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EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways (EHRA-PATHS)

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EHRA-PATHS software tool
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent) ≥65 years of age Willing and able to participate and to attend the scheduled follow-up visits. Exclusion Criteria: Atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.) Life expectancy of less than 1 year Participation in another clinical study (registry studies not included) Severe cognitive impairment / dementia (defined based on MMSE and CDR scoring systems)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    New care program

    Routine clinical care

    Arm Description

    The health care provider will use the EHRA-PATHS' newly developed care pathways to assess whether there is an indication for presence of risk factors and comorbidities. If this is the case, the care pathways will show possible next steps for confirming the presence of these risk factors and comorbidities. If confirmed, treatment according to the current guidelines should be initiated. Since this leads to an individualized management plan, procedures can differ between patients and will also depend on local processes.

    The health care provider follows current clinical practice with regards to history taking, physical examination etc.

    Outcomes

    Primary Outcome Measures

    Identification and management of risk factors and comorbidities
    The number of risk factors and comorbidities that are identified and for which treatment is initiated during base mapping and at the end of the randomized controlled trial.

    Secondary Outcome Measures

    AF symptom burden
    Measured with the Atrial Fibrillation Severity Scale (AFSS) questionnaire
    Quality of life (QoL)
    Measured with the EuroQol five-dimensional five-level (EQ-5D-5L) questionnaire
    Referrals to other disciplines
    The referrals to other disciplines will consist of the number of referrals and the percentage of patients referred.
    Patient and health care provider satisfaction
    Measured with a patient and health care provider (HCP) satisfaction questionnaire
    Healthcare resource use/costs
    Measured with the iMedical Consumption Questionnaire (iMCQ)
    HRQoL/utility
    Measured with the EQ-5D-5L questionnaire (iMCQ)

    Full Information

    First Posted
    February 15, 2023
    Last Updated
    March 15, 2023
    Sponsor
    University Medical Center Groningen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05773768
    Brief Title
    EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways
    Acronym
    EHRA-PATHS
    Official Title
    EHRA-PATHS: Addressing Multimorbidity in Elderly Atrial Fibrillation Patients Through Interdisciplinary, Patient-centred Systematic Care Pathways - Clinical and Health Economic Evaluation of New Care Pathways
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    January 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Medical Center Groningen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities also affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways. The aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly AF patients, compared to current standard care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    New care program
    Arm Type
    Experimental
    Arm Description
    The health care provider will use the EHRA-PATHS' newly developed care pathways to assess whether there is an indication for presence of risk factors and comorbidities. If this is the case, the care pathways will show possible next steps for confirming the presence of these risk factors and comorbidities. If confirmed, treatment according to the current guidelines should be initiated. Since this leads to an individualized management plan, procedures can differ between patients and will also depend on local processes.
    Arm Title
    Routine clinical care
    Arm Type
    No Intervention
    Arm Description
    The health care provider follows current clinical practice with regards to history taking, physical examination etc.
    Intervention Type
    Device
    Intervention Name(s)
    EHRA-PATHS software tool
    Intervention Description
    Newly developed care pathways integrated into a care-management software tool
    Primary Outcome Measure Information:
    Title
    Identification and management of risk factors and comorbidities
    Description
    The number of risk factors and comorbidities that are identified and for which treatment is initiated during base mapping and at the end of the randomized controlled trial.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    AF symptom burden
    Description
    Measured with the Atrial Fibrillation Severity Scale (AFSS) questionnaire
    Time Frame
    6 months
    Title
    Quality of life (QoL)
    Description
    Measured with the EuroQol five-dimensional five-level (EQ-5D-5L) questionnaire
    Time Frame
    6 months
    Title
    Referrals to other disciplines
    Description
    The referrals to other disciplines will consist of the number of referrals and the percentage of patients referred.
    Time Frame
    6 months
    Title
    Patient and health care provider satisfaction
    Description
    Measured with a patient and health care provider (HCP) satisfaction questionnaire
    Time Frame
    6 months
    Title
    Healthcare resource use/costs
    Description
    Measured with the iMedical Consumption Questionnaire (iMCQ)
    Time Frame
    6 months
    Title
    HRQoL/utility
    Description
    Measured with the EQ-5D-5L questionnaire (iMCQ)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent) ≥65 years of age Willing and able to participate and to attend the scheduled follow-up visits. Exclusion Criteria: Atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.) Life expectancy of less than 1 year Participation in another clinical study (registry studies not included) Severe cognitive impairment / dementia (defined based on MMSE and CDR scoring systems)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways

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