Promoting Atrial Fibrillation Screening in Primary Care
NCT Number: NCT06458829
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation New Onset
Interventions: BEHAVIORAL: SEARCH-AF
Sponsor: Sun Yat-sen University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 4800
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-07-01
Completion Date: 2026-12-30

Summary:
Atrial fibrillation is the most common sustained cardiac arrhythmia in adults. Due to the asymptomatic and paroxysmal nature (randomly and shortly occurring of atrial fibrillation, and can therefore remain unnoticed) of atrial fibrillation. Atrial fibrillation increases the risk of stroke five fold if left untreated.

Screening in old populations above age 65 years is helpful to find more atrial fibrillation cases. However, screening for atrial fibrillation is not well implemented in China. Thus, this project aims to promote atrial fibrillation screening in primary care centers in China. We will develop an intervention program (SEARCH-AF) and examine the effects (including the clinical effects and implementation effects) of program.

Primary Outcome Measures: Atrial fibrillation detection rate, Rate of newly detected atrial fibrillation. The data will be collected via medical records (primary care medical system) review and patient interview., End of the intervention (T0), three-month (T1) and six-month (T2) after the intervention.
Secondary Outcome Measures: Anticoagulation rate, Anticoagulation rate among the newly detected atrial fibrillation cases. The data will be collected via medical records (primary care medical system) review and patient interview., Three-month and six-month post the intervention|Cost-effectiveness, Cost-effectiveness refers to the cost of screening for one atrial fibrillation and preventing for one stroke, respectively. It will be assessed using cost-effectiveness ratio. The cost of intervention will include the direct screening cost (screening tool, manpower for carrying out the screening, training on screening, leaflet etc), cost on anticoagulation (expense on oral anticoagulants) and stroke treatment (in-hospital and out-of-hospital cost on stroke treatment). The cost of control group will include the cost on anticoagulation(expense on oral anticoagulants) and stroke treatment (in-hospital and out-of-hospital cost on stroke treatment ). All the cost data will be collected using a patient-reported information sheet., Six-month post the intervention|Atrial fibrillation associated events, Including stroke, bleeding events associated with anticoagulation (referred to bleeding that requires in-hospital treatment), and death. The data will be collected via medical records (primary care medical system) and patient interview., Three-month and six-month post the intervention|Atrial fibrillation related medical resource consumption, Including the number of in-hospital and out-of-hospital visits due to atrial fibrillation. Such data will be collected using a patient-reported information sheet., Three-month and six-month post the intervention|Compliance with atrial fibrillation screening, Compliance with atrial fibrillation screening refers to the degree of general practitioner/nurse perform screening as requested during the follow-up. It will be calculated by the number of practitioners/nurses who remained in the screening during follow-up/ the initial number of practitioner/nurse performing the screening. Such data will be collected using a practitioner/nurse-reported information sheet., Three-month and six-month post the intervention