Evaluating the workload burden of a new heart failure care pathway
Prospective Triage HF+ Evaluation: What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
This study is trying to see how a new heart failure care plan affects the amount of work for doctors and nurses who help patients using special devices that monitor their health from home.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust Government |
| Locations | 3 sites (Oldham, Lancashire and 2 other locations) |
| Trial ID | NCT04177199 on ClinicalTrials.gov |
What this trial studies
This observational evaluation aims to estimate and characterize the clinical workload burden associated with the Triage HF+ care pathway for remote monitoring and management of heart failure patients. The study will compare the workload burden before and after implementing this new care pathway in a cohort of patients with compatible devices across three hospital sites in North West England. The Triage-HF algorithm will be utilized to detect changes in physiological parameters that may indicate an increased risk of heart failure events. The evaluation will involve patients implanted with specific Medtronic devices capable of automated data transmission.
Who should consider this trial
Good fit: Ideal candidates are patients implanted with a Medtronic ICD, CRT-D, or CRT-P device that is compatible with the Triage-HF algorithm.
Not a fit: Patients enrolled in conflicting evaluations or those with non-Triage-HF compatible devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of heart failure patients through more efficient monitoring and reduced clinical workload.
How similar studies have performed: While this approach is innovative, similar studies evaluating remote monitoring in heart failure have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oldham, Lancashire and 2 other locations
- Pennine Acute Hospitals NHS Foundation Trust, Royal Oldham Hospital — Oldham, Lancashire, United Kingdom (Not_yet_recruiting)
- Manchester Royal Infirmary, Manchester University NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
- Wythenshawe Hospital, Manchester University NHS Foundation Trust — Manchester, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Sarah Mackie
- Email: sarah.mackie@mft.nhs.uk
- Phone: 01612763336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.