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| Name | Class |
|---|---|
| Centers for Medicare and Medicaid Services | FED |
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The purpose of this pilot study is to examine the use of a personal health record to improve medication adherence among patients with non-valvular atrial fibrillation taking dabigatran for primary prevention of embolic stroke.
Three brief newsletters will be sent by the research staff to the study patients in the form of secure messages through their MyChart account. The newsletters will describe dabigatran tolerability, adverse effects, patient monitoring, warnings/precautions, and administration. Newsletters will be developed through a review of the FDA-approved prescribing information, general tertiary references, and a search of PubMed and drafted with guidance from a Drug Information Specialist at Manchester University College of Pharmacy as well as reviewed by the research staff.
Descriptive analysis will be used to analyze the survey to assess patient attitudes and beliefs about dabigatran and personal health records, as well as to assess the level of patient engagement. Difference-in-difference regression analysis will be used to evaluate the impact of the personal health record on dabigatran adherence by comparing the differences between times (pre-post) and interventions. Patient medication adherence will be correlated from the Pharmacy refill data to determine if the Intervention Group is more compliant than the Control Group. Multivariate analysis will be used to explore factors influencing personal health record use and dabigatran adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication Education | Experimental | Patients will receive training on the use of the personal health record and health education via the personal health record. |
|
| No Medication Education | No Intervention | Patients will receive the current standard of care for the personal health record. Patients will not receive training on the use of the personal health record or health education via the personal health record. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication Education | Other | Medication education delivered via the personal health record (MyChart) pertinent to the anticoagulation medication dabigatran. Education newsletters will be sent at 4, 6, and 10 weeks post-enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence evaluated through medication possession ratios | 3 months during study |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Engagement evaluated through Patient Activation Measure (PAM) | 3 months during study | |
| Medication Knowledge evaluated through 5-question survey | 3 months during study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Mirro, MD | Parkview Health | Principal Investigator |
| Ozlem Ersin, PhD | Manchester University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkview Research Center; Parkview Health | Fort Wayne | Indiana | 46845 | United States |
There is no plan to make individual participant data available.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D055118 | Medication Adherence |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |