Trial Outcomes & Findings for Dabigatran Adherence Pilot Intervention for Patients With Atrial Fibrillation (NCT NCT01578044)

NCT ID: NCT01578044

Last Updated: 2018-10-10

Results Overview

The investigators will calculate the # of gap days between refills for dabigatran/rivaroxaban/apixaban for each3 and 6 months of the pilot intervention. This will be based on pharmacy refill data and calculated using the date dabigatran/rivaroxaban/apixaban was dispensed and the # of days supplied for that prescription. We will add the # of gap days for each 3 and 6 months of the pilot for each patient, and compare the total # of gaps days between intervention and usual care patients. The gap days between refills is a validated measure of adherence and identifies patients with sub-optimal adherence.A negative gap day value indicates that participants received the refill prior to completion of the previous prescription.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 3 and 6 months
• Results posted on: 2018-10-10

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dabigatran Adherence Pilot Intervention for Patients With Atrial Fibrillation

Baseline characteristics by cohort

Measure	Intervention Group n=6 Participants 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 n=6 Participants 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 n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	70.5 Years n=5 Participants	69.3 Years n=7 Participants	69.9 Years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 and 6 months

The investigators will calculate the # of gap days between refills for dabigatran/rivaroxaban/apixaban for each3 and 6 months of the pilot intervention. This will be based on pharmacy refill data and calculated using the date dabigatran/rivaroxaban/apixaban was dispensed and the # of days supplied for that prescription. We will add the # of gap days for each 3 and 6 months of the pilot for each patient, and compare the total # of gaps days between intervention and usual care patients. The gap days between refills is a validated measure of adherence and identifies patients with sub-optimal adherence.A negative gap day value indicates that participants received the refill prior to completion of the previous prescription.

Outcome measures

Measure	Intervention Group n=6 Participants 1. Patient education: Patients will receive information on dabigatran, 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: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban 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 Group n=6 Participants All usual care patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Additionally, following their time in the study, the usual care patients will receive the additional educational materials the usual care received.
Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban # of Patient gap days for 3-months of intervention	43 days	51 days
Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban # of Patient gap days for 6-months of intervention	41 days	-5 days

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

P. Michael Ho

VA Eastern Colorado Health Care System

Phone: 720-857-2115

Email: michael.ho@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place