Promoting Atrial Fibrillation Screening in Primary Care

June 10, 2024 updated by: Xi Cao, Sun Yat-sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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 ).

Study Type

Interventional

Enrollment (Estimated)

4800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The intervention group will receive SEARCH-AF intervention which includes opportunistic screening and screening promoting strategies.
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.
Active Comparator: Control group
All the control groups will finally receive the SEARCH-AF 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation detection rate
Time Frame: End of the intervention (T0), three-month (T1) and six-month (T2) after the intervention.
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

Outcome Measure
Measure Description
Time Frame
Anticoagulation rate
Time Frame: Three-month and six-month post the intervention
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
Time Frame: Six-month post the intervention
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
Time Frame: Three-month and six-month post the intervention
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
Time Frame: Three-month and six-month post the intervention
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
Time Frame: Three-month and six-month post the intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xi CAO, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sunyatsenu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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