Prospective Triage HF+ Evaluation: What is the workload burden associated with using the Triage HF+ care pathway?

Manchester University NHS Foundation Trust · NHS Trust

In term In term in the September 2026 edition: the latest version runs to 6 May 2029.

Reference: DARS-NIC-401890-W6Q8W
Current version: v3.7
Term of current version: 7 May 2026 to 6 May 2029
Start date: 18 February 2021
Data controller: Sole Data Controller
Commercial purposes: Yes
Sublicensing: No
Files released to date: 49

Why the data was released

Objective for processing

The primary purpose of the TRIAGE study is to establish the workload burden associated with a newly developed clinical pathway called “Triage-HF Plus”. This pathway uses a risk score generated from implanted cardiac devices (Heart Failure Risk Score “HFRS”) to guide a remote monitoring service – where patients identified at ‘high’ risk of decompensated heart failure are telephoned by clinical staff in an attempt to 1) diagnose and treat issues early in the course of illness and 2) reduce risk of hospitalisation. An important part of evaluating this pathway is to establish the burden of implementing the pathway on the provider – an essential part of health economic analysis. Secondary objectives of the TRIAGE study include exploration of the relationship between clinical pathway and events (healthcare utilisation and mortality), specifically:

1) Comparison of frequency and type of clinical touchpoints and patient outcomes pre-Triage-HF Plus (current state) and post-Triage-HF Plus Implementation (future state, prospective).

2) Estimation of cost of Triage-HF Plus care pathway at each site

3) Exploration of relationships between Triage-HF with patient demographics and heart failure events

4) Exploration of relationships between Triage-HF with patient demographics and non-heart failure events such as frailty

The TRIAGE study follows on from the research project entitled ‘Triage-HF Plus: Cardiac Implantable Electronic Device Remote Monitoring Combined with Telephone Triage to Identify and Manage Worsening Heart Failure’, hereafter referred to as ‘Retrospective TRIAGE’. ‘Retrospective TRIAGE’ was a retrospective service evaluation project evaluating the predictive efficacy of the HFRS. This evaluation piece was supported by a Section 251 approval. The TRIAGE study follows on from this piece of work – a prospective study with informed consent from each participant.

For the TRIAGE study, patients were initially being recruited from three hospital sites across North West England, with an initial recruitment target of a single cohort of 450 participants. Enrolment of new patients into the registry is now proposed to end on 30th June 2024, with follow-up (entry of phone call assessment into the eCRF) to end on 30th June 2025. The first patient was recruited in September 2019. Enrolment of new patients into the registry is proposed to end on 30th June 2024, with follow-up (entry of phone call assessment into the eCRF) to end on 30th June 2025. Inclusion criteria identify patients 18 years or older with a compatible Medtronic cardiac device. Patients must be able to provide written, informed consent in the English language.

Data from NHS England is requested to provide pseudonymised record-level information about both healthcare utilisation and mortality for each participant, allowing evaluation of the efficacy of the Triage-HF Plus pathway. Healthcare utilisation data will be provided from the Emergency Care Data Set (ECDS), Hospital Episode Statistics (HES) Admitted Patient Care (APC), HES Accident & Emergency (A&E) and HES Outpatients data. Civil Registration Deaths will provide the required mortality information.

NHS England HES data is required because many participants’ local hospitals will be elsewhere in the region and the local data will not provide the necessary complete set of information. There are no less intrusive ways of achieving this data reliably. It is not feasible to rely on patients to remember dates of hospital attendances. Data requested will be minimised to the 24 months prior to recruitment, and up to 3 years after completion of the evaluation. Clinical data requested has been reviewed by 2 clinical researchers at Manchester University NHS Foundation Trust (MFT - previously known as Central Manchester NHS Foundation Trust), and the University of Manchester data analysis team. This is to ensure that the data is both minimised and sufficient for achieving study outcomes. Data is required to be record-level in order to perform a meaningful analysis.

In order to undertake a thorough analysis of workload burden pre- and post- implementation of the Triage-HF Plus pathway, data are required for all healthcare utilisation touchpoints. Although the pathway is centred on data from cardiac devices, previous research has suggested that a high HFRS may represent non-cardiac illnesses and physiological disturbances from procedures/operations, potentially leading to both useful clinical warnings, and 'false positives' creating extra unnecessary workload. Information relating to any of the clinical classification codes from 'International Statistical Classification of Diseases and Related Health Problems 10th Revision' (ICD-10 - for diagnoses) and 'OPCS Classification of Interventions and Procedures' (OPCS4), as well as all 'Secondary Use Service' codes (hospital payment information for carrying out different services) are therefore requested for the cohort in order to address the study hypotheses.

The TRIAGE study is a stand-alone study. It is not part of a wider project or collaboration. No follow-up work is currently planned. NHS England data collected as part of this application will be used as described above for the TRIAGE study and for inclusion in an affiliated PhD project only. The PhD candidate is a substantive employee of MFT who is completing their thesis as a student of the University of Manchester.

MFT are the sole data controller for this study who also process the data. The University of Manchester is also a data processor. Medtronic Limited are the funder and commercial partner for the study. They provide device data to MFT via the One Hospital Clinical Service platform. Medtronic have no access to record level NHS England data and have no influence over study results or outputs generated. They will have access to aggregated data with small numbers suppressed. Medtronic may benefit from the study if results show that the associated Triage HF Plus clinical pathway reduces NHS workforce burden, and guidelines change to support the uptake of this pathway.

TRIAGE is sponsored by MFT in partnership with Medtronic Limited. Pennine Acute Hospitals NHS Trust and Wythenshawe hospital will provide cohort identifiers to MFT to send to NHS England. These organisations are involved in the clinical evaluation of patients within the overall study but do not have access to NHS England data.

The Article 6 UK GDPR justification for processing is 6(1)(e): ‘processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller’

The collection of data from NHS England is essential for the completion of the TRIAGE study. This is in the public interest as: (1) results from the TRIAGE study will advance academic and clinical knowledge and understanding of workload burden associated with, and efficacy of the Triage-HF Plus care pathway, (2) results from the TRIAGE study will in likelihood lead to either further clinical studies or direct change in clinical service provision with the aim of improving patient care and (3) all participants have expressed willingness of their data to be used as part of the TRIAGE study to advance academic knowledge.

The Article 9 UK GDPR justification for processing is 9(2)(j): ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.’

Data processing is in the public interest for the benefit of health and social care. The study is sponsored and being run in NHS hospital sites, and results will feed directly into NHS clinical improvement projects. Safeguards to protect data subjects are in place as per MFT data security and data protection policies.

Processing activities

The data flows will be as follows:

Information provided to NHS England will be record-level identifiable patient data. Personal data for each study participant will be provided to NHS England by Manchester University NHS Foundation Trust (MFT). Data transfer will occur via an encrypted data transfer service. This data will be Study ID (unique 6-digit number “study participant number/SPN”), the recruitment date for each patient into the trial, and personal identifiers only: NHS Number, Date of Birth, Sex, Postcode.

Linked pseudonymised NHS England health data (Emergency Care Data Set (ECDS), Hospital Episode Statistics (HES) Admitted Patient Care (APC), HES Accident & Emergency (A&E), HES Outpatients data and Civil Registration Deaths will be provided to MFT via an encrypted transfer system. Access to confidential information at MFT is restricted to on-site computers or via remote access. On and off-site, access requires trust usernames and passwords to access the MFT server. NHS England data will be stored within a specified password-protected sub-folder, for which access is limited to a small number of specified authorised personnel on the TRIAGE study team who are substantive employees of MFT and have been appropriately trained in data protection and confidentiality.

The received NHS England data will be checked and cleaned/formatted at MFT. This will occur either on-site or via secure remote access in line with national UK Government guidance during the COVID-19 pandemic to work from home wherever feasible. Off-site remote access is facilitated via VMware Horizon using RSA software tokens. In addition to a unique time-sensitive username and password required to access the remote access portal, this process also requires the same security processes as per on-site access.

After checking and cleaning of the NHS England data, it will be combined with other evaluation data (cardiac device data from Medtronic One Hospital Clinical Service platform and data from case report forms) using each participant’s SPN only to create a complete pseudonymised research database for analysis. It will not be linked with any other databases.

In order to facilitate the movement of data out of MFT to the University of Manchester (UoM), the SPN-coded database will undergo an additional ‘sense check’ to ensure no participant could be identified and all non-essential information for the purpose of analysis is removed. Any data leaving the MFT will be reviewed by the study Chief Investigator to ensure compliance with local guidance, approvals, and legislation. The SPN-coded database will be shared via encrypted transfer service with trusted academic collaborators based in the Centre for Health Informatics at the UoM, who will be appointed to undertake data analysis as explained to study participants in the Patient Information Sheet. The SPN-coded database will be transferred into the UoM Data Safe Haven (DSH) and (on request from MFT), processed data will be transferred back to MFT to facilitate additional analyses. There will be no attempt to re-identify individual participants.

Analysis of the linked de-identified data will assess the workforce burden associated with the pathway by comparing healthcare utilisation (HCU) before and after implementation of the clinical pathway, assess health economics pre and post-implementation, and involve exploration of a number of secondary objectives as previously described. NHS England data regarding (1) accident and emergency attendances (2) admitted care episodes, (3) outpatient attendances and (4) mortality are required to perform a meaningful analysis which will influence provision of care in the future.

The DSH is purpose built for the secure management and processing of personal, special category and confidential information. Access to the DSH is only granted to a limited number of named researchers who are substantive employees of the UoM, have completed the University’s Data Protection Training and are authorised by the Research Governance, Ethics and Integrity team (RGEIT). Each DSH user has a project file within the DSH, which is accessible to that user only. Access to the DSH is restricted to on-campus connectivity only. Only named individuals are authorised to move data in or out of the DSH, under specific authorisation of a named information governance lead of the project. No personnel outside the direct employment of the UoM or MFT will have access to the SPN-coded database containing record level NHS England data.

The SPN-coded database is downloaded into the DSH via a single point - a static IP addressed laptop within the RGEIT office. After logging on to the laptop with their UoM username and password, the named academic analysts will access the DSH using the University’s 2-factor authentication Service (Duo) to verify their identity. SPN-coded data will be transferred into a password-protected sub-folder in the principal investigator’s project folder within the DSH using the Secure Transfer Service. File transfers, copy/paste and print functionality has been disabled within the DSH. Record level data will not leave the DSH/MFT secure servers.

Data analysis will be performed using software within the DSH (mainly Microsoft Excel, SPSS, R, GraphPad) and at MFT. Data will be stored until one year after the final data dissemination, providing enough time to complete all analysis and publish study findings. A valid data sharing agreement will be maintained until all such analysis has been completed.

Remote access to the UoM DSH is via Virtual Desktop Infrastructure technology to ensure the data is only processed within, and never leaves the DSH virtual environment. Due to this ‘painted screen’ approach, no remnants of the data are ever stored on the client device through mechanisms such as temp files or browser caches.

Data will be accessed by students enrolled for a postgraduate course (e.g. Masters and/or PhD) with MFT. Any student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to MFT's policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of MFT. MFT would be responsible and liable for any work carried out by students. These students may only work on the Data for the purposes described in this DSA.

The postgraduate students will not be accessing the data remotely.

All other data releases will be made in line with HES analysis guidance, aggregated with small numbers under 7 suppressed. No NHS England data will be transferred outside the UK.

Expected output

When processing is complete, outputs will include:

1. Submission to peer review journals (for example Circulation, European Heart Journal, European Journal of Heart Failure). A submission to ESC Heart Failure journal has been submitted awaiting peer-review.

2. Presentations at:

a) Internal meetings at Manchester University NHS Foundation Trust (MFT), the University of Manchester (UoM) and Medtronic.

b) Seminars and workshops at academic events (where appropriate)

c) National and international academic conferences. Preliminary findings were presented at;(1) European Society of Cardiology Congress 2022, platform presentation. Use of a device-based remote management heart failure care pathway is associated with reduced hospitalization and improved patient outcomes: TriageHF Plus real-world evaluation.

(2) American Heart Association Scientific Sessions 2021, platform presentation. Use of a Novel Cardiac Implantable Electronic Device Digital Care Pathway (TriageHF-Plus) is Associated With a Reduction in All-Cause Unplanned Hospitalizations.

(3) Europhysiology conference 2022, poster presentation. Physical activity measured by cardiac devices predicts frailty, hospitalisation and death in older people.

(4) European Union Geriatric Medicine Society meeting 2023, poster presentation. Remotely monitored physical activity from older people with cardiac devices associates with frailty, physical functioning, hospitalisation and death

Of note, these presentations have received significant media exposure:

(1) The Telegraph article: The ‘game-changing’ heart implant that can slash hospital admissions,

(2) British Heart Foundation webpage news article: Remote heart alert system saves heart failure patients

from hospitalisation,

(3) The Times article: Heart implant transmits patient data to hospital for instant care alerts,

(4) British Heart Foundation Heart Matters magazine,

(5) The Telegraph article: How advances in technology and data from pacemakers alert doctors about

heart failure patients who may benefit from medical attention.

d) Patient engagement events e.g. open lectures and talks (http://www.engagement.manchester.ac.uk/about/index.html)

e) Local meetings, held in Greater Manchester, will be attended by clinicians, healthcare practitioners, healthcare scientists, clinical managers, heart failure charities and patients.

3. A lay summary of results for patients and interested non-academic parties disseminated via:

a) Research Webpage for Manchester Heart Centre.

b) Study website (details provided to all study participants) (https://research.cmft.nhs.uk/research/manchester-royal-infirmary/manchester-heart-centre/clinical-studies/triage-hf-plus-evaluation)

c) MFT, UoM and other publicly accessible websites (e.g. Medtronic)

d) Results may be disseminated in the form of progress reports for interested parties

4. A PhD thesis by co-principal investigator at MFT and British Heart Foundation Clinical Research Training Fellow at University of Manchester/ MFT. Data originating from NHS England may be included in this PhD thesis which is a published document. This thesis has been submitted.

Dissemination of work will continue as results become available.

No data presented will be identifiable. Aggregate level data with small numbers suppressed will be presented in all outputs in line with the HES analysis guide to avoid risk of re-identification. For example, any data with less than 5 patients will not be shown.

Through the outputs stated above, the results of this evaluation will be disseminated to a target audience of researchers, data scientists, academic groups, innovative technology-focused organisations and research participants. All involved organisations have established links with a wide variety of communities and will help ensure output is brought to the attention of policy makers and industry collaborators. Interested audiences will be health professionals but will not be restricted i.e. results will be available to the public.

MFT has a research collaboration agreement in place with Medtronic outlining data and knowledge ownership and access rights. Results will be shared with all stakeholders (including Medtronic) but Medtronic will only see aggregated outputs of the NHS England data with small number suppression. Stakeholders will have no influence on the evaluation results.

Expected measurable benefits

The main benefit of the TRIAGE study will be a greater understanding of the workload associated with the Triage-HF Plus Clinical Pathway. Previous work has demonstrated that the heart failure risk score used to guide the pathway can effectively identify heart failure patients at increased risk of hospitalisation and death. This study will provide information to describe practical implications of implementing the pathway in clinical practice – required by healthcare providers to evaluate the risks and benefits of changing clinical workflows.

If results show low workforce burden, this may contribute to a change in national guidance, for example upgrading recommendations to more strongly support remote monitoring is incorporated into routine clinical practice. For example, remote monitoring may replace traditional face-to-face clinical review in specified circumstances. If results show high workforce burden, this may contribute to reconfiguration of clinical services.

This will benefit patients by improving patient care, and the NHS by evaluating the best service delivery. The Data Controller would anticipate new sites would take 2-3 years to fully implement the Triage HF Plus Pathway and evaluate significant new changes.

Improved knowledge of the clinical, organisational and financial implications of implementing the Triage-HF Plus clinical pathway will be of benefit to health and social care as outlined below:

Researchers: Improved knowledge in this research area opens new avenues of research within the field of device diagnostic/heart failure research. As outlined above this may justify modifying clinical pathways and facilitate the rapid scale up implementation of this pathway across the UK. In addition, component aspects of the TriageHF algorithm (for example, physical activity) could be used as a stand-alone metric to target evidence-based interventions.

Clinicians: TRIAGE will provide greater understanding of how implementation of the Triage HF Plus Clinical Pathway would affect how individual providers and clinicians serve their patients. Results may influence other Cardiology clinical departments both national and international in terms of how they integrate remote monitoring into their workstreams. Dissemination of work to improve knowledge of relevant health professionals throughout course of agreement.

Patients: This work will hopefully lead to improved patient care. This may not occur as a direct result of this evaluation, rather further down the line as a results of service improvement projects.

NICE Diagnostics Assessment Programme “Algorithm-based remote monitoring of heart failure risk data in people with cardiac implantable electronic devices” is currently underway, demonstrating how this research is directly contributing to review of national guidance. Results are expected throughout course of agreement.

Benefits reported so far

Yielded benefits to date as a result of preliminary data are summarised here.

MFT have identified that the TriageHF Plus pathway is:

1. Associated with reduced risk of all-cause hospitalisation (results disseminated through peer-review publication and presented at academic conferences)

Ahmed, F. Z., Sammut-Powell, C., Martin, G. P., Callan, P., Cunnington, C., Kahn, M., Kale, M., Weldon, T., Harwood, R., Fullwood, C., Gerritse, B., Lanctin, D., Soken, N., Campbell, N. G., and Taylor, J. K. (2024) Association of a device-based remote management heart failure pathway with outcomes: TriageHF Plus real-world evaluation. ESC Heart Failure, 11: 2637–2647. https://doi.org/10.1002/ehf2.14821.

2. Cost-effective

- Results contributed to new NICE guidelines on remote monitoring las year:

https://www.nice.org.uk/guidance/dg61

- A full academic manuscript is currently under peer-review with the Heart journal

Results have already influenced guidelines by significantly contributing towards the NICE Diagnostics Assessment Programme “Algorithm-based remote monitoring of heart failure risk data in people with cardiac implantable electronic devices”, which were published in 2024. As a result, remote monitoring pathways such as TriageHF Plus are now recommended as an option for patients with heart failure and devices.

A criticism of this research has been the impact of COVID-19 on follow-up, and whether the timelines reflect the post-COVID timeframe. MFT therefore extended the follow-up period to end 30th September 2025 (recruitment now closed).

Datasets on the current version

Legal basis for provision: Health and Social Care Act 2012 – s261(2)(a); Health and Social Care Act 2012 – s261(2)(c)

Datasets approved under DARS-NIC-401890-W6Q8W-v3.7
Dataset	Type of data	Sensitivity	Frequency	Confidential data
Civil Registrations of Death	Identifiable	Sensitive	One-Off	Consent (Reasonable Expectation)
Civil Registrations of Death - Secondary Care Cut	Identifiable	Sensitive	One-Off	Consent (Reasonable Expectation)
Emergency Care Data Set (ECDS)	Identifiable	Sensitive	One-Off	Consent (Reasonable Expectation)
HES:Civil Registration (Deaths) bridge	Identifiable	Non-Sensitive	Ongoing	Consent (Reasonable Expectation)
Hospital Episode Statistics Accident and Emergency (HES A and E)	Identifiable	Non-Sensitive	One-Off	Consent (Reasonable Expectation)
Hospital Episode Statistics Admitted Patient Care (HES APC)	Identifiable	Non-Sensitive	One-Off	Consent (Reasonable Expectation)
Hospital Episode Statistics Outpatients (HES OP)	Identifiable	Sensitive	One-Off	Consent (Reasonable Expectation)

Files released

Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.

Patient opt-outs were not applied to any of the 49 files released under this agreement, across every version. About opt-outs

Files released against version 3.7 of this agreement, summarised by dataset.

Files released under DARS-NIC-401890-W6Q8W-v3.7
Dataset	Files	First released	Last released	Opt-outs applied
Emergency Care Data Set (ECDS)	4	July 2026	July 2026	No
Hospital Episode Statistics Admitted Patient Care (HES APC)	4	July 2026	July 2026	No
Hospital Episode Statistics Outpatients (HES OP)	4	July 2026	July 2026	No
Civil Registrations of Death	1	July 2026	July 2026	No

Version history

The register lists each renewal of this agreement as a separate row. This site has 4 versions.

DARS-NIC-401890-W6Q8W-v3.7 7 May 2026 to 6 May 2029

Title: Prospective Triage HF+ Evaluation: What is the workload burden associated with using the Triage HF+ care pathway?
Commercial: Yes
Sublicensing: No
Datasets: 7
Files released: 13

Datasets: Civil Registrations of Death; Civil Registrations of Death - Secondary Care Cut; Emergency Care Data Set (ECDS); HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP)

What changed from DARS-NIC-401890-W6Q8W-v2.7

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-401890-W6Q8W-v2.7
Field	Was	Became
Start date	~~2024-05-07~~	2026-05-07
End date	~~2026-05-06~~	2029-05-06
HES:Civil Registration (Deaths) bridge: legal basis	~~Not stated~~	Health and Social Care Act 2012 – s261(2)(c)

Datasets: + Civil Registrations of Death

Objective for processing

[7 paragraphs unchanged] Data from NHS England is requested to provide pseudonymised record-level information about [38 words unchanged] (APC), HES Accident & Emergency (A&E) and HES Outpatients data. Civil Registration ~~(Deaths) Secondary Care Cut~~ Deaths will provide the required mortality information. [9 paragraphs unchanged]

Processing activities

[2 paragraphs unchanged] Linked pseudonymised NHS England health data (Emergency Care Data Set (ECDS), Hospital [6 words unchanged] (APC), HES Accident & Emergency (A&E), HES Outpatients data and Civil Registration ~~(Deaths) Secondary Care Cut)~~ Deaths will be provided to MFT via an encrypted transfer system. Access to [60 words unchanged] of MFT and have been appropriately trained in data protection and confidentiality. The received NHS England data will be checked and cleaned/formatted at MFT. [55 words unchanged] this process also requires the same security processes as per on-site access. ~~It is not possible to download any data from remote access onto external computers. This arrangement is in line with the NHS England Data Access Request Service Temporary Remote Access Guidance.~~ [5 paragraphs unchanged] Data analysis will be performed using software within the DSH (mainly Microsoft [7 words unchanged] Data will be stored until one year after the final data dissemination, ~~anticipated October 2024,~~ providing enough time to complete all analysis and publish study findings. A valid data sharing agreement will be maintained until all such analysis has been completed. [4 paragraphs unchanged]

Expected output

[10 paragraphs unchanged] (1) The Telegraph article: The ‘game-changing’ heart implant that can slash hospital admissions, ~~August~~ ~~2022.~~ [1 paragraph unchanged] from hospitalisation, ~~August 2022~~ (3) The Times article: Heart implant transmits patient data to hospital for instant care alerts, ~~August 2022.~~ (4) British Heart Foundation Heart Matters magazine, ~~June 2022.~~ [1 paragraph unchanged] heart failure patients who may benefit from medical attention. ~~February 2022.~~ [7 paragraphs unchanged] 4. A PhD thesis by co-principal investigator at MFT and British Heart [19 words unchanged] this PhD thesis which is a published document. This thesis has been ~~submitted and will be publicly available from February 2024.~~ submitted. [4 paragraphs unchanged]

Expected measurable benefits

[2 paragraphs unchanged] This will benefit patients by improving patient care, and the NHS by evaluating the best service delivery. We The Data Controller would anticipate new sites would take 2-3 years to fully implement the Triage HF Plus Pathway and evaluate significant new changes. [1 paragraph unchanged] Researchers: Improved knowledge in this research area opens new avenues of research [41 words unchanged] activity) could be used as a stand-alone metric to target evidence-based interventions. ~~Publication and dissemination of data is expected to commence in 2024.~~ Clinicians: TRIAGE will provide greater understanding of how implementation of the Triage [24 words unchanged] international in terms of how they integrate remote monitoring into their workstreams. ~~Target date:~~ Dissemination of work to improve knowledge of relevant health ~~professionals: 2024.~~ professionals throughout course of agreement. [1 paragraph unchanged] ~~2023 update:~~ NICE Diagnostics Assessment Programme “Algorithm-based remote monitoring of heart failure risk data [13 words unchanged] research is directly contributing to review of national guidance. Results are expected ~~in 2024.~~ throughout course of agreement.

Benefits reported

[1 paragraph unchanged] We MFT have identified that the TriageHF Plus pathway is: 1. Associated with reduced risk of all-cause hospitalisation (results disseminated through peer-review publication and presented at academic ~~conference, publication submitted for peer-review)~~ conferences) ~~2. Cost-effective (preliminary results submitted to NICE Diagnostics Assessment Programme, not yet presented/published)~~ Ahmed, F. Z., Sammut-Powell, C., Martin, G. P., Callan, P., Cunnington, C., Kahn, M., Kale, M., Weldon, T., Harwood, R., Fullwood, C., Gerritse, B., Lanctin, D., Soken, N., Campbell, N. G., and Taylor, J. K. (2024) Association of a device-based remote management heart failure pathway with outcomes: TriageHF Plus real-world evaluation. ESC Heart Failure, 11: 2637–2647. https://doi.org/10.1002/ehf2.14821. These results will feed into the ongoing NICE Diagnostics Assessment Programme “Algorithm-based remote monitoring of heart failure risk data in people with cardiac implantable electronic devices”, demonstrating how this research is directly contributing to review of national guidance. Results are expected in 2024. 2. Cost-effective ~~In addition, the TriageHF Plus study has expanded to include an additional three sites across Greater Manchester based on the promising preliminary results presented so far.~~ - Results contributed to new NICE guidelines on remote monitoring las year: https://www.nice.org.uk/guidance/dg61 - A full academic manuscript is currently under peer-review with the Heart journal Results have already influenced guidelines by significantly contributing towards the NICE Diagnostics Assessment Programme “Algorithm-based remote monitoring of heart failure risk data in people with cardiac implantable electronic devices”, which were published in 2024. As a result, remote monitoring pathways such as TriageHF Plus are now recommended as an option for patients with heart failure and devices. A criticism of this research has been the impact of COVID-19 on follow-up, and whether the timelines reflect the post-COVID timeframe. MFT therefore extended the follow-up period to end 30th September 2025 (recruitment now closed).

DARS-NIC-401890-W6Q8W-v2.7 7 May 2024 to 6 May 2026

Title: Prospective Triage HF+ Evaluation: What is the workload burden associated with using the Triage HF+ care pathway?
Commercial: Yes
Sublicensing: No
Datasets: 6
Files released: 17

Datasets: Civil Registrations of Death - Secondary Care Cut; Emergency Care Data Set (ECDS); HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP)

What changed from DARS-NIC-401890-W6Q8W-v1.6

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-401890-W6Q8W-v1.6
Field	Was	Became
Start date	~~2022-09-02~~	2024-05-07
End date	~~2024-02-17~~	2026-05-06
Civil Registrations of Death - Secondary Care Cut: type of data	~~Anonymised - ICO Code Compliant~~	Identifiable
Emergency Care Data Set (ECDS): type of data	~~Anonymised - ICO Code Compliant~~	Identifiable
HES:Civil Registration (Deaths) bridge: type of data	~~Anonymised - ICO Code Compliant~~	Identifiable
Hospital Episode Statistics Accident and Emergency (HES A and E): type of data	~~Anonymised - ICO Code Compliant~~	Identifiable
Hospital Episode Statistics Admitted Patient Care (HES APC): type of data	~~Anonymised - ICO Code Compliant~~	Identifiable
Hospital Episode Statistics Outpatients (HES OP): type of data	~~Anonymised - ICO Code Compliant~~	Identifiable

Objective for processing

[7 paragraphs unchanged] Data from NHS ~~Digital~~ England is requested to provide pseudonymised record-level information about both healthcare utilisation and [44 words unchanged] Civil Registration (Deaths) Secondary Care Cut will provide the required mortality information. NHS ~~Digital~~ England HES data is required because many participants’ local hospitals will be elsewhere [39 words unchanged] hospital attendances. Data requested will be minimised to the 24 months prior ~~to,~~ to recruitment, and up to 3 years after ~~date~~ completion of ~~recruitment for each participant.~~ the evaluation. Clinical data requested has been reviewed by 2 clinical researchers at Manchester [39 words unchanged] is required to be record-level in order to perform a meaningful analysis. [1 paragraph unchanged] The TRIAGE study is a stand-alone study. It is not part of a wider project or collaboration. No follow-up work is currently planned. NHS ~~Digital~~ England data collected as part of this application will be used as described [24 words unchanged] is completing their thesis as a student of the University of Manchester. MFT are the sole data controller for this study who also process [31 words unchanged] Hospital Clinical Service platform. Medtronic have no access to record level NHS ~~Digital~~ England data and have no influence over study results or outputs generated. They [29 words unchanged] workforce burden, and guidelines change to support the uptake of this pathway. TRIAGE is sponsored by MFT in partnership with Medtronic Limited. Pennine Acute Hospitals NHS Trust and Wythenshawe hospital will provide cohort identifiers to MFT to send to NHS ~~Digital.~~ England. These organisations are involved in the clinical evaluation of patients within the overall study but do not have access to NHS ~~Digital~~ England data. The Article 6 UK GDPR justification for processing is 6(1)(e): ‘processing is necessary for the performance [8 words unchanged] interest or in the exercise of official authority vested in the controller’ The collection of data from NHS ~~Digital~~ England is essential for the completion of the TRIAGE study. This is in [71 words unchanged] be used as part of the TRIAGE study to advance academic knowledge. The Article 9 UK GDPR justification for processing is 9(2)(j): ‘processing is necessary for archiving purposes [48 words unchanged] to safeguard the fundamental rights and the interests of the data subject.’ [1 paragraph unchanged]

Processing activities

~~** AMENDEMENT June 2022**~~ Under v1, MFT are requesting linked data may be transferred back to MFT from the DSH to facilitate analysis/checking by substantive employees from Manchester University NHS Foundation Trust during different stages of the analysis process. This will be undertaken in line with processes outlined in this agreement i.e. secure file transfer directly onto the MFT server. [1 paragraph unchanged] Information provided to NHS ~~Digital~~ England will be record-level identifiable patient data. Personal data for each study participant will be provided to NHS ~~Digital~~ England by Manchester University NHS Foundation Trust (MFT). Data transfer will occur via [25 words unchanged] trial, and personal identifiers only: NHS Number, Date of Birth, Sex, Postcode. Linked pseudonymised NHS ~~Digital~~ England health data (Emergency Care Data Set (ECDS), Hospital Episode Statistics (HES) Admitted [46 words unchanged] access requires trust usernames and passwords to access the MFT server. NHS ~~Digital~~ England data will be stored within a specified password-protected sub-folder, for which access [19 words unchanged] of MFT and have been appropriately trained in data protection and confidentiality. The received NHS ~~Digital~~ England data will be checked and cleaned/formatted at MFT. This will occur either [73 words unchanged] access onto external computers. This arrangement is in line with the NHS ~~Digital~~ England Data Access Request Service Temporary Remote Access Guidance. After checking and cleaning of the NHS ~~Digital~~ England data, it will be combined with other evaluation data (cardiac device data [24 words unchanged] database for analysis. It will not be linked with any other databases. [1 paragraph unchanged] Analysis of the linked de-identified data will assess the workforce burden associated [23 words unchanged] involve exploration of a number of secondary objectives as previously described. NHS ~~Digital~~ England data regarding (1) accident and emergency attendances (2) admitted care episodes, (3) [9 words unchanged] a meaningful analysis which will influence provision of care in the future. The DSH is purpose built for the secure management and processing of [109 words unchanged] MFT will have access to the SPN-coded database containing record level NHS ~~Digital~~ England data. [3 paragraphs unchanged] ~~All other data releases will be made in line with HES analysis guidance, aggregated with small numbers under 7 suppressed. No NHS Digital data will be transferred outside the UK.~~ Data will be accessed by students enrolled for a postgraduate course (e.g. Masters and/or PhD) with MFT. Any student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to MFT's policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of MFT. MFT would be responsible and liable for any work carried out by students. These students may only work on the Data for the purposes described in this DSA. The postgraduate students will not be accessing the data remotely. All other data releases will be made in line with HES analysis guidance, aggregated with small numbers under 7 suppressed. No NHS England data will be transferred outside the UK.

Expected output

[1 paragraph unchanged] 1. Submission to peer review journals (for example Circulation, European Heart Journal, European Journal of Heart ~~Failure)~~ Failure). A submission to ESC Heart Failure journal has been submitted awaiting peer-review. [3 paragraphs unchanged] c) National and international academic conferences (for example Heart Rhythm Society, Heart Rhythm Congress, European Society of Cardiology). A member of the study team will present the results of TRIAGE during at least one international cardiology congress. c) National and international academic conferences. Preliminary findings were presented at;(1) European Society of Cardiology Congress 2022, platform presentation. Use of a device-based remote management heart failure care pathway is associated with reduced hospitalization and improved patient outcomes: TriageHF Plus real-world evaluation. (2) American Heart Association Scientific Sessions 2021, platform presentation. Use of a Novel Cardiac Implantable Electronic Device Digital Care Pathway (TriageHF-Plus) is Associated With a Reduction in All-Cause Unplanned Hospitalizations. (3) Europhysiology conference 2022, poster presentation. Physical activity measured by cardiac devices predicts frailty, hospitalisation and death in older people. (4) European Union Geriatric Medicine Society meeting 2023, poster presentation. Remotely monitored physical activity from older people with cardiac devices associates with frailty, physical functioning, hospitalisation and death Of note, these presentations have received significant media exposure: (1) The Telegraph article: The ‘game-changing’ heart implant that can slash hospital admissions, August 2022. (2) British Heart Foundation webpage news article: Remote heart alert system saves heart failure patients from hospitalisation, August 2022 (3) The Times article: Heart implant transmits patient data to hospital for instant care alerts, August 2022. (4) British Heart Foundation Heart Matters magazine, June 2022. (5) The Telegraph article: How advances in technology and data from pacemakers alert doctors about heart failure patients who may benefit from medical attention. February 2022. [4 paragraphs unchanged] b) ~~Letters/emails~~ Study website (details provided to all study ~~participants~~ participants) (https://research.cmft.nhs.uk/research/manchester-royal-infirmary/manchester-heart-centre/clinical-studies/triage-hf-plus-evaluation) [2 paragraphs unchanged] 4. A PhD thesis by co-principal investigator at MFT and British Heart Foundation Clinical Research Training Fellow at University of Manchester/ MFT. Data originating from NHS ~~Digital~~ England may be included in this PhD thesis which is a published document. This thesis has been submitted and will be publicly available from February 2024. ~~The target time for release of these outputs is October 2023.~~ Dissemination of work will continue as results become available. No data presented will be identifiable. Aggregate level data with small numbers [14 words unchanged] to avoid risk of re-identification. For example, any data with less than 7 5 patients will not be shown. [1 paragraph unchanged] MFT has a research collaboration agreement in place with Medtronic outlining data [13 words unchanged] (including Medtronic) but Medtronic will only see aggregated outputs of the NHS ~~Digital~~ England data with small number suppression. Stakeholders will have no influence on the evaluation results.

Expected measurable benefits

[4 paragraphs unchanged] Researchers: Improved knowledge in this research area opens new avenues of research [18 words unchanged] facilitate the rapid scale up implementation of this pathway across the UK. In addition, component aspects of the TriageHF algorithm (for example, physical activity) could be used as a stand-alone metric to target evidence-based interventions. Publication and dissemination of data is expected to commence in ~~October 2023.~~ 2024. Clinicians: TRIAGE will provide greater understanding of how implementation of the Triage [36 words unchanged] Target date: Dissemination of work to improve knowledge of relevant health professionals: ~~October 2023.~~ 2024. [1 paragraph unchanged] 2023 update: NICE Diagnostics Assessment Programme “Algorithm-based remote monitoring of heart failure risk data in people with cardiac implantable electronic devices” is currently underway, demonstrating how this research is directly contributing to review of national guidance. Results are expected in 2024.

Benefits reported

~~No outputs have been yielded to date as not all data has been disseminated and the data is still being processed, and MFT and UoM have not had a chance to received feedback post outputs.~~ Yielded benefits to date as a result of preliminary data are summarised here. We have identified that the TriageHF Plus pathway is: 1. Associated with reduced risk of all-cause hospitalisation (results presented at academic conference, publication submitted for peer-review) 2. Cost-effective (preliminary results submitted to NICE Diagnostics Assessment Programme, not yet presented/published) These results will feed into the ongoing NICE Diagnostics Assessment Programme “Algorithm-based remote monitoring of heart failure risk data in people with cardiac implantable electronic devices”, demonstrating how this research is directly contributing to review of national guidance. Results are expected in 2024. In addition, the TriageHF Plus study has expanded to include an additional three sites across Greater Manchester based on the promising preliminary results presented so far.

Objective for processing

1) Comparison of frequency and type of clinical touchpoints and patient outcomes pre-Triage-HF Plus (current state) and post-Triage-HF Plus Implementation (future state, prospective).

2) Estimation of cost of Triage-HF Plus care pathway at each site

3) Exploration of relationships between Triage-HF with patient demographics and heart failure events

4) Exploration of relationships between Triage-HF with patient demographics and non-heart failure events such as frailty

Data from NHS England is requested to provide pseudonymised record-level information about both healthcare utilisation and mortality for each participant, allowing evaluation of the efficacy of the Triage-HF Plus pathway. Healthcare utilisation data will be provided from the Emergency Care Data Set (ECDS), Hospital Episode Statistics (HES) Admitted Patient Care (APC), HES Accident & Emergency (A&E) and HES Outpatients data. Civil Registration (Deaths) Secondary Care Cut will provide the required mortality information.

Expected output

When processing is complete, outputs will include:

2. Presentations at:

a) Internal meetings at Manchester University NHS Foundation Trust (MFT), the University of Manchester (UoM) and Medtronic.

b) Seminars and workshops at academic events (where appropriate)

(3) Europhysiology conference 2022, poster presentation. Physical activity measured by cardiac devices predicts frailty, hospitalisation and death in older people.

Of note, these presentations have received significant media exposure:

(1) The Telegraph article: The ‘game-changing’ heart implant that can slash hospital admissions, August

2022.

(2) British Heart Foundation webpage news article: Remote heart alert system saves heart failure patients

from hospitalisation, August 2022

(3) The Times article: Heart implant transmits patient data to hospital for instant care alerts, August 2022.

(4) British Heart Foundation Heart Matters magazine, June 2022.

(5) The Telegraph article: How advances in technology and data from pacemakers alert doctors about

heart failure patients who may benefit from medical attention. February 2022.

d) Patient engagement events e.g. open lectures and talks (http://www.engagement.manchester.ac.uk/about/index.html)

e) Local meetings, held in Greater Manchester, will be attended by clinicians, healthcare practitioners, healthcare scientists, clinical managers, heart failure charities and patients.

3. A lay summary of results for patients and interested non-academic parties disseminated via:

a) Research Webpage for Manchester Heart Centre.

b) Study website (details provided to all study participants) (https://research.cmft.nhs.uk/research/manchester-royal-infirmary/manchester-heart-centre/clinical-studies/triage-hf-plus-evaluation)

c) MFT, UoM and other publicly accessible websites (e.g. Medtronic)

d) Results may be disseminated in the form of progress reports for interested parties

Dissemination of work will continue as results become available.

Benefits reported

Yielded benefits to date as a result of preliminary data are summarised here.

We have identified that the TriageHF Plus pathway is:

1. Associated with reduced risk of all-cause hospitalisation (results presented at academic conference, publication submitted for peer-review)

2. Cost-effective (preliminary results submitted to NICE Diagnostics Assessment Programme, not yet presented/published)

These results will feed into the ongoing NICE Diagnostics Assessment Programme “Algorithm-based remote monitoring of heart failure risk data in people with cardiac implantable electronic devices”, demonstrating how this research is directly contributing to review of national guidance. Results are expected in 2024.

In addition, the TriageHF Plus study has expanded to include an additional three sites across Greater Manchester based on the promising preliminary results presented so far.

DARS-NIC-401890-W6Q8W-v1.6 2 September 2022 to 17 February 2024

Title: Prospective Triage HF+ Evaluation: What is the workload burden associated with using the Triage HF+ care pathway?
Commercial: Yes
Sublicensing: No
Datasets: 6
Files released: 0

What changed from DARS-NIC-401890-W6Q8W-v0.14

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-401890-W6Q8W-v0.14
Field	Was	Became
Start date	~~2021-02-18~~	2022-09-02

Objective for processing

[6 paragraphs unchanged] For the TRIAGE study, patients ~~are~~ were initially being recruited from three hospital sites across North West England, with an initial recruitment target of a single cohort of 450 participants. Enrolment of new patients into the registry is now proposed to end on 30th June 2024, with follow-up (entry of phone call assessment into the eCRF) to end on 30th June 2025. The first patient was recruited in September 2019. Enrolment of new patients into the registry is proposed to end on 30th June 2024, with follow-up (entry of phone call assessment into the eCRF) to end on 30th June 2025. Inclusion criteria identify patients 18 years or older with a compatible Medtronic cardiac device. Patients must be able to provide written, informed consent in the English language. [3 paragraphs unchanged] The TRIAGE study is a stand-alone study. It is not part of [20 words unchanged] will be used as described above for the TRIAGE study and for ~~potential~~ inclusion in an affiliated PhD project only. The PhD candidate is a [5 words unchanged] is completing their thesis as a student of the University of Manchester. MFT are the sole data controller for this ~~study. MFT and~~ study who also process the data. The University of Manchester ~~will be joint~~ is also a data ~~processors.~~ processor. Medtronic Limited are the funder and commercial partner for the study. They [62 words unchanged] workforce burden, and guidelines change to support the uptake of this pathway. [5 paragraphs unchanged]

Processing activities

** AMENDEMENT June 2022** Under v1, MFT are requesting linked data may be transferred back to MFT from the DSH to facilitate analysis/checking by substantive employees from Manchester University NHS Foundation Trust during different stages of the analysis process. This will be undertaken in line with processes outlined in this agreement i.e. secure file transfer directly onto the MFT server. [5 paragraphs unchanged] In order to facilitate the movement of data out of MFT to [98 words unchanged] database will be transferred into the UoM Data Safe Haven (DSH) and ~~remain in the DSH for all analysis.~~ (on request from MFT), processed data will be transferred back to MFT to facilitate additional analyses. There will be no attempt to re-identify individual participants. [3 paragraphs unchanged] Data analysis will be performed using software within the DSH (mainly Microsoft Excel, SPSS, R, ~~GraphPad).~~ GraphPad) and at MFT. Data will be stored ~~in the DSH~~ until one year after the final data dissemination, anticipated October 2024, providing [13 words unchanged] sharing agreement will be maintained until all such analysis has been completed. [2 paragraphs unchanged]

Benefits reported

~~Yielded Benefits is not a requirement for new applications.~~ No outputs have been yielded to date as not all data has been disseminated and the data is still being processed, and MFT and UoM have not had a chance to received feedback post outputs.

Unchanged: Expected output, Expected measurable benefits.

Objective for processing

1) Comparison of frequency and type of clinical touchpoints and patient outcomes pre-Triage-HF Plus (current state) and post-Triage-HF Plus Implementation (future state, prospective).

2) Estimation of cost of Triage-HF Plus care pathway at each site

3) Exploration of relationships between Triage-HF with patient demographics and heart failure events

4) Exploration of relationships between Triage-HF with patient demographics and non-heart failure events such as frailty

Data from NHS Digital is requested to provide pseudonymised record-level information about both healthcare utilisation and mortality for each participant, allowing evaluation of the efficacy of the Triage-HF Plus pathway. Healthcare utilisation data will be provided from the Emergency Care Data Set (ECDS), Hospital Episode Statistics (HES) Admitted Patient Care (APC), HES Accident & Emergency (A&E) and HES Outpatients data. Civil Registration (Deaths) Secondary Care Cut will provide the required mortality information.

NHS Digital HES data is required because many participants’ local hospitals will be elsewhere in the region and the local data will not provide the necessary complete set of information. There are no less intrusive ways of achieving this data reliably. It is not feasible to rely on patients to remember dates of hospital attendances. Data requested will be minimised to the 24 months prior to, and up to 3 years after date of recruitment for each participant. Clinical data requested has been reviewed by 2 clinical researchers at Manchester University NHS Foundation Trust (MFT - previously known as Central Manchester NHS Foundation Trust), and the University of Manchester data analysis team. This is to ensure that the data is both minimised and sufficient for achieving study outcomes. Data is required to be record-level in order to perform a meaningful analysis.

The TRIAGE study is a stand-alone study. It is not part of a wider project or collaboration. No follow-up work is currently planned. NHS Digital data collected as part of this application will be used as described above for the TRIAGE study and for inclusion in an affiliated PhD project only. The PhD candidate is a substantive employee of MFT who is completing their thesis as a student of the University of Manchester.

MFT are the sole data controller for this study who also process the data. The University of Manchester is also a data processor. Medtronic Limited are the funder and commercial partner for the study. They provide device data to MFT via the One Hospital Clinical Service platform. Medtronic have no access to record level NHS Digital data and have no influence over study results or outputs generated. They will have access to aggregated data with small numbers suppressed. Medtronic may benefit from the study if results show that the associated Triage HF Plus clinical pathway reduces NHS workforce burden, and guidelines change to support the uptake of this pathway.

TRIAGE is sponsored by MFT in partnership with Medtronic Limited. Pennine Acute Hospitals NHS Trust and Wythenshawe hospital will provide cohort identifiers to MFT to send to NHS Digital. These organisations are involved in the clinical evaluation of patients within the overall study but do not have access to NHS Digital data.

The Article 6 GDPR justification for processing is 6(1)(e): ‘processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller’

The collection of data from NHS Digital is essential for the completion of the TRIAGE study. This is in the public interest as: (1) results from the TRIAGE study will advance academic and clinical knowledge and understanding of workload burden associated with, and efficacy of the Triage-HF Plus care pathway, (2) results from the TRIAGE study will in likelihood lead to either further clinical studies or direct change in clinical service provision with the aim of improving patient care and (3) all participants have expressed willingness of their data to be used as part of the TRIAGE study to advance academic knowledge.

The Article 9 GDPR justification for processing is 9(2)(j): ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.’

Expected output

When processing is complete, outputs will include:

1. Submission to peer review journals (for example Circulation, European Heart Journal, European Journal of Heart Failure)

2. Presentations at:

a) Internal meetings at Manchester University NHS Foundation Trust (MFT), the University of Manchester (UoM) and Medtronic.

b) Seminars and workshops at academic events (where appropriate)

c) National and international academic conferences (for example Heart Rhythm Society, Heart Rhythm Congress, European Society of Cardiology). A member of the study team will present the results of TRIAGE during at least one international cardiology congress.

d) Patient engagement events e.g. open lectures and talks (http://www.engagement.manchester.ac.uk/about/index.html)

e) Local meetings, held in Greater Manchester, will be attended by clinicians, healthcare practitioners, healthcare scientists, clinical managers, heart failure charities and patients.

3. A lay summary of results for patients and interested non-academic parties disseminated via:

a) Research Webpage for Manchester Heart Centre.

b) Letters/emails to study participants

c) MFT, UoM and other publicly accessible websites (e.g. Medtronic)

d) Results may be disseminated in the form of progress reports for interested parties

4. A PhD thesis by co-principal investigator at MFT and British Heart Foundation Clinical Research Training Fellow at University of Manchester/ MFT. Data originating from NHS Digital may be included in this PhD thesis which is a published document.

The target time for release of these outputs is October 2023.

MFT has a research collaboration agreement in place with Medtronic outlining data and knowledge ownership and access rights. Results will be shared with all stakeholders (including Medtronic) but Medtronic will only see aggregated outputs of the NHS Digital data with small number suppression. Stakeholders will have no influence on the evaluation results.

Benefits reported

No outputs have been yielded to date as not all data has been disseminated and the data is still being processed, and MFT and UoM have not had a chance to received feedback post outputs.

DARS-NIC-401890-W6Q8W-v0.14 18 February 2021 to 17 February 2024

Title: Prospective Triage HF+ Evaluation: What is the workload burden associated with using the Triage HF+ care pathway?
Commercial: Yes
Sublicensing: No
Datasets: 6
Files released: 19

Objective for processing

1) Comparison of frequency and type of clinical touchpoints and patient outcomes pre-Triage-HF Plus (current state) and post-Triage-HF Plus Implementation (future state, prospective).

2) Estimation of cost of Triage-HF Plus care pathway at each site

3) Exploration of relationships between Triage-HF with patient demographics and heart failure events

4) Exploration of relationships between Triage-HF with patient demographics and non-heart failure events such as frailty

For the TRIAGE study, patients are being recruited from three hospital sites across North West England, with an initial recruitment target of a single cohort of 450 participants. The first patient was recruited in September 2019. Inclusion criteria identify patients 18 years or older with a compatible Medtronic cardiac device. Patients must be able to provide written, informed consent in the English language.

The TRIAGE study is a stand-alone study. It is not part of a wider project or collaboration. No follow-up work is currently planned. NHS Digital data collected as part of this application will be used as described above for the TRIAGE study and for potential inclusion in an affiliated PhD project only. The PhD candidate is a substantive employee of MFT who is completing their thesis as a student of the University of Manchester.

MFT are the sole data controller for this study. MFT and the University of Manchester will be joint data processors. Medtronic Limited are the funder and commercial partner for the study. They provide device data to MFT via the One Hospital Clinical Service platform. Medtronic have no access to record level NHS Digital data and have no influence over study results or outputs generated. They will have access to aggregated data with small numbers suppressed. Medtronic may benefit from the study if results show that the associated Triage HF Plus clinical pathway reduces NHS workforce burden, and guidelines change to support the uptake of this pathway.

TRIAGE is sponsored by MFT in partnership with Medtronic Limited. Pennine Acute Hospitals NHS Trust and Wythenshawe hospital will provide cohort identifiers to MFT to send to NHS Digital. These organisations are involved in the clinical evaluation of patients within the overall study but do not have access to NHS Digital data.

Expected output

When processing is complete, outputs will include:

1. Submission to peer review journals (for example Circulation, European Heart Journal, European Journal of Heart Failure)

2. Presentations at:

a) Internal meetings at Manchester University NHS Foundation Trust (MFT), the University of Manchester (UoM) and Medtronic.

b) Seminars and workshops at academic events (where appropriate)

d) Patient engagement events e.g. open lectures and talks (http://www.engagement.manchester.ac.uk/about/index.html)

e) Local meetings, held in Greater Manchester, will be attended by clinicians, healthcare practitioners, healthcare scientists, clinical managers, heart failure charities and patients.

3. A lay summary of results for patients and interested non-academic parties disseminated via:

a) Research Webpage for Manchester Heart Centre.

b) Letters/emails to study participants

c) MFT, UoM and other publicly accessible websites (e.g. Medtronic)

d) Results may be disseminated in the form of progress reports for interested parties

The target time for release of these outputs is October 2023.

MFT has a research collaboration agreement in place with Medtronic outlining data and knowledge ownership and access rights. Results will be shared with all stakeholders (including Medtronic) but Medtronic will only see aggregated outputs of the NHS Digital data with small number suppression. Stakeholders will have no influence on the evaluation results.

Benefits reported

Yielded Benefits is not a requirement for new applications.

Register history

When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds, the earliest of which is July 2021.

July 2021 — already listed in the earliest edition this site holds, so it may be older.
1 version: DARS-NIC-401890-W6Q8W-v0.14
November 2022
1 version added: DARS-NIC-401890-W6Q8W-v1.6
July 2024
1 version added: DARS-NIC-401890-W6Q8W-v2.7
July 2026
1 version added: DARS-NIC-401890-W6Q8W-v3.7

Cite this page

NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-401890-W6Q8W, “Prospective Triage HF+ Evaluation: What is the workload burden associated with using the Triage HF+ care pathway?”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-401890-w6q8w/ (accessed [date]).

This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.

Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-401890-W6Q8W to see the original rows.