Solutions for Atrial Fibrillation Edvocacy (SAFE)

Sponsor
American Pharmacists Association Foundation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05067114
Collaborator
(none)
2,100
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
2100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Solutions for Atrial Fibrillation Edvocacy (SAFE) Improving Awareness and Access to Atrial Fibrillation Screening for Detection and Referral for Treatment
Anticipated Study Start Date :
Sep 24, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Completion of atrial fibrillation screenings by pharmacists [September through December 2021]

    Number of Afib screening tests performed in the pharmacy

  2. Abnormal rhythm detections identified by pharmacists [September through December 2021]

    Number of abnormal rhythm detections identified by AliveCor KardiaMobile technology

  3. Physician referrals made by pharmacists [September through December 2021]

    Number of physician follow-up referrals made by the pharmacist

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • American Pharmacists Association Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
American Pharmacists Association Foundation
ClinicalTrials.gov Identifier:
NCT05067114
Other Study ID Numbers:
  • 021
First Posted:
Oct 5, 2021
Last Update Posted:
Oct 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2021