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

March 14, 2023 updated by: Manchester University NHS Foundation Trust

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Manchester Royal Infirmary, Manchester University NHS Foundation Trust
        • Contact:
      • Manchester, United Kingdom, M13 9WL
        • Not yet recruiting
        • Wythenshawe Hospital, Manchester University NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Paul Callan
        • Principal Investigator:
          • Niall Campbell
    • Lancashire
      • Oldham, Lancashire, United Kingdom, OL1 2JH
        • Not yet recruiting
        • Pennine Acute Hospitals NHS Foundation Trust, Royal Oldham Hospital
        • Contact:
        • Principal Investigator:
          • Matthew Kahn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Duration of study, expected 18 months
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.
Duration of study, expected 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Duration of study, expected 18 months
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.
Duration of study, expected 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Manchester University NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic
Pennine Acute Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B00454

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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