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What is the Workload Burden Associated With Using the Triage HF+ Care Pathway? (TRIAGE-HF)

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ClinicalTrials.gov Identifier: NCT04177199
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Medtronic
Pennine Acute Hospitals NHS Trust
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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.

Condition or disease Intervention/treatment
Heart Failure Other: TRIAGE HF Pathway

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Triage HF+ Evaluation: What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Actual Study Start Date : September 6, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Other: TRIAGE HF Pathway
    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.


Primary Outcome Measures :
  1. Number of clinical touchpoints will be used to calculate clinical workload burden [ Time Frame: Duration of study, expected 18 months ]
    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.

  2. Time for completing clinical touchpoints will be used to calculate clinical workload burden [ Time Frame: Duration of study, expected 18 months ]
    Estimated time for completing clinical touchpoint activities will be calculated from established NHS guidelines/ standards and used to calculate clinical workload burden.


Secondary Outcome Measures :
  1. Number of clinical touchpoints pre-Triage-HF Plus (current state) compared to post-Triage-HF Plus Implementation (future state, prospective). [ Time Frame: Duration of study, expected 18 months ]
    Secondary, ancillary metrics (descriptive statistics) will be collected to characterize the clinical context pre-Triage-HF Plus (current state) and post-Triage-HF Plus Implementation (future state, prospective) and guide further improvements. Metrics include total number of Triage HF transmissions, total scheduled transmissions, number of low/ medium/high Triage HF risk scores, number of high Triage HF episodes, number of patients with high Triage HF risk scores, and number of hospitalisations.

  2. Cost of Triage-HF Plus pathway at each site [ Time Frame: Duration of study, expected 18 months ]
    Estimated time for completing clinical touchpoint activities will be calculated from established NHS guidelines/ standards and used to calculate the cost of the Triage HF pathway at each site.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04177199


Contacts
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Contact: Sarah Mackie 01612763336 sarah.mackie@mft.nhs.uk

Locations
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United Kingdom
Pennine Acute Hospitals NHS Foundation Trust, Royal Oldham Hospital Not yet recruiting
Oldham, Lancashire, United Kingdom, OL1 2JH
Contact: Matthew Kahn       matthew.kahn@pat.nhs.uk   
Principal Investigator: Matthew Kahn         
Manchester Royal Infirmary, Manchester University NHS Foundation Trust Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Sarah Mackie    01612763336    sarah.mackie@mft.nhs.uk   
Principal Investigator: Fozia Ahmed         
Wythenshawe Hospital, Manchester University NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M13 9WL
Contact: Cathy Spence       cathy.spence@mft.nhs.uk   
Principal Investigator: Paul Callan         
Principal Investigator: Niall Campbell         
Sponsors and Collaborators
Manchester University NHS Foundation Trust
Medtronic
Pennine Acute Hospitals NHS Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04177199    
Other Study ID Numbers: B00454
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases