Atrial Fibrillation New Onset
Conditions
Brief summary
Shared Decision-Making: AFib 2gether™ is a research study that focuses on a mobile application developed by Pfizer, Inc with consultation from Dr McManus' called AFib 2gether™. Through this app, patients can determine their risk of stroke due to atrial fibrillation and prioritize questions and concerns for discussion with their cardiology provider.
Interventions
DEVICEAfib 2gether TM Mobile Application
The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app.
Sponsors
Pfizer
University of Massachusetts, Worcester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Providers: * Caring for at least 3 patients aged 18 years and older * Have at least 3 patients with International Classification of Diseases tenth revision (ICD-10) diagnostic code consistent with atrial fibrillation (AF) or atrial flutter * Have at least 3 patients with a CHA2DS2-VASc stroke risk score of 2 or more * Have at least 3 patients who are not on anticoagulation * Have at least 3 patients with upcoming appointments within the next 4 months Patients: * Age 18+ * Preferred language is English * Atrial fibrillation diagnosis * Chads vasc score 2 or higher * Not on anticoagulants * No watchman or atrial appendage closure * Had an ambulatory care center (ACC) cardiology appointment in the past 12 months * Future appointment in the next 4 months with the same provider
Exclusion criteria
Providers: * Providers who do not care for at least 3 patients aged 18 years and older * Have patients that do not have an ICD-10 diagnostic code consistent with AF or atrial flutter * Does not have patients with a CHA2DS2-VASc stroke risk score of 2 or more * Their patients are on anticoagulation * Their 3 patients do not have an upcoming visit within the next 4 months Patients: * Under the age of 18; patients * No ICD-10 diagnostic code consistent with AF or atrial flutter * Did not have a visit with a cardiovascular medicine specialist in the previous one year * Patients with a CHA2DS2-VASc score less than 2 * Currently prescribed an anticoagulant * No upcoming cardiology visit in the next 3 months * Has a WATCHMAN device or left atrial appendage closure surgery * On hospice or for whom life expectancy is less than six months and patients * Bleeding episode or fall with injury in the last four weeks * Does not speak English * Prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient MARS Scores | Immediately after visit | Patients evaluated the perceived usefulness of the AFib 2gether mobile application by taking the Mobile App Rating Scale (MARS) questionnaire. This evaluated 3 domains: functionality, aesthetics, and a star-based question. These scores are rated 1-5 with 5 being the highest (best) score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider MARS Scores | Immediately after visit. | Providers were asked to navigate the app features and rate their overall opinion of the mobile app by answering questions using the Mobile App Rating Scale (MARS). This scale evaluates 3 domains: functionality, aesthetics, and a star-based rating question. These scores are rated 1-5 with 5 being the highest (best) score. |
| Reason Why the Patient Was Not on AC Prior to Their Appointment | Immediately after visit | This was an evaluation of why the patient was not on an anticoagulant (AC) prior to their appointment. |
| Afib 2gether Accuracy Assessment | Immediately after visit. | The provider was asked to review the patients stroke risk score on the AFib 2gether app and compare to provider clinical assessment for accuracy. The number of accurate scores were recorded. Ten of the original thirteen providers completed this assessment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Placed on Anticoagulation After Cardiology Appointment | up to 6 months | This outcome measures the number of patient participants with a CHA2DS2-VASc stroke scale score of 2 or higher who are placed on anticoagulation therapy following cardiology appointment. Patients switch to AC will be monitored via the electronic health record. The CHA2DS2-VASc scale is an evaluation of stroke risk for patients with atrial fibrillation. The scale is a composite of 7 questions, with an overall scale score of 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke. |
Countries
United States
Participant flow
Pre-assignment details
We identified 40 patients seeing 13 cardiology providers. Of the 40 patients, 2 were later found ineligible and 1 patient was disenrolled due to provider preference leaving us with 37 patient encounters to analyze. Of the 13 providers, 10 completed the accuracy assessment.
Participants by arm
| Arm | Count |
|---|---|
| AFib 2gether(TM) App Patients with known Atrial Fibrillation will be assigned to download and use an app targeted at determining stroke risk and increasing knowledge of Atrial Fibrillation and stroke risk along with treatment options and will use this information to facilitate a discussion with their cardiovascular provider.
Afib 2gether TM Mobile Application: The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app. | 37 |
| Providers Providers caring for the patients with known Atrial Fibrillation will be asked to review the patients' stroke risk score on the AFib 2gether app and compare to their clinical assessment for accuracy. Baseline measures were not collected for providers. | 0 |
| Total | 37 |
Baseline characteristics
| Characteristic | AFib 2gether(TM) App | Total |
|---|---|---|
| Age, Customized Age: <65 | 6 Participants | 6 Participants |
| Age, Customized Age: 65-74 | 14 Participants | 14 Participants |
| Age, Customized Age: 75+ | 17 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 36 Participants | 36 Participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants |
| Sex: Female, Male Male | 26 Participants | 26 Participants |
| Stroke Risk Score CHA2DS2-VASc score: 2 | 9 Participants | 9 Participants |
| Stroke Risk Score CHA2DS2-VASc score: 3 | 10 Participants | 10 Participants |
| Stroke Risk Score CHA2DS2-VASc score: 4 | 9 Participants | 9 Participants |
| Stroke Risk Score CHA2DS2-VASc score: 5 | 6 Participants | 6 Participants |
| Stroke Risk Score CHA2DS2-VASc score: 6 | 2 Participants | 2 Participants |
| Stroke Risk Score CHA2DS2-VASc score: 7 | 0 Participants | 0 Participants |
| Stroke Risk Score CHA2DS2-VASc score: 8 | 0 Participants | 0 Participants |
| Stroke Risk Score CHA2DS2-VASc score: 9 | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 13 |
| other Total, other adverse events | 0 / 37 | 0 / 13 |
| serious Total, serious adverse events | 0 / 37 | 0 / 13 |
Outcome results
Primary
Patient MARS Scores
Patients evaluated the perceived usefulness of the AFib 2gether mobile application by taking the Mobile App Rating Scale (MARS) questionnaire. This evaluated 3 domains: functionality, aesthetics, and a star-based question. These scores are rated 1-5 with 5 being the highest (best) score.
Time frame: Immediately after visit
Population: Patients with a stroke risk score of 2 or higher and have a diagnosis of AF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient | Patient MARS Scores | Functionality | 4.51 score on a scale | Standard Deviation 0.61 |
| Patient | Patient MARS Scores | Aesthetics | 4.26 score on a scale | Standard Deviation 0.51 |
| Patient | Patient MARS Scores | Star-Based | 4.24 score on a scale | Standard Deviation 0.89 |
Secondary
Afib 2gether Accuracy Assessment
The provider was asked to review the patients stroke risk score on the AFib 2gether app and compare to provider clinical assessment for accuracy. The number of accurate scores were recorded. Ten of the original thirteen providers completed this assessment.
Time frame: Immediately after visit.
Population: Providers are considered enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient | Afib 2gether Accuracy Assessment | 10 accurate scores |
Secondary
Provider MARS Scores
Providers were asked to navigate the app features and rate their overall opinion of the mobile app by answering questions using the Mobile App Rating Scale (MARS). This scale evaluates 3 domains: functionality, aesthetics, and a star-based rating question. These scores are rated 1-5 with 5 being the highest (best) score.
Time frame: Immediately after visit.
Population: Providers are considered to be enrolled in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient | Provider MARS Scores | Functionality | 4.19 units on a scale | Standard Deviation 0.5 |
| Patient | Provider MARS Scores | Aesthetics | 4.04 units on a scale | Standard Deviation 0.5 |
| Patient | Provider MARS Scores | Star-Based | 3.76 units on a scale | Standard Deviation 0.44 |
Secondary
Reason Why the Patient Was Not on AC Prior to Their Appointment
This was an evaluation of why the patient was not on an anticoagulant (AC) prior to their appointment.
Time frame: Immediately after visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient | Reason Why the Patient Was Not on AC Prior to Their Appointment | Other Bleed | 3 participants |
| Patient | Reason Why the Patient Was Not on AC Prior to Their Appointment | Low AF Burden | 16 participants |
| Patient | Reason Why the Patient Was Not on AC Prior to Their Appointment | Refused | 10 participants |
| Patient | Reason Why the Patient Was Not on AC Prior to Their Appointment | Not Listed | 5 participants |
| Patient | Reason Why the Patient Was Not on AC Prior to Their Appointment | Fall Risk | 1 participants |
| Patient | Reason Why the Patient Was Not on AC Prior to Their Appointment | GI Bleed | 2 participants |
Other Pre-specified
Number of Patients Placed on Anticoagulation After Cardiology Appointment
This outcome measures the number of patient participants with a CHA2DS2-VASc stroke scale score of 2 or higher who are placed on anticoagulation therapy following cardiology appointment. Patients switch to AC will be monitored via the electronic health record. The CHA2DS2-VASc scale is an evaluation of stroke risk for patients with atrial fibrillation. The scale is a composite of 7 questions, with an overall scale score of 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke.
Time frame: up to 6 months
Population: Patients with AF with a stroke risk score that is 2 or higher.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient | Number of Patients Placed on Anticoagulation After Cardiology Appointment | 12 Participants |