Prospective Triage HF+ Evaluation: What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Manchester University NHS Foundation Trust
- Enrollment
- 750
- Locations
- 3
- Primary Endpoint
- Time for completing clinical touchpoints will be used to calculate clinical workload burden
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- 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)