • Worry of having heart disease [ Time Frame: 1 month, 6 months, 12 months ]
    To examine if patients report less worry of having a heart attack or sudden death after having a CT examination of the heart's arteries, when receiving extended information and the normal examination result immediately after the CT examination. This is measured with a single item in Seattle Angina Questionnaire regarding worry of having heart attack or die suddenly. Values range from 1-5, 1 represents "worry all the time" and 5 represents "never worry". Less worry of having a heart attack or die suddenly will be defined by higher scores at follow-up after 1, 6 and 12 months.
  • Incidence of chest pain [ Time Frame: 1 month, 6 months, 12 months ]
    To examine if patients with chest pain with normal coronary arteries report less chest pain and/or less use of health care services if they receive extended information and the examination results immediately after the CT examination compared to those who receive the examination result from their RGP. This is measured with 2 single items in Seattle Angina Questionnaire. One item regards limitations in everyday activities because of chest pain. Values range from 1-5, 1 represents lowest level, and 5 represents highest level of function. The second item is about incidence of chest pain the last week. Values range from 1-5, 1 represents high incidence of chest pain and 5 represents no chest pain. Less chest pain is associated with higher scores at all times of follow up, compared to baseline. In addition, clinical data regarding participants use of primary and secondary health care the last 4 weeks is collected at all times of follow-up and is compared to baseline data.
  • Patient satisfaction: Seattle Angina Questionnaire [ Time Frame: 6 months, 12 months ]
    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 6 and 12 months.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • Worry of having heart disease [ Time Frame: 1 month, 6 months, 12 months ]
    We want to examine if patients report less worry of having a heart attack and die of heart disease after having a CT examination of the heart's arteries, when receiving extended information and the normal examination result immediately after the CT examination. This is measured with Seattle Angina Questionnaire.
  • Incidence of chest pain [ Time Frame: 1 month, 6 months, 12 months ]
    We want to examine if patients with chest pain with normal coronary arteries report less chest pain and/or less use of health care services if they receive extended information and the examination results immediately after the CT examination than those who receive the examination result from their general practitioner. This is measured with Seattle Angina Questionnaire in addition to clinical data.
  • Patient satisfaction: Seattle Angina Questionnaire [ Time Frame: 6 months, 12 months ]
    We want 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 during follow up after 6 and 12 months, than those who receive the examination result from their general practitioner. This is measured with Seattle Angina Questionnaire in addition to a separate question of patients' trust in the CT examination.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Providing Patient Information and CT Examination Results
Official Title  ICMJE Providing Patients With Extended Information and Examination Results Immediately After a Diagnostic CT of the Coronary Arteries
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Experimental randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Chest Pain
  • Nonmalignant Condition
Intervention  ICMJE Other: Extended information
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.
Study Arms  ICMJE
  • Experimental: Intervention Group
    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.
    Intervention: Other: Extended information
  • No Intervention: Control group
    Control Group receives standard care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 19, 2018)
92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 4, 2020
Actual Primary Completion Date March 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03781661
Other Study ID Numbers  ICMJE 2016/1380
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tone M Norekvaal, Professor University of Bergen
PRS Account Haukeland University Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP