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Use of Electronic Personal Health Records to Improve Medication Adherence

Primary Purpose

Atrial Fibrillation, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication Education
Sponsored by
Parkview Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring Personal Health Record, Medication Knowledge, Anticoagulants, Patient Engagement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Parkview Research Center; Parkview Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Medication Education

No Medication Education

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Medication Adherence evaluated through medication possession ratios

Secondary Outcome Measures

Patient Engagement evaluated through Patient Activation Measure (PAM)
Medication Knowledge evaluated through 5-question survey

Full Information

First Posted
January 10, 2017
Last Updated
August 27, 2019
Sponsor
Parkview Health
Collaborators
Centers for Medicare and Medicaid Services
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1. Study Identification

Unique Protocol Identification Number
NCT03018197
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parkview Health
Collaborators
Centers for Medicare and Medicaid Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Medication Adherence
Keywords
Personal Health Record, Medication Knowledge, Anticoagulants, Patient Engagement

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication Education
Arm Type
Experimental
Arm Description
Patients will receive training on the use of the personal health record and health education via the personal health record.
Arm Title
No Medication Education
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Medication Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Adherence evaluated through medication possession ratios
Time Frame
3 months during study
Secondary Outcome Measure Information:
Title
Patient Engagement evaluated through Patient Activation Measure (PAM)
Time Frame
3 months during study
Title
Medication Knowledge evaluated through 5-question survey
Time Frame
3 months during study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Mirro, MD
Organizational Affiliation
Parkview Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ozlem Ersin, PhD
Organizational Affiliation
Manchester University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkview Research Center; Parkview Health
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available.

Learn more about this trial

Use of Electronic Personal Health Records to Improve Medication Adherence

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