Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence
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|ClinicalTrials.gov Identifier: NCT02690649|
Recruitment Status : Active, not recruiting
First Posted : February 24, 2016
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Medication Adherence||Other: Health Messaging (Non-Procedural)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence for Patients With Non-valvular Atrial Fibrillation|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||February 2020|
Experimental: Health Messaging (Non-Procedural)
PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Other: Health Messaging (Non-Procedural)
Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.
No Intervention: No Health Messaging
No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
- Medication Adherence evaluated through patient survey [ Time Frame: 6 months during study ]The Morisky medication adherence scale will be used.
- Medication Adherence evaluated through prescription refill data [ Time Frame: 6 months during study ]Surescripts e-prescribing software will be used to collect prescription refill data
- Medication Adherence evaluated through smart pill bottle data [ Time Frame: 6 months during study ]AdhereTech smart pill bottles will be used to collect medication dosing data
- Incidence of Adverse Events [ Time Frame: 6 months during study ]Adverse events include death, stroke, any embolic event, and/or major bleeding.
- Patient Engagement evaluated through Altarum Consumer Engagement (ACE) Measure [ Time Frame: 6 months during study ]This validated survey instrument will be utilized in the patient survey to evaluate patient engagement.
- Patient Engagement evaluated through Patient Activation Measure (PAM) [ Time Frame: 6 months during study ]This validated survey instrument will be utilized in the patient survey to evaluate patient engagement.
- Patient Engagement evaluated through PHR login frequency [ Time Frame: 6 months during study ]
- Patient Engagement evaluated through calls to clinic [ Time Frame: 6 months during study ]
- Health Literacy evaluated through Atrial Fibrillation Knowledge Scale [ Time Frame: 6 months during study ]This validated survey instrument will be utilized in the patient survey to evaluate health literacy.
- Health Literacy evaluated through Newest Vital Sign (NVS) [ Time Frame: 6 months during study ]This validated survey instrument will be utilized in the patient survey to evaluate health literacy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690649
|United States, Indiana|
|Parkview Research Center; Parkview Health|
|Fort Wayne, Indiana, United States, 46845|
|Principal Investigator:||Tammy Toscos, PhD||Parkview Research Center; Parkview Health|
|Principal Investigator:||Michael Mirro, MD||Parkview Research Center; Parkview Health|