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

University Medical Center Groningen (UMCG)

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: EHRA-PATHS software tool

Study type: Interventional

Funder types: Other

Identifiers

NCT05773768

EHRA-PATHS

Details and patient eligibility

About

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.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,300 participants in 2 patient groups

New care program

Experimental group

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.

Treatment:

Device: EHRA-PATHS software tool

Routine clinical care

No Intervention group

Description:

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