What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?

NCT04177199 | Unknown

• 1 other identifier: B00454
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 3

Brief Summary

This observational, prospective real-world evaluation will estimate and characterize the heart-failure related clinical workload burden associated with implementing a new care pathway (Triage-HF Plus) for remote monitoring and management in a cohort of device patients at 3 hospital sites in North West England as compared to the heart-failure related clinical workload burden prior to using this new care pathway. Triage-HF Plus incorporates the Triage-HF algorithm which is a device-based algorithm that uses the input from the integrated device diagnostics to detect changes in physiological parameters which may indicate an individual's increased risk of heart failure event in the 30 days after a high Triage-HF score.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Number of clinical touchpoints will be used to calculate clinical workload burden

  The workload burden associated with using the Triage HF+ care pathway as compared to the heart failure-related clinic burden prior to using the Triage HF+ care pathway will be calculated using clinical touchpoints including number of hospitalisations, number of A\&E/ MAU visits, number of outpatient appointments, number of remote scheduled device follow ups, and number of telephone contacts.

  Duration of study, expected 18 months

• Time for completing clinical touchpoints will be used to calculate clinical workload burden

  Estimated time for completing clinical touchpoint activities will be calculated from established NHS guidelines/ standards and used to calculate clinical workload burden.

  Duration of study, expected 18 months

Secondary Outcomes (2)

• Number of clinical touchpoints pre-Triage-HF Plus (current state) compared to post-Triage-HF Plus Implementation (future state, prospective).

  Duration of study, expected 18 months

• Cost of Triage-HF Plus pathway at each site

  Duration of study, expected 18 months

Interventions

TRIAGE HF Pathway OTHER

A new care pathway (Triage-HF Plus) for the remote monitoring and management of heart failure stability in a cohort of device patients at 3 hospital sites in North West England.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged \> 18 years with Medtronic CareLink® and Triage-HF compatible cardiac device in situ undergoing remote monitoring.

You may qualify if:

• Patient implanted with a Medtronic ICD, CRT-D, or CRT-P device that is Triage-HF compatible and capable of automated transmission. Note: Remote monitoring data will not be available for 60 days post a new or replacement implant but patients can be enrolled in the evaluation any time after implant.
• Patient (or patient's legally authorized representative) is willing and able to provide written informed consent.
• Patients with CareAlerts already turned ON will be included in the prospective part of the evaluation but their data may be excluded from the pre-Triage-HF Plus (current state) data analysis.
• Patients willing and able to have CareLink monitor active at all times.

You may not qualify if:

• Patient is enrolled in another conflicting evaluation/study that could confound the results of this evaluation by increasing clinic workload burden for that patient and/or impact clinical interventions and patient outcomes
• All patients with non-Triage-HF compatible devices
• All patients with devices that require manual transmission (non-automated)
• Patient is unwilling or unable to comply with the protocol, including follow-up visits and CareLink transmissions.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Medtronic: collaborator
• Pennine Acute Hospitals NHS Trust: collaborator

Study Sites (3)

Pennine Acute Hospitals NHS Foundation Trust, Royal Oldham Hospital

Oldham, Lancashire, OL1 2JH, United Kingdom

NOT YET RECRUITING

Manchester Royal Infirmary, Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

Wythenshawe Hospital, Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

NOT YET RECRUITING

Related Publications (2)

• Ahmed FZ, Harwood R, Lanctin D, Leonard C, Medland S, Afonso D, Mealing S, Weldon T, Blunt C, Campbell NG, Taylor JK. Economic evaluation of the TriageHF Plus clinical pathway for device-based remote monitoring in heart failure. Heart. 2025 Dec 17:heartjnl-2025-326702. doi: 10.1136/heartjnl-2025-326702. Online ahead of print.

  PMID: 41407535 DERIVED

• Taylor JK, Ndiaye H, Daniels M, Ahmed F; Triage-HF Plus investigators. Lockdown, slow down: impact of the COVID-19 pandemic on physical activity-an observational study. Open Heart. 2021 Jun;8(1):e001600. doi: 10.1136/openhrt-2021-001600.

  PMID: 34088789 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Sarah Mackie

CONTACT

01612763336; sarah.mackie@mft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: November 26, 2019
• Study Start: September 6, 2019
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

GB (3)