Clinical trial NCT03018197: Use of Electronic Personal Health Records to Improve Medication Adherence
Official title: The Use of Electronic Personal Health Records to Improve Medication Adherence Among Non-Valvular Atrial Fibrillation Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Medication Adherence
Keywords: Personal Health Record
Medication Knowledge
Anticoagulants
Patient Engagement
Lead sponsor: Parkview Health
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
First posted: 2017-01-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Medication Adherence evaluated through medication possession ratios
timeFrame: 3 months during study
Secondary outcomes:
measure: Patient Engagement evaluated through Patient Activation Measure (PAM)
timeFrame: 3 months during study
measure: Medication Knowledge evaluated through 5-question survey
timeFrame: 3 months during study
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Parkview Research Center; Parkview Health
state: Indiana
Study officials:
affiliation: Parkview Health
name: Michael Mirro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manchester University College of Medicine
name: Ozlem Ersin, PhD
role: PRINCIPAL_INVESTIGATOR
References: