Promoting Atrial Fibrillation Screening in Primary Care

Atrial Fibrillation New Onset Clinical Trial

Official title:

Effects of an Implementation Program to Promote Atrial Fibrillation Screening in Primary Care Centers in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458829
• Other study ID #: Sunyatsenu
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: June 2024
• Source: Sun Yat-sen University
• Contact: Xi CAO, PhD
• Phone: (86)02084333829
• Email: caox29[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Six health care centers in Guangzhou China will be included. We will adopt a stepped-wedge randomized trial design. Two health care centers will be randomly selected to receive the SEARCH-AF program at each step (a total of three steps). The SEARCH-AF program will include opportunistic screening among those who aged 65 or above and screening promoting strategies. The A total of 4800 old adults will be screened for atrial fibrillation using a handheld single-lead ECG tool upon their visit to family doctor, with 800 for each health care center. The promoting strategy will be developed based on the Consolidated Framework for Implementation Research and include leadership engagement, policy support, providing screening resources, staff training on atrial fibrillation screening and management. The whole study will last for 18 months. We will examine the intervention effects including clinical effects (atrial fibrillation detection rate, anticoagulation rate, atrial fibrillation related hospital visits, and stroke related end points) and implementation effects (cost-effectiveness of the intervention, compliance to atrial fibrillation screening ).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4800
• Est. completion date: December 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• aged 65 years or above
• living in community

Exclusion Criteria:

• with a previous confirmed diagnosis of atrial fibrillation
• with implanted ICD or pacemaker
• unable to provide consent
• involving in other atrial fibrillation screening program

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

Behavioral:
• SEARCH-AF
SEARCH-AF program will include opportunistic screening among old adults during primary care visits and promoting strategies. Promoting strategies will be developed based on the Consolidated Framework for Implementation Research framework which may include leadership engagement, policy support, providing screening resources, atrial fibrillation screening and management training. General practitioner or nurse in each health care center will implement point-on-care screening. The intervention will last for six months and followed up for another six months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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