Clinical trial NCT02690649: Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence
Official title: Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence for Patients With Non-valvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Medication Adherence
Keywords: anticoagulants
Personal Health Records
Lead sponsor: Parkview Health
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2016-02-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication Adherence
timeFrame: 6 months during study
Secondary outcomes:
measure: Patient Portal Login
timeFrame: 6 months during study
measure: Atrial Fibrillation Knowledge
timeFrame: 6 months
measure: Number of Patients With Incidence of Adverse Events
timeFrame: 6 months during study
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Parkview Research Center; Parkview Health
state: Indiana
Study officials:
affiliation: Parkview Research Center; Parkview Health
name: Tammy Toscos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Parkview Research Center; Parkview Health
name: Michael Mirro, MD
role: PRINCIPAL_INVESTIGATOR
References: