- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02156973
Using Media to Reduce Anxiety for Cardiac Computed Tomography
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.
Aperçu de l'étude
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Devon
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Plymouth, Devon, Royaume-Uni, PL6 8DH
- Plymouth Hospitals Nhs Trust
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Group One Usual care
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.
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Expérimental: Group Two Video information
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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Self-reported level of anxiety in patients attending for CT coronary angiography.
Délai: 4 weeks
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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.
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4 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The impact of a patient information film on the pre-scan heart rate.
Délai: 4 weeks
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4 weeks
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Patient experience of scan
Délai: 2 weeks post scan
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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.
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2 weeks post scan
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The impact of a patient information film on the amount of use of intravenous beta blockers.
Délai: 4 weeks
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4 weeks
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The impact of a patient information film on the diagnostic image quality.
Délai: 4 weeks
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4 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Benjamin Clayton, MBBS, University Hospital Plymouth NHS Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 14/P/059
- 14/WA/0176 (Autre identifiant: National Research Ethics Service)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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