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The University of Southampton
Southampton Clinical Trials Unit

FORECAST

Title

Fractional Flow Reserve Derived from Computed Tomography Coronary Angiography in the Assessment and Management of Stable Chest Pain.

Description

This trial aims to test the hypothesis that FFRCT, used as the default screening tool for patients presenting with recent onset stable chest pain, would be associated with (i) shorter rapid time period between initial consultation and definitive management plan; (ii) better patient experience; (iii) lower overall use of resources.

Objectives

Primary Objective:
To determine whether, in a population of patients presenting to RACPC, routine FFRCT as a default test is superior, in terms of resource utilisation at 9 months, when compared to routine clinical pathway algorithms recommended by NICE CG95.

Secondary Objectives:
1.    To compare clinical outcomes between the two groups at 9 months.

2.    To compare the effect on general wellbeing between the two groups at 9 months.

Trial Design

FORECAST is a randomised controlled trial with a sample size of 1400.

Trial Status

Open to Recruitment.

Population

Adults (aged over 18) with primary symptom of chest pain who are deemed to require a test at initial RACPC assessment and are willing and able to provide written informed consent.
 

How we use your data if involved in the FORECAST trial

As a unit responsible for delivering clinical trials within the University of Southampton we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research.  This means that when you agree to take part in the FORECAST research study, we will use your data in the ways needed to conduct and analyse the research study or trial. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.

What legal basis do we have to process your information?

The FORECAST trial requires ethically approved voluntary explicit written consent to participate. Information given to the participants, family member or carer in the trials or studies is included within the relevant participant information sheets, consent forms, and other project-specific documentation created and supplied by those running the trials. Processing your information for trials is necessary for the performance of a task carried out in the public interest (GDPR Article 6(1)(e)) and under Article 9(2)(j) necessary for archiving purposes in the public interest, scientific or historical research purposes in accordance with Article 89 (1).

How we use your data

Of course, all of the data submitted to us is treated confidentially. Any identifiable information will strictly not be shared with anyone outside the trial team, aside from the Health & Social Care Information Centre (HSCIC). When you kindly consented to being involved in the FORECAST trial, this organisation was called the NHS Information Centre, they have since changed their name to NHS Digital. This enables us to share your NHS number with this organisation and they use it to link to health and mortality datasets that they hold in order to provide us with information about your current health status.

NHS Digital receive data from the Office of National Statistics (ONS), (Note: for patients from Scotland this is collected from the National Records of Scotland), regarding any patients who have sadly died. Our trial team will then be informed, and the cause of that death. Linking with the HSCIC enables us to get information about participants, even if your treating hospital has lost contact with you.

Your participation is voluntary and we very much hope that you will continue to participate in our research and let us use your data. However, you are free to withdraw at any time and without giving a reason. A decision to withdraw at any time will not affect the standard of care you receive.

Rights to withdraw

There are two options if you choose to withdraw:

Your participation is voluntary and we very much hope that you will continue to participate in our research and let us use your data. However, you are free to withdraw at any time and without giving a reason. A decision to withdraw at any time will not affect the standard of care you receive. There are two options if you choose to withdraw:

  • Complete withdrawal: We will attempt no further contact. No further trial visits will be scheduled and no additional data will be collected about you from the point of your withdrawal. Note, it will not be possible to remove data that we have previously collected and processed from our analyses.
  • Partial withdrawal: The information you have given us up to today will be used in our analysis but there will be no more trial visits and only information from your patient notes in hospital will be collected going forward.

For any trial which already has had substantial results and publications, we won’t be able to destroy any data we hold about you up until your withdrawal. However, your data has been de-identified so you can be assured that you will not be personally identified in any reports, presentations or publications. If you would like to obtain a copy of published results, please ask your doctor.

If you wish to withdraw either completely or partially, or have any other enquiries relating to participation, please contact Southampton Clinical Trials Unit on ctu@soton.ac.uk or 023 8120 5154.

Period of retention

We will hold your data for 15 years after the end of trial notification.

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

Southampton CTU have an authorised and up to date NHS digital toolkit ref EE1333879-CTU. For a copy of this toolkit please contact legalservices@soton.ac.uk quoting the toolkit reference number. 

Our Data Protection Officer is a member of legal services and you can contact them at legalservices@soton.ac.uk.

Trial Team:

Senior Trial Manager:

Zina Eminton (023 8120 8214)

Trial Manager:

Darran Ball (023 8120 5556)

Clinical Data Coordinator:

Lucy Hogan (023 8120 5605)

Contact information

Email: forecast@soton.ac.uk

Fax: 0844 7740 621

SAE Reporting: ctu@soton.ac.uk or 0844 7740 621

 

Essential Trial Documents

FORECAST Protocol v3 20-Mar-2019

FORECAST Informed Consent Form v3 6-Jun-2018

FORECAST Patient Information Sheet v3 6-Jun-2018

FORECAST GP Letter v1 17-Aug-2017

FORECAST Patient Flagging Form v1.0 19.12.2017

FORECAST Patient Invitation Letter v1 17-Aug-2017

FORECAST Poster v1 01-AUG-17

Patient Questionnaires

Effective UK (English) EQ-5D-5L Paper Self complete v1.0

Effective UK (English) EQ-5D-5L Paper Telephone v1.2

FORECAST Patient Satisfaction Questionnaire v2 19-Sep-18

SAQ-7

ISF Documents

FORECAST Site Delegation Log v2 25-Jul-2018

FORECAST Template Patient Screening Log v1 13-Nov-2017

FORECAST Master Patient List v2 25-Jul-2018

FORECAST Serious Adverse Event Report Form v1 21-Feb-2018

FORECAST FFRCT Site Training Record v2 25-Jul-2018

FORECAST Site Visit Log v3 16-Nov-2018

FORECAST Site Set-Up Meeting Slides v5 04-Jun-2018

FORECAST Site Initiation Slides 09-Apr-2018

Database-related Documents

FORECAST eCRF Completion Guidance v2 26-Jul-18

FORECAST Baseline Crib Sheet v1 13-Apr-2018

FORECAST Randomised CT - Radiology Crib Sheet v1 24-May-2018

FORECAST Randomised CT - Cardiology Crib Sheet v1 24-May-2018

FORECAST Final Treatment Plan Crib Sheet v1 13-Apr-2018

FORECAST 3 Month Follow up Crib Sheet v2 26-Jul-2018

FORECAST 9 Month Follow up Crib Sheet v2 26-Jul-2018

User Manuals

FFRCT Instructions for use

Newsletters

FORECAST Newsletter Issue 1 - September 2018

FORECAST Newsletter Issue 2 - January 2019

FORECAST Newsletter Issue 3 - March 2019

FORECAST Newsletter Issue 4 - May 2019

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