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Using Media to Reduce Anxiety for Cardiac Computed Tomography

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Video information
Sponsored by
University Hospital Plymouth NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring cardiac computed tomography, Image quality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Plymouth Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group One Usual care

Group Two Video information

Arm Description

Patients attending for CT coronary angiography all receive an information leaflet with their appointment letter, and a brief verbal description of the scan by the radiographer immediately before it is undertaken, as standard care. All patients attending will be offered the opportunity to complete a short questionnaire (until all patients are recruited - anticipated to be 4 weeks). The Speilberger State-Trait Anxiety Index has been abbreviated and validated for use in outpatient settings to gauge levels of pre-procedural anxiety. This will be undertaken on arrival and repeated immediately before the scan, to see if patients feel better prepared after the standard interaction with staff.

The patient video will be introduced to Group Two once Group One has been completed. In addition to the information sheet these patients (again, for four weeks or until recruitment is complete) will be sent an internet hyperlink to its presence on YouTube (video-sharing website) and the Hospital website with their appointment letter. Patients who do not have internet access will be offered the opportunity to see the video in the preparation room while waiting for their scan. Questionnaires will be administered as before, again done twice to examine any late impact of the information on patient anxiety, and the patient will undergo their test.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The impact of a patient information film on the pre-scan heart rate.
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.
The impact of a patient information film on the amount of use of intravenous beta blockers.
The impact of a patient information film on the diagnostic image quality.

Full Information

First Posted
May 30, 2014
Last Updated
October 29, 2015
Sponsor
University Hospital Plymouth NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02156973
Brief Title
Using Media to Reduce Anxiety for Cardiac Computed Tomography
Official Title
Using Media to Reduce Anxiety for Cardiac Computed Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Plymouth NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
cardiac computed tomography, Image quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group One Usual care
Arm Type
No Intervention
Arm Description
Patients attending for CT coronary angiography all receive an information leaflet with their appointment letter, and a brief verbal description of the scan by the radiographer immediately before it is undertaken, as standard care. All patients attending will be offered the opportunity to complete a short questionnaire (until all patients are recruited - anticipated to be 4 weeks). The Speilberger State-Trait Anxiety Index has been abbreviated and validated for use in outpatient settings to gauge levels of pre-procedural anxiety. This will be undertaken on arrival and repeated immediately before the scan, to see if patients feel better prepared after the standard interaction with staff.
Arm Title
Group Two Video information
Arm Type
Experimental
Arm Description
The patient video will be introduced to Group Two once Group One has been completed. In addition to the information sheet these patients (again, for four weeks or until recruitment is complete) will be sent an internet hyperlink to its presence on YouTube (video-sharing website) and the Hospital website with their appointment letter. Patients who do not have internet access will be offered the opportunity to see the video in the preparation room while waiting for their scan. Questionnaires will be administered as before, again done twice to examine any late impact of the information on patient anxiety, and the patient will undergo their test.
Intervention Type
Other
Intervention Name(s)
Video information
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported level of anxiety in patients attending for CT coronary angiography.
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The impact of a patient information film on the pre-scan heart rate.
Time Frame
4 weeks
Title
Patient experience of scan
Description
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.
Time Frame
2 weeks post scan
Title
The impact of a patient information film on the amount of use of intravenous beta blockers.
Time Frame
4 weeks
Title
The impact of a patient information film on the diagnostic image quality.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Clayton, MBBS
Organizational Affiliation
University Hospital Plymouth NHS Trust
Official's Role
Study Director
Facility Information:
Facility Name
Plymouth Hospitals NHS Trust
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

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Using Media to Reduce Anxiety for Cardiac Computed Tomography

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