Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02690649 |
Other study ID # |
PRC15-0709 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2016 |
Est. completion date |
October 2018 |
Study information
Verified date |
October 2021 |
Source |
Parkview Health |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This is an interventional study designed to develop patient focused strategies that improve
adherence to anticoagulant medication in patients with non-valvular atrial fibrillation (AF).
Outcomes of this work include a novel intervention, as well as information regarding patient
preferences for tailored education.
Description:
This is an interventional study designed to develop patient focused strategies that improve
adherence to anticoagulant medication in patients with non-valvular atrial fibrillation (AF).
Outcomes of this work include a novel intervention, as well as information regarding patient
preferences for tailored education.
There will be two phases in this study. In the first phase, the investigators will use a
patient-centered approach to design and build a personal health record (PHR)-based
educational intervention based on patient preferences for content, timing and delivery
mechanism. In the second phase, the investigators will test the intervention in a six-month
randomized controlled trial.
During the development of the intervention in Phase 1 the investigators will use a
patient-centered, iterative design process that includes interviews, prototype development
and testing. The investigators will recruit a diverse group of AF patients to determine
preferences for information about AF and anticoagulant therapy. The investigators will use a
user-centered design approach and best practices in human-computer interactions (HCI) to
determine the desired content, timing, and delivery of tailored education in the PHR. The
investigators will build out wire-frame models (low fidelity messaging prototypes) based on
focus group findings to perform usability testing and further refine the intervention design.
The intervention component will assess the impact of pushing tailored health education
messages to patients through their PHR. The tailored health education will be specifically
aimed at improving patient compliance with anticoagulant therapy.
One trigger for health education messaging will be failure to take, fill, or refill
anticoagulant medication prescription - information obtained from an e-prescribing data feed
to the electronic medical record (Surescripts) and use of a smart pill bottle (AdhereTech -
HIPAA compliant, FDA-registered Class I medical device) that sends notification in real time
when participants open or fail to open their pill bottle.
The intervention trial in Phase 2 will be comprised of two groups, control and experimental.
Both the control and experimental group will receive standard care, which includes access to
MyChart. In addition to standard care, both groups will receive training on the use of
MyChart and the AdhereTech smart pill bottle, and medication adherence for both groups will
be monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle use.
The experimental group will receive the intervention: tailored health messaging delivered via
MyChart pertinent to AF and oral anticoagulant use.