Dabigatran Adherence Pilot Intervention for Patients With Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01578044
First received: April 3, 2012
Last updated: May 28, 2015
Last verified: May 2015
Results First Received: April 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Atrial Fibrillation
Intervention: Behavioral: Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients who are new starts on dabigatran, apixaban, and rivaroxaban and have completed the initial 3-month pharmacy follow-up will be approached by a pharmacist to inquire about their interest in participating in our study. Patients interested will verbally consent to participate and will then be randomized to the intervention or control group.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention Group

Intervention patients will receive the following:

  1. Patient education: All patients will receive information on their oral anticoagulant, including risks, benefits, and potential side effects. Intervention patients will receive additional materials at the beginning of the study through the mail.
  2. Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.
  3. Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication.
Usual Care

Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.

Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study.


Participant Flow:   Overall Study
    Intervention Group     Usual Care  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Intervention Group

Patients who are randomized to the intervention group will receive the following:

  1. Patient education: Patients will receive information on dabigatran, apixaban, and rivaroxaban, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.
  2. Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.
  3. Pharmacy follow-up: If the anticoagulant has not been refilled, the pharmacy staff will contact the patient to assess reasons the patient has not refilled the medication.
Usual Care Group

Usual care

Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.

Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study.

Total Total of all reporting groups

Baseline Measures
    Intervention Group     Usual Care Group     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     6     6     12  
Age  
[units: Years]
Mean (Full Range)
  70.5   (67 to 78)     69.3   (63 to 84)     69.9   (63 to 84)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     6     6     12  
Region of Enrollment  
[units: participants]
     
United States     6     6     12  



  Outcome Measures

1.  Primary:   Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban   [ Time Frame: 3 and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: P. Michael Ho
Organization: VA Eastern Colorado Health Care System
phone: 720-857-2115
e-mail: michael.ho@va.gov


Publications of Results:
Shore S, Carey E, Turakhia M, Jackevicius CA, Cunningham F, Pilote L, Baron A, Grunwald G, Bradley SM, Maddox TM, Rumsfeld JS, Varosy PD, Ho M. Patterns of Adherence to Dabigatran and its Association with Outcomes. [Abstract]. Circulation. 2013 Nov 26; 128(22 Suppl):A16864.


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01578044     History of Changes
Other Study ID Numbers: RRP 11-424
Study First Received: April 3, 2012
Results First Received: April 27, 2015
Last Updated: May 28, 2015
Health Authority: United States: Federal Government