Solutions for Atrial Fibrillation Edvocacy (SAFE)

Cardiovascular Diseases Clinical Trial

— SAFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05067114
• Other study ID #: 021
• Status: Completed
• Start date: September 3, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2023
• Source: American Pharmacists Association Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmia
• Cardiovascular Diseases

Intervention

Device:
• Screening, detection and referral for atrial fibrillation
In-pharmacy cardiovascular risk assessment plus AliveCor KardiaMobile reading

Locations

Country	Name	City	State
United States	Central Study Sponsor Facility	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
American Pharmacists Association Foundation

Country where clinical trial is conducted

United States, 

Outcome

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