BACKGROUND/RATIONALE:
This was a pilot feasibility study to improve adherence to clopidogrel after a patient undergoes a cardiac procedure that places one or more drug eluting stents (DES) in their coronary arteries.

Prior studies have found that adherence to clopidogrel following DES implantation is poor. In an analysis of 7,402 patients we found that 11% of patients had a delay of greater than 1 day in filling their initial clopidogrel prescription. Furthermore, 165 (2.2%) patients never filled a prescription. These patients had significantly increased risk of death/MI (HR 1.53; 95% CI 1.19-1.96) as well as death alone. Another study found 13.6% or 1 in 7 patients discontinued the medication within 30 days of hospital discharge. Patients who discontinued clopidogrel early had increased risk of rehospitalization (HR 1.5; 95% CI 0.78-3.0) or mortality (HR 9.0; 95% CI 1.3-60.0) in the subsequent 11 months. These studies demonstrate that non-adherence to clopidogrel occurs early following hospital discharge and highlights an important opportunity to improve care for patients undergoing DES implantation.

The current practice at most VA facilities is that patients are prescribed clopidogrel following hospital discharge for DES implantation and it is assumed that patients will pick up the medication as prescribed. Some centers call patients following discharge and/or schedule a post-discharge follow-up visit but there is no specific mechanism to ensure that patients have filled their prescription for clopidogrel. This pilot intervention addressed this care gap by implementing a mechanism to identify patients who have not filled their clopidogrel prescription in a timely manner and a pilot intervention to facilitate receipt of clopidogrel.

OBJECTIVE(S):
We hypothesized that a multi-modal intervention utilizing the VA Cardiovascular Assessment Reporting and Tracking Cath Lab (CART-CL) system and an interactive voice response (IVR) system would improve adherence to clopidogrel following hospital discharge for DES implantation.

The specific aims were to:
1) develop a computerized alert used by study personnel that identified patients that had not filled their clopidogrel prescription following DES implantation

2) develop an IVR message reminding patients to fill and take their clopidogrel as prescribed

3) pilot test the alerts and IVR messages among patients following DES implantation at Denver and Durham VA Medical Centers, which consecutively collected patients beginning on one specific day and follow them over 4 months.

METHODS:
The first two phases of the study created the computerized alerts and the IVR messages to patients.

The intervention assessed the application of the alerts and the telephone messages.
Inclusion: Patients undergoing DES implantation in 1 coronary artery.
Exclusion: Patients already taking clopidogrel and patient receiving bare-metal stents.

We observed each patient for 4 months. If the patient did not fill their clopidogrel prescription at the time of hospital discharge, an alert was generated within CART-CL and a member of the research team who would contact the patient to assess reasons for not filling and to facilitate receipt of the medication. If the patient filled the prescription the patient was not contacted.

The project manager contacted all patients one week after their discharge from the hospital and informed them about the upcoming IVR messages. She informed the patient that they were part of the study and asked to have an interview four months after they were discharged to give feedback about their experience and sign the Informed Consent and HIPAA authorization.

Two types of messages were sent to the participants over four months. The medication refill calls occurred 14 and 7 days prior to the refill due date, and on the due date. The educational medication adherence calls occurred on days 30, 60, and 90, following hospital discharge.

At four months following the discharge a follow up telephone interview occurred to get feedback about the intervention components.

FINDINGS/RESULTS:
Of the eighteen participants:
-All but one picked up their clopidogrel at discharge. The 1 patient said he would use his community pharmacy.
-Six patients said they received the reminder messages.
-Five patients said they received the educational messages.
-We had a 74% completed refill call rate with 49 successful calls.
-We had a 61% completed educational call rate with 40 successful calls.

Many calls were answered by voice mails, which may explain why some patients did not remember receiving them.

Patient feedback on the refill calls:
Most participants (83%) believed the refill messages were or would be helpful in refilling prescriptions. One said "So it wouldn't bother me the positive part would be that it's a reminder and apparently somebody cares." Two patients with co-morbidities indicated the difficulty of handling multiple tasks and that the reminders would be very helpful. A few shared that the messages also supported refilling other medications and reminding patients to ask clarifying questions about other medications.

Educational calls:
Most study participants (77%) said the educational calls were or would be helpful. One said "It would probably be good to know the dangers there cause I'm not exactly well versed on why I need to do these things" another added "I do, I think more communication on some of these meds would explain why we have to take them and what the purpose of it is" and another said "I never even had a doctor explain to me what the benefits of plavix were."

One patient commented that "he was quite impressed that people were following up on the medication, which was a good thing."

IMPACT:
The findings of this study will provide the pilot data for a larger implementation project to improve clopidogrel adherence and outcomes of veterans following DES implantation.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Rumsfeld JS, Alexander KP, Goff DC, Graham MM, Ho PM, Masoudi FA, Moser DK, Roger VL, Slaughter MS, Smolderen KG, Spertus JA, Sullivan MD, Treat-Jacobson D, Zerwic JJ, American Heart Association Council on Quality of Care and Outcomes Research, Council on Cardiovascular and Stroke Nursing, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Stroke Council. Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation. 2013 Jun 4; 127(22):2233-49. [view]

DRA: Cardiovascular Disease
DRE: Treatment - Observational, Technology Development and Assessment
Keywords: Adherence, Cardiac procedures, Quality assurance, improvement
MeSH Terms: none