Solutions for Atrial Fibrillation Edvocacy (SAFE)

Completed

• Conditions: Cardiac Arrhythmia; Cardiovascular Diseases; Atrial Fibrillation
• Interventions: Device: Screening, detection and referral for atrial fibrillation

• Registration Number: NCT05067114
• Lead Sponsor: American Pharmacists Association Foundation

Brief Summary

The aim of this demonstration project is to create an additional access point in the community at local pharmacies for atrial fibrillation screening, detection, and referral to physicians for follow-up and initiation of evidence-based therapy when appropriate.

Detailed Description

The APhA Foundation will implement the Solutions for Atrial Fibrillation Edvocacy (SAFE) demonstration project integrating atrial fibrillation (Afib) screening, detection, and referral services as a routine component of care in community-based pharmacies. The SAFE solution is designed to improve awareness about Afib, increase access to screening and education opportunities related to Afib, and offer a team-based approach to care that will ultimately improve public health outcomes.

This multi-site study will utilize community pharmacies to identify patients at-risk for Afib through point-of-care patient encounters, proactive patient profile reviews, risk assessment tools, and AliveCor's FDA-cleared EKG technology.

As part of their usual and customary care, pharmacists can identify patients potentially at-risk for Afib through routine patient encounters, proactive patient profile reviews, and subsequent discussions with the patient. Identified patients will then be asked to complete a stroke risk assessment which will help determine the patient's risk level. The pharmacist will utilize the results from the stroke risk assessment to educate the patient on why these factors could add risk, why it's important to monitor these factors, and how the patient can work to reduce or improve upon certain modifiable risk factors. All patients will be educated about the risks of Afib and the importance of future monitoring based on their risk level.

Patients will then be offered the opportunity to utilize the AliveCor EKG technology to capture an EKG reading at the point-of-care. This FDA-cleared device is easy for patients to use and a pharmacy team member will be available to guide the patient to ensure proper use. Patients who are identified as having an abnormal heart rhythm, based on their EKG reading, will be referred to their physician for evaluation and follow-up. Pharmacists will follow-up with the patients that were referred to the physician to facilitate the transition of care and inquire about confirmation of Afib and initiation of treatment. Coordination and communication among patients, pharmacists, and physicians is the foundation of this patient-centered team-based care approach.

Study Timeline

• Study Start: 2021-09-03
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-05
• Primary Completion: 2022-05-31
• Study Completion: 2022-06-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• Any person at least 18 years of age
• Person who is able to present to a pharmacist for usual and customary care

Exclusion Criteria

• Persons who are pregnant
• Persons who are lacking in capacity
• Persons who have a pacemaker or implantable cardioverter defibrillator (ICD) or other implanted electronic devices

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Cohort	Screening, detection and referral for atrial fibrillation	Screening, detection, and referral for atrial fibrillation

Primary Outcome Measures

Name	Time	Method
Completion of atrial fibrillation screenings by pharmacists	September through December 2021	Number of Afib screening tests performed in the pharmacy
Abnormal rhythm detections identified by pharmacists	September through December 2021	Number of abnormal rhythm detections identified by AliveCor KardiaMobile technology
Physician referrals made by pharmacists	September through December 2021	Number of physician follow-up referrals made by the pharmacist

Trial Locations

Locations (1)

Central Study Sponsor Facility; 🇺🇸 Washington, District of Columbia, United States