Our main objective is to conduct a type I hybrid effectiveness/implementation study to test the effectiveness of a successfully-piloted, evidence-based, multi-faceted intervention to improve patient adherence to clopidogrel following percutaneous coronary intervention (PCI). The intervention was developed based on the Chronic Care Model and leverages clinical information systems to deliver team-based coordinated care to activated patients to improve clopidogrel adherence. The study will be evaluated using the RE-AIM framework consisting of the following components, reach, effectiveness, adoption, implementation and maintenance. Clopidogrel is a critical adjuvant therapy following PCI with stent placement and reduces the risk of stent thrombosis, myocardial infarction (MI) and mortality. The American College of Cardiology (ACC)/ American Heart Association (AHA) National Clinical Practice Guidelines recommend clopidogrel for at least 1 month and up to 1 year following stent placement, which is a class 1 indication, the highest level of recommendation in the guidelines. Despite the importance of clopidogrel following stent implantation, adherence gaps are common in the VA, both delays to initial filling of the medication at hospital discharge (~22%) and early discontinuation during longitudinal use (~33%). Early clopidogrel discontinuation increases risk of MI by 78%, death by an absolute increase of 10% and is the largest risk factor for stent thrombosis, elevating the risk by >50-fold . We propose a hybrid effectiveness-implementation study of a multi-faceted intervention to improve clopidogrel adherence at 20 VA PCI sites that builds on our pilot work and leverages the VA's Cardiovascular Assessment Reporting and Tracking in the Cardiac Catheterization Laboratory (CART-CL), a uniform cath lab procedure reporting tool at all VA cath labs. The intervention consists of 4 components: a) a reminder from CART-CL will be sent to the inpatient pharmacist prior to discharge that a patient has received a stent; b) the pharmacist will educate the patients on the importance of and adherence to clopidogrel following PCI, as well as bring clopidogrel to the patient's bedside prior to hospital discharge; c interactive voice response (IVR) calls will be made to patients prior to the time of clopidogrel refill to remind patients and to facilitate refills during follow-up; and d) a Patient Aligned Care Team (PACT) member will contact patients who delay filling clopidogrel. The intervention will be rolled out sequentially to sites (i.e., 4 roll-out phases) in a randomized stepped wedge trial design to test the effectiveness of the intervention to improve adherence and outcomes, and to formatively evaluate and refine the implementation process. During each roll-out phase, we will implement the intervention at 5 sites, and the intervention will be evaluated using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Outcomes for the effectiveness study will include: 1) clopidogrel filled, a dichotomous variable of whether clopidogrel is filled at hospital discharge; and clopidogrel adherence, a continuous measure of adherence based on pharmacy refill data (ReComp) in the year after hospital discharge (primary outcomes); 2) bleeding, myocardial infarction, stroke, and mortality (secondary outcomes); and 3) cost-effectiveness of the intervention (9).
Over 10,000 veterans undergo stent implantation for coronary artery disease in the VA annually. Following the procedure, patients are prescribed clopidogrel, an anti-platelet medication for up to 1 year and it is important to take the medication regularly to prevent recurrent cardiovascular events. However, may patients delay filling clopidogrel at hospital discharge or discontinue the medication early prior to the intend treatment duration. This project will test a multi-faceted intervention to improve clopidogrel adherence after patients undergo stent implantation. The intervention will be tested at 5 sites in each roll-out phase and there will be 4 phases for a total of 20 sites. We will also learn from each roll-out phase to understand barriers and facilitators to implementing the intervention at each site. The goal of the study is to improve clopidogrel adherence and to lower the risk of recurrent cardiovascular events following PCI for veterans.
