The investigators propose to evaluate the implementation of an efficacious medication adherence program in a group at high risk for CVD. The program involves patients receiving/responding to e-reminders to take CVD medications via patient-selected technology \[mobile/web-based applications, short message service (SMS; text messaging), interactive voice response (IVR), or e-mail\] supported by a tailored, monthly, self-management program administered by either research staff or a case manager staff member from the Duke Outpatient Clinic via the telephone. This is a hybrid type II implementation science study.
The investigators propose to evaluate the implementation of a medication adherence program among patients who attend Duke Outpatient Clinic (DOC). It is anticipated that, among the providers' patient panels, at least 100 and up to 300 with CVD risk and poor CVD medication adherence (\<0.08 medication possession ratio) will consent to the program. Using procedures from the investigators previous studies, the investigators will identify potential patients from the EHR, and will identify a pool of potential patients using electronic health records, with the goal of administering the program to at least 100 patients. Patients will be mailed letters, signed by their own provider or medical director of DOC, requesting their participation in the programs. The RA will contact patients via telephone to explain the study, screen for eligibility, and determine what mode of administration individuals prefer to receive the program (SMS, IVR, or email). The primary outcome will be that the effectiveness/impact of the proposed adherence program will be a 10% improvement in MPR and CVD outcomes (anticipate reducing SBP by 5 mmHg, Hgb a1c by 0.5%, LDL-C by 20 mg/dl).
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
100
Patients will receive e-reminders via text message and email. A message library that allows us to disseminate constant and reliable information has been created. Messages will contain not only medication reminders, but information about issues related to self-management and medication adherence for CVD risk including messages on side-effects, risks/benefits of medication treatment, and barriers to medication adherence. In addition to these messages, patients will also receive tailored information via telephone by trained research staff.
Duke University Health System Clinic
Durham, North Carolina, United States
Adherence to the program's intervention
It is measured as the proportion of technology or interventionist contacts responded to by a patient out of those received over the course of the intervention period. This will be summarized descriptively by type of contact (technology vs. interventionist call) and subdivided by technology (SMS, email).
Time frame: 6 months
Clinical effectiveness/impact of the program to pill refill adherence
This will be measured by pulling pill refill records of those patients who are enrolled. The investigators anticipate an improvement of 10% on pill refill adherence.
Time frame: 6 months
Clinical effectiveness/impact on BP
This will be measured by assessing systolic BP values. The investigators anticipate reducing SBP by 5 mmHg.
Time frame: 6 months
Clinical effectiveness/impact on A1C
This will be measured by assessing A1C values. The investigators anticipate reducing Hgb A1c by 0.5%.
Time frame: 6 months
Clinical effectiveness/impact on cholesterol
This will be measured by assessing LDL-C levels in patients. The goal is to reduce LDL-C levels by 20 mg/dl.
Time frame: 6 months
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