Use of Electronic Personal Health Records to Improve Medication Adherence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of Electronic Personal Health Records to Improve Medication Adherence Among Non-Valvular Atrial Fibrillation Patients: A Pilot Study

Conditions
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Atrial Fibrillation, Medication Adherence

Intervention / Treatment
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* Other: Medication Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patient of Parkview Physicians Group-Cardiology Currently on dabigatran for non-valvular atrial fibrillation Out-patient status Ability to read and understand English Access to the Internet Ability to utilize the computer and Internet Willingness to enroll in a MyChart account Exclusion Criteria: Physical or cognitive disability hindering provision of the informed consent process or performance of study tasks Unable to physically or cognitively carry out the tasks necessary for activating and/or utilizing a personal health record Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation Currently part of another study involving another type of personal health record (other than MyChart)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication Education<br>Patients will receive training on the use of the personal health record and health education via the personal health record. | Other: Medication Education<br>* 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.<br>|
| No Intervention: No Medication Education<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence evaluated through medication possession ratios |  | 3 months during study | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulants, Personal Health Record, Medication Knowledge, Patient Engagement