- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04177199
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway? (TRIAGE-HF)
March 14, 2023 updated by: Manchester University NHS Foundation Trust
Prospective Triage HF+ Evaluation: What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
750
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sarah Mackie
- Phone Number: 01612763336
- Email: sarah.mackie@mft.nhs.uk
Study Locations
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-
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Manchester, United Kingdom, M13 9WL
- Recruiting
- Manchester Royal Infirmary, Manchester University NHS Foundation Trust
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Contact:
- Sarah Mackie
- Phone Number: 01612763336
- Email: sarah.mackie@mft.nhs.uk
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Manchester, United Kingdom, M13 9WL
- Not yet recruiting
- Wythenshawe Hospital, Manchester University NHS Foundation Trust
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Contact:
- Cathy Spence
- Email: cathy.spence@mft.nhs.uk
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Principal Investigator:
- Paul Callan
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Principal Investigator:
- Niall Campbell
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Lancashire
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Oldham, Lancashire, United Kingdom, OL1 2JH
- Not yet recruiting
- Pennine Acute Hospitals NHS Foundation Trust, Royal Oldham Hospital
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Contact:
- Matthew Kahn
- Email: matthew.kahn@pat.nhs.uk
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Principal Investigator:
- Matthew Kahn
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Duration of study, expected 18 months
|
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.
|
Duration of study, expected 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Duration of study, expected 18 months
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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.
|
Duration of study, expected 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2019
Primary Completion (Anticipated)
June 30, 2025
Study Completion (Anticipated)
June 30, 2025
Study Registration Dates
First Submitted
September 5, 2019
First Submitted That Met QC Criteria
November 22, 2019
First Posted (Actual)
November 26, 2019
Study Record Updates
Last Update Posted (Actual)
March 15, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B00454
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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