Pharmacy-based Opportunistic Atrial Fibrillation Screening Integrated With Emergency Services (NUMAPLUS-FA)
Condition(s) studied
Investigational drug(s) / intervention(s)
Integrated pharmacy-based AF screening circuit: A coordinated opportunistic screening model integrating community pharmacies, emergency medical services (Salud Responde, CES 061) and primary care physicians. The model comprises: opportunistic patient identification during routine pharmacy visits; 30-second ECG recording using the Kardias 6-lead portable device; real-time data transmission via the Numaplus platform; structured clinical triage by Salud Responde nursing staff; and referral to primary care for definitive diagnosis and treatment. Implementation strategies include a structured EASP-accredited online training programme, ongoing technical support, activity feedback reports and a performance-based financial incentive of 20 euros per complete valid case.
Study summary
This study evaluates the feasibility and fidelity of an opportunistic atrial fibrillation (AF) screening programme conducted in 38 community pharmacies in Seville (Spain), using the Kardias® 6-lead portable ECG device, coordinated with the emergency medical services centre Salud Responde (CES 061) and primary care physicians. Eligible participants are individuals aged 65 years or older without a prior AF diagnosis who attend a participating pharmacy for any routine purpose. The screening consists of a 30-second ECG recording performed by a trained community pharmacist. Positive or indeterminate results are transmitted in real time to Salud Responde for clinical validation and referral to primary care. The study is evaluated using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The primary outcome is protocol fidelity, measured by the Implementation Adherence Grade (IAG). The study is part of the NUMAPLUS project, funded by INTERREG VI-A España-Portugal (POCTEP 2021-2027), co-financed by the European Regional Development Fund (ERDF).
Eligibility
Primary outcome measure(s)
- Implementation Adherence Grade (IAG) — Through study completion, an average of 6 months
Implementation Adherence Grade (IAG) Composite fidelity index expressed as the percentage of mandatory protocol items completed per screening case, calculated as (number of mandatory items completed / 5) × 100. The five mandatory items, each scored dichotomously as completed (1) or not completed (0) and weighted equally, are: (1) written informed consent obtained and documented; (2) minimum demographic data recorded; (3) complete CHA₂DS₂-VA score calculated; (4) successful 30-second ECG tracing obtained within a maximum of three attempts; and (5) documented contact with Salud Responde for all cases classified as suspected or indeterminate atrial fibrillation. The pharmacy-level and study-level IAG is the mean of individual case-level IAG values. Target value: ≥90%. Unit of Measure: Percentage of mandatory protocol items completed (single composite index).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Centro de Emergencias Sanitarias 061 | Seville | SEVILLA |
More Centro de Emergencias Sanitarias 061 Andalucía trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07598903 on ClinicalTrials.gov ↗ ← All trials in Spain