Use of Electronic Personal Health Records to Improve Medication Adherence

NCT ID: NCT03018197

Last Updated: 2019-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-07-31

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.

Conditions

Atrial Fibrillation; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Medication Education

Patients will receive training on the use of the personal health record and health education via the personal health record.

Group Type: EXPERIMENTAL

Medication Education

Intervention Type: 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.

No Medication Education

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Medication Education

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Medicare and Medicaid Services

FED

Sponsor Role: collaborator

Parkview Health

OTHER

Sponsor Role: lead

Responsible Party

Michael Mirro

Chief Academic and Research Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Mirro, MD

Role: PRINCIPAL_INVESTIGATOR

Parkview Health

Ozlem Ersin, PhD

Role: PRINCIPAL_INVESTIGATOR

Manchester University College of Medicine

Locations

Parkview Research Center; Parkview Health

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

PRC13-0806 ePHR AFib pilot

Identifier Type: -

Identifier Source: org_study_id