Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence

Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence for Patients With Non-valvular Atrial Fibrillation

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Medication Adherence
• Intervention / Treatment: Other: Health Messaging (Non-Procedural)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center; Parkview Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

FOCUS GROUPS:

Inclusion Criteria:

1. Diagnosis of Atrial Fibrillation (Paroxysmal, Persistent, Permanent)

   • focus groups 1 & 2: patients diagnosed ≤ 6 months
   • focus groups 3 & 4: patients diagnosed ≥ 6 months

2. Receiving Oral Anticoagulation -Vitamin K Antagonist (VKA) or Novel Oral Anticoagulant (NOAC)- for non-valvular AF

   • focus groups 1 & 2: on VKA or NOAC
   • focus groups 3 & 4: changed VKA to NOAC within last 6 months
3. *Physically and Mentally capable of providing Informed Consent
4. *Age 18 years or older
5. *Ability to read and understand English

6. Current Patient of Parkview Physicians Group (PPG)-Cardiology

   • 3, 4, and 5 must apply to caregivers, partners, and/or support persons

Exclusion Criteria:

1. Absence of History of Atrial Fibrillation (AF)
2. *Does not meet Inclusion Criteria
3. Anticoagulation with VKA or NOAC for reasons other than non-valvular AF
4. *Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation

5. Currently participating in another Parkview study that involves PHR use

   • Only 2 and 4 apply to caregivers, partners, and/or support persons

TECHNOLOGY TRIAL:

Inclusion Criteria:

1. Diagnosis of Atrial Fibrillation (Paroxysmal, Persistent, Permanent)
2. Receiving Oral Anticoagulation (VKA or NOAC) for non-valvular AF
3. Physically and Mentally capable of providing Informed Consent
4. Age 18 years or older
5. Access to Computer and Internet
6. Ability to read and understand English
7. Current Patient of PPG-Cardiology
8. Willing to have a MyChart account

Exclusion Criteria:

1. Absence of History of Atrial Fibrillation (AF)
2. Does not meet Inclusion Criteria
3. Anticoagulation with VKA or NOAC for reasons other than non-valvular AF
4. Unable to physically or cognitively carry out the tasks necessary for utilizing a PHR such as; blindness, loss of function of arms, cognitive impairments (per chart review) that would interfere in learning a new task
5. Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
6. Currently participating in another Parkview study that involves PHR use
7. Not willing to have a MyChart account

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health Messaging (Non-Procedural); PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Training on the use of MyChart and the AdhereTech smart pill bottle, medication adherence monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle 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. Standard care, training on the use of MyChart and the AdhereTech smart pill bottle, medication adherence monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	AdhereTech smart pill bottles used to collect medication dosing = percentage of allotted doses that were recorded as taken	6 months during study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Portal Login	The number of times participants logged into their patient portal (Epic's MyChart) during the study period was used as a proxy for patient engagement.	6 months during study
Atrial Fibrillation Knowledge	End of study score on Atrial Fibrillation Knowledge scale (min:0 is no knowledge, max: 11 is high knowledge), adjusted for age, baseline knowledge, gender and education level.	6 months
Number of Patients With Incidence of Adverse Events	Adverse events include death, stroke, any embolic event, and/or major bleeding.	6 months during study

Collaborators and Investigators

• Sponsor: Tammy Toscos
• Collaborators: Janssen Scientific Affairs, LLC
• Investigators: Principal Investigator: Tammy Toscos, PhD, Parkview Research Center; Parkview Health; Principal Investigator: Michael Mirro, MD, Parkview Research Center; Parkview Health

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: anticoagulants; Personal Health Records
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PRC15-0709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make individual participant data available.