Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05067114 |
| Other study ID # |
021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
