Clinical trial NCT04177199: What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Official title: Prospective Triage HF+ Evaluation: What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Medtronic
name: Pennine Acute Hospitals NHS Trust
First posted: 2019-11-26
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Number of clinical touchpoints will be used to calculate clinical workload burden
timeFrame: Duration of study, expected 18 months
measure: Time for completing clinical touchpoints will be used to calculate clinical workload burden
timeFrame: Duration of study, expected 18 months
Secondary outcomes:
measure: Number of clinical touchpoints pre-Triage-HF Plus (current state) compared to post-Triage-HF Plus Implementation (future state, prospective).
timeFrame: Duration of study, expected 18 months
measure: Cost of Triage-HF Plus pathway at each site
timeFrame: Duration of study, expected 18 months
Other outcomes:
Locations:
city: Oldham
country: United Kingdom
facility: Pennine Acute Hospitals NHS Foundation Trust, Royal Oldham Hospital
state: Lancashire
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary, Manchester University NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital, Manchester University NHS Foundation Trust
Study officials:
References:
citation: Taylor JK, Ndiaye H, Daniels M, Ahmed F; Triage-HF Plus investigators. Lockdown, slow down: impact of the COVID-19 pandemic on physical activity-an observational study. Open Heart. 2021 Jun;8(1):e001600. doi: 10.1136/openhrt-2021-001600.