Solutions for Atrial Fibrillation Edvocacy (SAFE) (SAFE)

Solutions for Atrial Fibrillation Edvocacy (SAFE) Improving Awareness and Access to Atrial Fibrillation Screening for Detection and Referral for Treatment

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Atrial Fibrillation; Cardiac Arrhythmia
• Intervention / Treatment: Device: Screening, detection and referral for atrial fibrillation

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 Type: Observational
• Enrollment (Actual): 650

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Central Study Sponsor Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals who are at least 18 years of age who does not have a pacemaker or implantable cardioverter defibrillator (ICD) or other implanted electronic devices, is not pregnant, is not lacking capacity, and presenting to a pharmacist for usual and customary care.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational Cohort; Screening, detection, and referral for atrial fibrillation	Device: Screening, detection and referral for atrial fibrillation; In-pharmacy cardiovascular risk assessment plus AliveCor KardiaMobile reading

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: American Pharmacists Association Foundation
• Investigators: Principal Investigator: Benjamin M Bluml, Pharmacy, American Pharmacists Association Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 021

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