Atrial Fibrillation, Medication Adherence
Conditions
Keywords
anticoagulants, Personal Health Records
Brief summary
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.
Detailed description
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.
Interventions
OTHERHealth Messaging (Non-Procedural)
Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.
Sponsors
Janssen Scientific Affairs, LLC
Tammy Toscos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | 6 months during study | AdhereTech smart pill bottles used to collect medication dosing = percentage of allotted doses that were recorded as taken |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Portal Login | 6 months during study | The number of times participants logged into their patient portal (Epic's MyChart) during the study period was used as a proxy for patient engagement. |
| Atrial Fibrillation Knowledge | 6 months | End of study score on Atrial Fibrillation Knowledge scale (min:0 is no knowledge, max: 11 is high knowledge), adjusted for age, baseline knowledge, gender and education level. |
| Number of Patients With Incidence of Adverse Events | 6 months during study | Adverse events include death, stroke, any embolic event, and/or major bleeding. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health Messaging (Non-Procedural) PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Health Messaging (Non-Procedural): Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle. | 80 |
| No Health Messaging No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. | 80 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Health Messaging (Non-Procedural) | No Health Messaging | Total |
|---|---|---|---|
| Age, Continuous | 70.78 years STANDARD_DEVIATION 8.65 | 71.51 years STANDARD_DEVIATION 8.21 | 71.14 years STANDARD_DEVIATION 8.41 |
| Atrial fibrillation diagnosis in previous 12 months No | 63 Participants | 73 Participants | 136 Participants |
| Atrial fibrillation diagnosis in previous 12 months Yes | 17 Participants | 7 Participants | 24 Participants |
| Atrial Fibrillation Knowledge | 6.94 units on a scale STANDARD_DEVIATION 1.93 | 6.59 units on a scale STANDARD_DEVIATION 2.13 | 6.76 units on a scale STANDARD_DEVIATION 2.04 |
| Medication Type Eliquis | 23 Participants | 28 Participants | 51 Participants |
| Medication Type Warfarin | 40 Participants | 40 Participants | 80 Participants |
| Medication Type Xarelto | 17 Participants | 12 Participants | 29 Participants |
| Pre-intervention Patient Portal Logins | 17.80 logins STANDARD_DEVIATION 18.83 | 18.60 logins STANDARD_DEVIATION 20.85 | 18.20 logins STANDARD_DEVIATION 19.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 31 Participants | 29 Participants | 60 Participants |
| Sex: Female, Male Male | 49 Participants | 51 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 7 / 80 | 3 / 80 |
| serious Total, serious adverse events | 4 / 80 | 3 / 80 |
Outcome results
Primary
Medication Adherence
AdhereTech smart pill bottles used to collect medication dosing = percentage of allotted doses that were recorded as taken
Time frame: 6 months during study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Messaging (Non-Procedural) | Medication Adherence | 93.08 percentage of doses recorded as taken | Standard Deviation 0.01 |
| No Health Messaging | Medication Adherence | 89.52 percentage of doses recorded as taken | Standard Deviation 0.01 |
Comparison: estimated adherence rate for the intervention group Generalized linear models were used to test the effect of the intervention on medication adherence. These generalized linear models used a Poisson distribution to estimate the rate of adherence with the log of total prescribed doses as an offset term in the linear predictor.p-value: 0.2895% CI: [92, 95]Regression, Linear
Secondary
Atrial Fibrillation Knowledge
End of study score on Atrial Fibrillation Knowledge scale (min:0 is no knowledge, max: 11 is high knowledge), adjusted for age, baseline knowledge, gender and education level.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Messaging (Non-Procedural) | Atrial Fibrillation Knowledge | 7.31 score on a scale | Standard Deviation 1.92 |
| No Health Messaging | Atrial Fibrillation Knowledge | 6.64 score on a scale | Standard Deviation 2 |
p-value: 0.0395% CI: [-1.14, -0.07]Regression, Linear
Secondary
Number of Patients With Incidence of Adverse Events
Adverse events include death, stroke, any embolic event, and/or major bleeding.
Time frame: 6 months during study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Messaging (Non-Procedural) | Number of Patients With Incidence of Adverse Events | 11 Participants |
| No Health Messaging | Number of Patients With Incidence of Adverse Events | 6 Participants |
Secondary
Patient Portal Login
The number of times participants logged into their patient portal (Epic's MyChart) during the study period was used as a proxy for patient engagement.
Time frame: 6 months during study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Messaging (Non-Procedural) | Patient Portal Login | 42.7 Count of MyChart patient portal logins | Standard Deviation 37 |
| No Health Messaging | Patient Portal Login | 15.9 Count of MyChart patient portal logins | Standard Deviation 16 |
p-value: <0.001Regression, Linear