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

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ClinicalTrials.gov Identifier: NCT04177199
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Medtronic
Pennine Acute Hospitals NHS Trust
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Tracking Information
First Submitted Date September 5, 2019
First Posted Date November 26, 2019
Last Update Posted Date April 8, 2021
Actual Study Start Date September 6, 2019
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 22, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 22, 2019)
  • Number of clinical touchpoints pre-Triage-HF Plus (current state) compared to post-Triage-HF Plus Implementation (future state, prospective). [ Time Frame: Duration of study, expected 18 months ]
    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.
  • Cost of Triage-HF Plus pathway at each site [ 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 the cost of the Triage HF pathway at each site.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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?
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts Not Provided
Publications * 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). pii: e001600. doi: 10.1136/openhrt-2021-001600.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 22, 2019)
750
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sarah Mackie 01612763336 sarah.mackie@mft.nhs.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04177199
Other Study ID Numbers B00454
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Manchester University NHS Foundation Trust
Study Sponsor Manchester University NHS Foundation Trust
Collaborators
  • Medtronic
  • Pennine Acute Hospitals NHS Trust
Investigators Not Provided
PRS Account Manchester University NHS Foundation Trust
Verification Date April 2021