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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Triage HF+ Evaluation: What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?

Conditions
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Heart Failure

Intervention / Treatment
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* Other: TRIAGE HF Pathway


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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). | 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 | 
| Cost of Triage-HF Plus pathway at each site | 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 |