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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: EHRA-PATHS software tool

• Study Type: Interventional
• Enrollment (Estimated): 1300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • Recruiting
    • University Medical Center Groningen
    • Contact: Bart A Mulder, MD/PhD; Phone Number: 0655257399; Email: b.a.mulder@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New care program; 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.	Device: EHRA-PATHS software tool; Newly developed care pathways integrated into a care-management software tool
No Intervention: Routine clinical care; The health care provider follows current clinical practice with regards to history taking, physical examination etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF symptom burden	Measured with the Atrial Fibrillation Severity Scale (AFSS) questionnaire	6 months
Quality of life (QoL)	Measured with the EuroQol five-dimensional five-level (EQ-5D-5L) questionnaire	6 months
Referrals to other disciplines	The referrals to other disciplines will consist of the number of referrals and the percentage of patients referred.	6 months
Patient and health care provider satisfaction	Measured with a patient and health care provider (HCP) satisfaction questionnaire	6 months
Healthcare resource use/costs	Measured with the iMedical Consumption Questionnaire (iMCQ)	6 months
HRQoL/utility	Measured with the EQ-5D-5L questionnaire (iMCQ)	6 months

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: EHRA-PATHS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No