EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EHRA-PATHS software tool.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device EHRA-PATHS software tool
Newly developed care pathways integrated into a care-management software tool
Primary outcome measures
- Identification and management of risk factors and comorbidities [Time frame: 6 months]
Secondary outcome measures (6)
- AF symptom burden [Time frame: 6 months]
- Quality of life (QoL) [Time frame: 6 months]
- Referrals to other disciplines [Time frame: 6 months]
- Patient and health care provider satisfaction [Time frame: 6 months]
- Healthcare resource use/costs [Time frame: 6 months]
- HRQoL/utility [Time frame: 6 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Identifiers
NCT: NCT05773768 · EHRA-PATHS