Skip to main content
OpenTrials
Completed

NCT Number: NCT05067114

Solutions for Atrial Fibrillation Edvocacy (SAFE)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Study Sponsor Facility

Washington D.C., District of Columbia, 20037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening, detection and referral for atrial fibrillation

Device

In-pharmacy cardiovascular risk assessment plus AliveCor KardiaMobile reading

Primary outcomes

  1. Completion of atrial fibrillation screenings by pharmacists

    Time frame: September through December 2021

    Number of Afib screening tests performed in the pharmacy

  2. Abnormal rhythm detections identified by pharmacists

    Time frame: September through December 2021

    Number of abnormal rhythm detections identified by AliveCor KardiaMobile technology

  3. Physician referrals made by pharmacists

    Time frame: September through December 2021

    Number of physician follow-up referrals made by the pharmacist

Sponsors and collaborators

Lead sponsor

American Pharmacists Association Foundation

Other

Registry information

Official study title

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

Acronym: SAFE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2021
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.