Pharmacy-based Opportunistic Atrial Fibrillation Screening Integrated With Emergency Services (NUMAPLUS-FA) (Numaplus_FA)

Pharmacy-based Opportunistic Screening for Atrial Fibrillation Using a Portable ECG Device Integrated With Emergency Medical Services: a Prospective Type-1 Hybrid Implementation Study (NUMAPLUS Project)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Mass Screening; Arrythmia, Cardiac; Pharmacies; Atrial Fibrillation (Prevention of Stroke)
• Intervention / Treatment: Other: Integrated pharmacy-based AF screening circuit

Detailed Description

STUDY DESIGN This is a prospective, single-cohort, type-1 effectiveness-implementation hybrid study conducted within the NUMAPLUS project (INTERREG VI-A España-Portugal, POCTEP 2021-2027, co-financed by the European Regional Development Fund). This design was selected because external evidence on the diagnostic accuracy of the Kardias® device is sufficient to justify its deployment, while uncertainty persists regarding the organisational conditions, care pathways and economic incentives required for its sustainable integration into the Andalusian community pharmacy network. The primary focus is on implementation outcomes; clinical outcomes related to atrial fibrillation screening are collected as secondary endpoints. The study is reported in accordance with the Standards for Reporting Implementation Studies (StaRI) guideline.

SETTING The study is conducted in 38 community pharmacies in the province of Seville affiliated with the Real e Ilustre Colegio Oficial de Farmacéuticos de Sevilla (RICOFS), selected by voluntary participation following an open invitation. Eligibility criteria for pharmacies required stable internet connectivity for access to the Numaplus application, completion of pre-study training, and absence of concurrent participation in another cardiovascular screening programme. Priority was given to pharmacies with 24-hour or 12-hour opening schedules. Geographic coverage targets at least three urban health zones per province and at least one semi-urban or rural zone per healthcare management area.

The study articulates three coordination levels: (1) the community pharmacy as the point of patient recruitment and screening; (2) Salud Responde (CES 061) as the clinical validation, risk stratification and real-time coordination node; and (3) the primary care physician as the responsible party for definitive diagnosis and initiation of treatment.

TRAINING OF PARTICIPATING PHARMACISTS Prior to the recruitment period, all enrolled pharmacists completed a structured training programme accredited by the Escuela Andaluza de Salud Pública (EASP) and the Agencia de Calidad Sanitaria de Andalucía (ACSA). The programme was delivered entirely online in asynchronous modality between 23 March and 13 April 2026 (10 hours total) through the EASP Moodle platform. It comprised four learning units: (1) epidemiological basis and scientific rationale for opportunistic AF screening; (2) detection protocol, radial pulse palpation technique, and interpretation of Kardias® device outputs; (3) data entry in the Numaplus platform, risk classification and patient communication within the pharmacy-Salud Responde circuit; and (4) ethical and legal framework, informed consent procedures, and data protection requirements. Certification required completion of all practical activities and a minimum score of 7 out of 10 on the final knowledge assessment.

INTERVENTION

The screening protocol comprises five sequential operational phases aligned with the RE-AIM framework:

Phase 1 (Reach): Opportunistic invitation during dispensing or consultation, without prior appointment. The pharmacist records the monthly denominator of unique patients aged 65 years or older using pharmacy management software. Reasons for refusal are recorded anonymously.

Phase 2 (Adoption): Following written informed consent, the case is opened in the Numaplus application. The pharmacist records current symptoms (palpitations, chest pain, dyspnoea, syncope), oral anticoagulant therapy status, and the CHA₂DS₂-VA score (0-6), adopted per the 2024 ESC Guidelines for AF Management in replacement of CHA₂DS₂-VASc.

Phase 3 (Implementation): The Kardias® 6-lead portable device is applied for a 30-second ECG recording (maximum 3 attempts). The device algorithm classifies the result as: Suspected AF / Sinus rhythm / Bradycardia / Tachycardia / Unclassified. Protocol fidelity is operationalised through the Implementation Adherence Grade (IAG). A performance-based financial incentive of 20 euros per complete and valid case is applied.

Phase 4 (Effectiveness): In case of suspected or indeterminate AF, the Numaplus platform automatically transmits a PDF containing the ECG tracing and clinical data to Salud Responde; simultaneously, the pharmacist places a direct call. The Salud Responde nurse applies a structured triage protocol: emergency 061 activation (heart rate >110 or <60 bpm or alarm symptoms), medium priority referral (haemodynamically stable suspected AF, primary care appointment within 72 hours), or low priority referral (unclassified tracing, scheduled ECG at primary care). Definitive AF diagnosis is confirmed by the primary care physician.

Phase 5 (Maintenance): Six-month telephone follow-up conducted by Salud Responde, assessing anticoagulation initiation and adherence, health-related quality of life (visual analogue scale 0-10), and major adverse events (ischaemic stroke, major bleeding, death).

STATISTICAL ANALYSIS The primary analysis is precision-based, targeting 385 participants (operational target: 380, 10 per pharmacy). Categorical variables are reported as proportions with 95% confidence intervals (Clopper-Pearson); the IAG is estimated with an exact binomial 95% CI. Factors associated with low fidelity are explored by logistic regression. Missing data are handled by multiple imputation (MICE, 20 imputations) if below 15% under the MAR assumption. All analyses are conducted in R version 4.3 or higher.

• Study Type: Interventional
• Enrollment (Estimated): 380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María José ML Luque-Hernández, MD, PhD; Phone Number: +34683511613; Email: mariajose.luque.sspa@juntadeandalucia.es
• Study Contact Backup: Name: Jesús Antonio JC Carrillo-Castrillo, PhD; Phone Number: +34 955006300; Email: jesus.carrillo.castrillo@juntadeandalucia.es

Study Locations

• Spain
  • SEVILLA
    • Seville, SEVILLA, Spain, 41092
      • Centro de Emergencias Sanitarias 061
      • Contact: María José Luque-Hernández, MD, PhD; Phone Number: 683511613; Email: mariajose.luque.sspa@juntadeandalucia.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Study Population

Adults aged 65 years or older attending community pharmacies in the province of Seville (Spain) affiliated with the Real e Ilustre Colegio Oficial de Farmaceuticos de Sevilla (RICOFS). Participation was offered to all community pharmacies in the province through an open invitation via RICOFS; 38 pharmacies meeting eligibility criteria volunteered to participate. Pharmacies are distributed across urban, semi-urban and rural health zones of the Seville healthcare management area.

Description

Inclusion Criteria:

1. Age 65 years or older
2. Attending a participating community pharmacy for any routine healthcare purpose
3. No prior documented or patient-reported diagnosis of atrial fibrillation
4. Capacity to provide written informed consent

Exclusion Criteria:

1. Confirmed prior diagnosis of atrial fibrillation
2. Implanted pacemaker, implantable cardioverter-defibrillator (ICD) or other intracardiac device
3. Clinically evident haemodynamic instability requiring direct emergency 061 activation (active chest pain, severe dyspnoea, syncope)
4. Concurrent participation in another cardiac rhythm monitoring study
5. Inability to maintain the required position for a 30-second ECG recording

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pharmacy-based AF screening cohort; Adults aged 65 years or older attending participating community pharmacies in Seville without prior diagnosis of atrial fibrillation, recruited opportunistically during routine pharmacy visits.

Other: 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.; Other Names: Numaplus digital platform; Salud Responde CES 061; Kardias 6-lead portable ECG device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation Adherence Grade (IAG)	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).	Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation rate (Reach)	Proportion of patients aged 65 years or older who accept screening divided by the monthly denominator of unique patients aged 65 years or older attending each pharmacy.	Monthly, through study completion, an average of 6 months
Pharmacy-level adoption rate	Number of pharmacies completing at least one valid screening divided by the number of invited pharmacies.	At end of recruitment period (month 6)
Acceptability of Intervention Measure (AIM) score	Mean score of the 4-item AIM scale (range 1-5) measuring pharmacist acceptability of the screening programme.	At end of recruitment period (month 6)
Feasibility of Intervention Measure (FIM) score	Mean score of the 4-item FIM scale (range 1-5) measuring pharmacist-perceived feasibility of the screening programme.	At end of recruitment period (month 6)
Suspected AF detection rate.	Proportion of screened participants with Suspected AF classification by the Kardias device algorithm.	Through study completion, an average of 6 months
Confirmed AF diagnosis rate.	Proportion of screened participants with confirmed AF diagnosis following primary care assessment.	Through study completion, an average of 6 months
Linkage to Care rate	Proportion of participants with suspected or indeterminate AF who attend primary care appointment within the planned timeframe.	Up to 72 hours after positive or indeterminate screening result
Oral anticoagulation initiation rate	proportion of participants with confirmed AF initiated on oral anticoagulation.	Up to 6 months after confirmed AF diagnosis
Major adverse events at 6 months	Incidence of ischaemic stroke, major bleeding and death among participants with confirmed AF at 6-month follow-up.	6 months after confirmed AF diagnosis
Refusal rate and reasons	proportion of eligible patients who decline screening, with the main reason for refusal recorded anonymously.	Monthly, through study completion, an average of 6 months
Programme sustainability intention	Proportion of pharmacists reporting intention to continue the screening programme beyond project funding period, assessed through the sustainability block of the post-study questionnaire.	At end of recruitment period (month 6)
Salud Responde coordination performance	Operational indicators of the Salud Responde (CES 061) triage node, including median time from ECG transmission to clinical validation, distribution of triage decisions (emergency 061 activation, medium priority referral, low priority referral), and qualitative assessment of circuit barriers by the SR coordination team at end of study.	Through study completion, an average of 6 months
13a. Salud Responde Coordination. ECG transmission.	Median time from ECG transmission to Salud Responde clinical validation (minutes)	Through study completion, an average of 6 months
Salud Responde coordination. Triage decission	Distribution of Salud Responde triage decisions (percentage of cases in each category: emergency 061 activation / medium priority / low priority)	Through study completion, an average of 6 months
SR circuit barrers	Qualitative assessment of circuit barriers by Salud Responde coordination team (thematic categories)	At end of study (month 6)

Collaborators and Investigators

• Sponsor: Centro de Emergencias Sanitarias 061 Andalucía
• Collaborators: Andaluz Health Service; University of Seville; Andalusian School of Public Health; Andalusian Regional Ministry of Health; Real e Ilustre Colegio Oficial de Farmacéuticos de Sevilla

Publications and helpful links

General Publications

• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
• Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.
• Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, Rycroft-Malone J, Meissner P, Murray E, Patel A, Sheikh A, Taylor SJ; StaRI Group. Standards for Reporting Implementation Studies (StaRI) Statement. BMJ. 2017 Mar 6;356:i6795. doi: 10.1136/bmj.i6795.
• Wahab A, Nadarajah R, Larvin H, Farooq M, Raveendra K, Haris M, Nadeem U, Joseph T, Bhatty A, Wilkinson C, Khunti K, Vedanthan R, Camm AJ, Svennberg E, Lip GY, Freedman B, Wu J, Gale CP. Systematic screening for atrial fibrillation with non-invasive devices: a systematic review and meta-analysis. Lancet Reg Health Eur. 2025 Apr 11;53:101298. doi: 10.1016/j.lanepe.2025.101298. eCollection 2025 Jun.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: atrial fibrillation; community pharmacy; implementation science; emergency medical services; RE-AIM; opportunistic screening; portable ECG; hybrid implementation study
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 0237_NUMAPLUS_5_E_CASE2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data are pseudonymised and collected within the Andalusian Public Health System (SSPA). Data are subject to Spanish data protection legislation (Organic Law 3/2018, LOPD-GDD) and EU GDPR 2016/679 and cannot be made publicly available. Anonymised aggregate data supporting the conclusions of this study may be available upon reasonable request to the corresponding author, subject to institutional approval by the Centro de Emergencias Sanitarias 061 and the Comite Coordinador de Etica de la Investigacion Biomedica de Andalucia (CCEIBA).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No