Using Media to Reduce Anxiety for Cardiac Computed Tomography

Anxiety Clinical Trial

Official title:

Using Media to Reduce Anxiety for Cardiac Computed Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156973
• Other study ID #: 14/P/059
• Secondary ID: 14/WA/0176
• Status: Completed
• Phase: N/A
• First received: May 30, 2014
• Last updated: October 29, 2015
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: October 2015
• Source: Plymouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

Coming for a cardiac test can be a daunting experience. Despite providing written information sheets for patients, experience in the scanner demonstrates that many patients are ill-prepared when they attend for cardiac computed tomography (CT). Heart rate control is essential for high image quality, as this prolongs cardiac diastole (during which imaging occurs) and results in less motion blur, but this may be challenging to achieve in the context of an anxious patient. In such situations, additional radiation exposure is required to optimise the chances of diagnostic images. Thus, poor patient selection and preparation has been shown to increase the radiation burden to the patient, as well as to increase the rate of non-diagnostic scans, leading to patients needing additional, alternative testing. This can be distressing for patients and increases downstream costs for the hospital. Poor patient awareness is also known to increase the anxiety of attending for a test.

Improved patient information and understanding has been shown to improve outcomes in a wide variety of hospital settings. Evidence from cardiac catheterisation angiography suggests that the use of alternative information formats can reduce patient anxiety and improve patient satisfaction, as well as improving their understanding of the technical requirements of a test. The latter may contribute to improved preparation - for example, patients who do not understand the requirements for cardiac CT, particularly the need for a slow heart rate, will often consume caffeine, stop their heart-slowing drugs, or even run or cycle to their appointment.

We have agreed a collaboration with Plymouth University to create patient information videos for CT. These will utilise the expertise of media students (their department also runs a commercial arm, due to the quality of their output), in conjunction with the clinical requirements and patient participation groups, to create an accessible, engaging and informative film. We wish to evaluate the impact of this method of conveying information to patients on how well they are prepared to undergo testing.

If this concept is successful, it may be of use to patients undergoing a huge range of tests or treatments across specialities. We therefore need to demonstrate the efficacy (or otherwise) of such an intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients over 18 years attending for CT coronary angiography during the trial period will be eligible for inclusion

Exclusion Criteria:

• Unable to provide valid, informed, written consent for any reason

• Attending for non-coronary cardiac CT

• Hospital inpatients

• Patients who have previously undergone cardiac CT

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Video information
A six minute information film to address the common themes raised by patients. This will clearly show the scanner, discuss the use of beta-blockers and radiation, and explain the likely side effects of x-ray dye (which can be alarming if patients are not expecting them). In this way we hope patients will be better prepared for the scan.

Locations

Country	Name	City	State
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
Plymouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported level of anxiety in patients attending for CT coronary angiography.	Speilberger State-Trait Anxiety Index has been abbreviated and validated for use in outpatient settings to gauge levels of pre-procedural anxiety and will be completed by patients on arrival in the department and just before their scan.	4 weeks	No
Secondary	The impact of a patient information film on the pre-scan heart rate.		4 weeks	No
Secondary	Patient experience of scan	Ten patients, selected at random from the study population, will be contacted by telephone two weeks later and a semi-structured interview will be undertaken. Patients will be questioned about how informed they felt prior to the scan, whether the scan aligned with their preconceptions, and asked to rate their overall experience.	2 weeks post scan	No
Secondary	The impact of a patient information film on the amount of use of intravenous beta blockers.		4 weeks	No
Secondary	The impact of a patient information film on the diagnostic image quality.		4 weeks	No