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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773768
• Other study ID #: EHRA-PATHS
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• EHRA-PATHS software tool
Newly developed care pathways integrated into a care-management software tool

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

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