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

NCT05773768 | Recruiting

• 1 other identifier: EHRA-PATHS
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• AF symptom burden

  6 months

• Quality of life (QoL)

  6 months

• Referrals to other disciplines

  6 months

• Patient and health care provider satisfaction

  6 months

• Healthcare resource use/costs

  6 months

Study Arms (2)

New care program

EXPERIMENTAL

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

Routine clinical care

NO INTERVENTION

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

Interventions

EHRA-PATHS software tool DEVICE

Newly developed care pathways integrated into a care-management software tool

New care program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 17, 2023
• Study Start: March 28, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)