ISCOMAT

ISCOMAT is a multidisciplinary research collaboration between University of Bradford and University of Leeds involving academics, patients, the NHS and the NIHR Clinical Research Network.

ISCOMAT is a NIHR Programme Grant for Applied Research (PGfAR) funded programme. It began in March 2016 and is scheduled to complete in 2022.

The objective of the programme is to look at and improve how patients with heart failure are supported with their medicines at points of NHS care transition (e.g. from hospital to home). Problems with medicines are common during such transitions, e.g. changes in medicines are not always followed through and doses are not always optimised adequately, both of which can lead to further health events. Patients with heart failure have been chosen for the programme as they are both an NHS priority and are particularly susceptible to medicine management problems, for a number of reasons including that they typically take multiple medicines.

The programme is composed of four interlinked Work Packages:

  • Work Package 1 (WP1) focuses on mapping the current medicines management pathways and establishing underlying data linkage and data collection processes, working with different data providers and using a sample of consenting patients, in order to measure the effect of an intervention as delivered in subsequent Work Packages. Data providers involved include NICOR, NHS Digital, and Primary Care and Pharmacy dispensing systems WP1 is coordinated by CTRU and University of Bradford.
  • Work Package 2 (WP2) has utilised an Experienced Based Co-Design (EBCD) approach to work with patients and healthcare staff to develop the Medicines at Transitions Intervention (MaTI). MaTI aims to make best use of medicines and reduce harm during care transition by enhancing staff training; patient held information; and engagement of community pharmacists. WP2 is coordinated by University of Bradford.
  • Work Package 3 (WP3) is coordinated by University of Bradford and focuses on testing the intervention (MaTI as developed in WP2), for usability and acceptability; and also to determine the potential of its implementation and supporting data collection for evaluation in a definitive trial (WP4).
  • Work Package 4 (WP4) is a definitive, pragamatic multi-centre cluster randomised controlled trial (cRCT) coordinated by the CTRU and sponsored by University of Bradford. The trial includes an internal pilot and embedded process evaluation and health economics evaluation. 2100 patients will be recruited from NHS Trusts over 12 months (per site). Sites will be randomly allocated (1:1) to Usual Care (UC) plus MaTI (the intervention), or UC only (Control). Patients will be followed up for 12 months post randomisation, via self-report questionnaires. The primary objective is to establish whether the intervention reduces all-cause mortality and heart failure rehospitalisation measured over 12 months from hospital discharge. Supporting data will also be collected via the data linkage pathways identified in WP1.

The ISCOMAT trial opened to recruitment on 01/06/2018 and closed to recruitment 28/07/2020.

The programme ultimately aims to improve patients’ understanding of their medicines and the way medical professionals work together to offer good standards of care to patients; both of which may contribute to improving patient health.

The official ISCOMAT programme website is hosted by the University of Bradford: https://www.bradford.ac.uk/iscomat/

ISCOMAT is funded by the National Institute for Health Research (NIHR RP-PG-0514-20009) and received ethical approval from the Yorkshire and the Humber – Bradford Leeds Research Ethics Committee (REC reference 18/YH/0017).
ISRCTN: 66212970 https://doi.org/10.1186/ISRCTN66212970

Information for participants:

Who is responsible for your data?

The joint data controllers for this trial are the sponsoring organisation, Bradford Teaching Hospitals NHS Foundation Trust (BTHFT) and The University of Leeds (UoL). This means that both organisations are responsible for how your data is used.

What information do we collect about you?

Staff within the NHS collect information from you and your medical records for this research and send it to the Clinical Trials Research Unit (CTRU) at the University of Leeds. The CTRU will use your name, address, and contact details to contact you about the research study, namely for the purpose of sending questionnaires and providing any study updates.

Your NHS number, gender, initials, date of birth and postcode will be shared with NHS Digital and other central NHS registries, including the National Heart Failure Audit (NHFA) (via National Institute for Cardiovascular Research (NICOR)), to obtain information about you from your electronic health care records. We will do this because it is a more efficient way to collect certain data about your health. By using data collected from routine health visits, we can reduce the burden (such as the number of hospital visits) on you and your hospital. When we do this linking, we will only use the data mentioned above to identify you, and we will follow strict rules when working with other organisations to maintain confidentiality and to protect your data. You can read more about NHS Digital here: https://digital.nhs.uk/about-nhs-digital.
The information received from NHS Digital and other registries will be imported into a database held securely at the Clinical Trials Research Unit.
Individuals from the BTHFT (the study sponsor) and regulatory organisations may look at your medical and research records to make sure the study has been run correctly. The only people at BTHFT and UoL who will have access to information that identifies you are the people involved in study follow-up (e.g. posting questionnaires) or auditing the data. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

How long we keep your data

Bradford Teaching Hospitals NHS Foundation Trust and the University of Leeds will keep your data for a minimum period of 10 years after the end of the study, after which it will be securely destroyed.

How we protect your data

We protect your personal data against unauthorised access, unlawful use, accidental loss, corruption or destruction.
We use technical measures such as encryption and password protection to protect your data and the systems they are held in. We also use operational measures to protect the data, for example by limiting the number of people who have access to the databases in which your data is held and using unique reference numbers to identify participants rather than names wherever possible.
We keep these security measures under review and refer to Bradford Teaching Hospitals NHS Foundation Trust and the University of Leeds Information Security Policies to keep up to date with current best practice.

Sharing your data

Your personal data which are collected and managed by the University of Leeds will be used to carry out the follow-up of this trial, including linking your personal data with data held by NHS Digital and the NICOR National Heart Failure Audit. In order to do this, we will provide your initials, gender, date of birth, NHS number and postcode to NHS Digital and the National Heart Failure Audit. The information we have about you will be linked with the information held by these data providers. This will be done in a secure and confidential manner.
It is possible that the information collected about you might be shared with other research teams to answer new research questions in the future. If this happened, the information would be anonymised so that no-one would be able to identify you from it.
Your rights
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.
You can find out more about how we use your information:
https://www.hra.nhs.uk/information-about-patients/
https://www.bradfordhospitals.nhs.uk/privacy-statement/
https://ctru.leeds.ac.uk/privacy/

Our Ethical approval and legal basis to process your data

ISCOMAT is funded by the National Institute for Health Research (NIHR RP-PG-0514-20009) and received ethical approval from the Yorkshire and the Humber – Bradford Leeds Research Ethics Committee (REC reference 18/YH/0017).
Organisations processing personal data need a legal basis for that processing activity. For public authorities, such as the NHS and Universities, the most appropriate lawful bases when processing personal data and health data (defined as special category data) for the purposes of research are:
Article 6:1(e): Specific task in the ‘public interest’ or task that has a clear basis in law, and
Article 9:2(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”, with a basis in law.
To ensure we carry out the research to the highest standards we comply with the UK Policy Framework for Health and Social Care Research. You can learn more about research standards here: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/

Complaints

If you wish to raise a complaint on how we have handled your personal data, you can contact the Data Protection Officer who will investigate the matter.
University of Leeds Data Protection Officer
• Phone +44 (0) 113 2431751
• Email: dpo@leeds.ac.uk
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) by visiting https://ico.org.uk/make-a-complaint/ or by calling their helpline on 0303 123 1113.

Contact us

If you would like to contact us directly for more information about how we process and protect data collected for research, please email: iscomat@leeds.ac.uk

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