Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence

This is an interventional study designed to develop patient focused strategies that improve
adherence to anticoagulant medication in patients with non-valvular atrial fibrillation
(AF). Outcomes of this work include a novel intervention, as well as information regarding
patient preferences for tailored education.

There will be two phases in this study. In the first phase, the investigators will use a
patient-centered approach to design and build a personal health record (PHR)-based
educational intervention based on patient preferences for content, timing and delivery
mechanism. In the second phase, the investigators will test the intervention in a six-month
randomized controlled trial.

During the development of the intervention in Phase 1 the investigators will use a
patient-centered, iterative design process that includes interviews, prototype development
and testing. The investigators will recruit a diverse group of AF patients to determine
preferences for information about AF and anticoagulant therapy. The investigators will use a
user-centered design approach and best practices in human-computer interactions (HCI) to
determine the desired content, timing, and delivery of tailored education in the PHR. The
investigators will build out wire-frame models (low fidelity messaging prototypes) based on
focus group findings to perform usability testing and further refine the intervention
design. The intervention component will assess the impact of pushing tailored health
education messages to patients through their PHR. The tailored health education will be
specifically aimed at improving patient compliance with anticoagulant therapy.

One trigger for health education messaging will be failure to take, fill, or refill
anticoagulant medication prescription - information obtained from an e-prescribing data feed
to the electronic medical record (Surescripts) and use of a smart pill bottle (AdhereTech -
HIPAA compliant, FDA-registered Class I medical device) that sends notification in real time
when participants open or fail to open their pill bottle.

The intervention trial in Phase 2 will be comprised of two groups, control and experimental.
Both the control and experimental group will receive standard care, which includes access to
MyChart. In addition to standard care, both groups will receive training on the use of
MyChart and the AdhereTech smart pill bottle, and medication adherence for both groups will
be monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle use.
The experimental group will receive the intervention: tailored health messaging delivered
via MyChart pertinent to AF and oral anticoagulant use.

FOCUS GROUPS:

Inclusion Criteria:

1. Diagnosis of Atrial Fibrillation (Paroxysmal, Persistent, Permanent)

- focus groups 1 & 2: patients diagnosed ≤ 6 months

- focus groups 3 & 4: patients diagnosed ≥ 6 months

2. Receiving Oral Anticoagulation -Vitamin K Antagonist (VKA) or Novel Oral
Anticoagulant (NOAC)- for non-valvular AF

- focus groups 1 & 2: on VKA or NOAC

- focus groups 3 & 4: changed VKA to NOAC within last 6 months

3. *Physically and Mentally capable of providing Informed Consent

4. *Age 18 years or older

5. *Ability to read and understand English

6. Current Patient of Parkview Physicians Group (PPG)-Cardiology

- 3, 4, and 5 must apply to caregivers, partners, and/or support persons

Exclusion Criteria:

1. Absence of History of Atrial Fibrillation (AF)

2. *Does not meet Inclusion Criteria

3. Anticoagulation with VKA or NOAC for reasons other than non-valvular AF

4. *Designated as part of a vulnerable subject population that the investigator or
designee identifies to have compromised autonomy related to potential study
participation

5. Currently participating in another Parkview study that involves PHR use

- Only 2 and 4 apply to caregivers, partners, and/or support persons

TECHNOLOGY TRIAL:

Inclusion Criteria:

1. Diagnosis of Atrial Fibrillation (Paroxysmal, Persistent, Permanent)

2. Receiving Oral Anticoagulation (VKA or NOAC) for non-valvular AF

3. Physically and Mentally capable of providing Informed Consent

4. Age 18 years or older

5. Access to Computer and Internet

6. Ability to read and understand English

7. Current Patient of PPG-Cardiology

8. Willing to have a MyChart account

Exclusion Criteria:

1. Absence of History of Atrial Fibrillation (AF)

2. Does not meet Inclusion Criteria

3. Anticoagulation with VKA or NOAC for reasons other than non-valvular AF

4. Unable to physically or cognitively carry out the tasks necessary for utilizing a PHR
such as; blindness, loss of function of arms, cognitive impairments (per chart
review) that would interfere in learning a new task

5. Designated as part of a vulnerable subject population that the investigator or
designee identifies to have compromised autonomy related to potential study
participation

6. Currently participating in another Parkview study that involves PHR use

7. Not willing to have a MyChart account