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Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02690649
Recruitment Status : Active, not recruiting
First Posted : February 24, 2016
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Tammy Toscos, Parkview Health

Tracking Information
First Submitted Date  ICMJE February 10, 2016
First Posted Date  ICMJE February 24, 2016
Last Update Posted Date October 2, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence
Official Title  ICMJE Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence for Patients With Non-valvular Atrial Fibrillation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Atrial Fibrillation
  • Medication Adherence
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Health Messaging (Non-Procedural)
    PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
    Intervention: Other: Health Messaging (Non-Procedural)
  • No Intervention: No Health Messaging
    No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2019)
160
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2016)
250
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02690649
Other Study ID Numbers  ICMJE PRC15-0709
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.
Responsible Party Tammy Toscos, Parkview Health
Study Sponsor  ICMJE Tammy Toscos
Collaborators  ICMJE Janssen Scientific Affairs, LLC
Investigators  ICMJE
Principal Investigator: Tammy Toscos, PhD Parkview Research Center; Parkview Health
Principal Investigator: Michael Mirro, MD Parkview Research Center; Parkview Health
PRS Account Parkview Health
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP