Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690649
• Other study ID #: PRC15-0709
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Medication Adherence

Intervention

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.

Locations

Country	Name	City	State
United States	Parkview Research Center; Parkview Health	Fort Wayne	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Tammy Toscos	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Patients With Incidence of Adverse Events	Adverse events include death, stroke, any embolic event, and/or major bleeding.	6 months during study