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

NHS Foundation Trust

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: TRIAGE HF Pathway

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04177199

B00454

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.