Cardiovascular DiseasesSAFENCT05067114
Solutions for Atrial Fibrillation Edvocacy (SAFE)
An observational study of Cardiovascular Diseases and Cardiac Arrhythmia, run by American Pharmacists Association Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cardiac Arrhythmia, Atrial Fibrillation
- What is being tested?
- Screening, detection and referral for atrial fibrillation
- Type of treatment
- Medical device
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Any person at least 18 years of age
- Person who is able to present to a pharmacist for usual and customary care
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Study Sponsor Facility
Washington D.C., District of Columbia, 20037
About this study
Official title: 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.
Read the 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.
- Being tested
- Screening, detection and referral for atrial fibrillation
- Medical subject headings
- Cardiovascular Diseases, Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening, detection and referral for atrial fibrillationDevice
In-pharmacy cardiovascular risk assessment plus AliveCor KardiaMobile reading
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | Screening, detection, and referral for atrial fibrillation Receives: Device: Screening, detection and referral for atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of atrial fibrillation screenings by pharmacists
Number of Afib screening tests performed in the pharmacy
Measured: September through December 2021
Abnormal rhythm detections identified by pharmacists
Number of abnormal rhythm detections identified by AliveCor KardiaMobile technology
Measured: September through December 2021
Physician referrals made by pharmacists
Number of physician follow-up referrals made by the pharmacist
Measured: September through December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start3 Sep 2021
- Primary completion31 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Pharmacists Association Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin M Bluml, Pharmacy, Principal investigator, American Pharmacists Association Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067114
- Sponsor's protocol ID
- 021
- Acronym
- SAFE
- Status last verified
- Feb 2023
- First submitted
- 23 Sep 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solutions for Atrial Fibrillation Edvocacy (SAFE) Improving Awareness and Access to Atrial Fibrillation Screening for Detection and Referral for Treatment
- ClinicalTrials.gov ID
- NCT05067114
- Acronym / sponsor ID
- SAFE / 021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- American Pharmacists Association FoundationUniversity, hospital or other
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | Device: Screening, detection and referral for atrial fibrillationScreening, detection, and referral for atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Any person at least 18 years of age
- Person who is able to present to a pharmacist for usual and customary care
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening, detection and referral for atrial fibrillationIn-pharmacy cardiovascular risk assessment plus AliveCor KardiaMobile reading | Device | Observational Cohort |
Primary outcome
Completion of atrial fibrillation screenings by pharmacists
Time frame: September through December 2021
Number of Afib screening tests performed in the pharmacy
Abnormal rhythm detections identified by pharmacists
Time frame: September through December 2021
Number of abnormal rhythm detections identified by AliveCor KardiaMobile technology
Physician referrals made by pharmacists
Time frame: September through December 2021
Number of physician follow-up referrals made by the pharmacist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin M Bluml, Pharmacy principal investigator
American Pharmacists Association Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiac Arrhythmia, run by American Pharmacists Association Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of atrial fibrillation screenings by pharmacists (time frame: September through December 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.