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

Heart Failure Clinical Trial

— TRIAGE-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04177199
• Other study ID #: B00454
• Status: Recruiting
• Start date: September 6, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2023
• Source: Manchester University NHS Foundation Trust
• Contact: Sarah Mackie
• Phone: 01612763336
• Email: sarah.mackie[@]mft.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Manchester Royal Infirmary, Manchester University NHS Foundation Trust	Manchester
United Kingdom	Wythenshawe Hospital, Manchester University NHS Foundation Trust	Manchester
United Kingdom	Pennine Acute Hospitals NHS Foundation Trust, Royal Oldham Hospital	Oldham	Lancashire

Sponsors (3)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	Medtronic, Pennine Acute Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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