N/A
N=6,081
Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence
Cardiovascular Disease · Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01609842 ↗Enrolled (actual)
6,081
Serious AEs
12.9%
Results posted
Jan 2020
Primary outcome: Primary: Percentage of Adherent Patients — 590; 4484; 2209; 3633 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multifaceted Intervention with pharmacist and IVR (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Adherent Patients |
590; 4484; 2209; 3633 | — |
| PRIMARY Percentage of Participants With Anti-Platelet Medication Delay |
35; 459; 210; 578 | — |
| PRIMARY Mean PDC |
0.912; 0.851; 0.867; 0.858 | — |
| SECONDARY Hospitalizations |
99; 792; 387; 603 | — |
| SECONDARY Mortality |
34; 399; 193; 266 | — |
Summary
Percutaneous coronary intervention (PCI) is a common invasive cardiovascular procedure performed in the VA with over 13,000 procedures in FY10. Clopidogrel is a critical adjuvant therapy following PCI with stent placement and is generally recommended for up to 1 year following the procedure. Despite the evidence supporting clopidogrel use, studies both outside and within the VA suggest that poor adherence to clopidogrel is common. However, prior interventions targeting non-adherence have not specifically focused on clopidogrel adherence among PCI patients.
There are many potential reasons for early clopidogrel discontinuation that involve patient and healthcare system factors. Patients reported the following reasons for discontinuing clopidogrel within 1 month after drug-eluting stent (DES) implantation: 1) misunderstanding the intended treatment duration; 2) conflicting recommendations about intended duration; 3) cost of the medication; and 4) patients' own decision to stop. In contrast, patients who continued to take clopidogrel reported the following as helpful: 1) communication such as letters from their physician; and 2) receiving specific instructions on clopidogrel use. These findings suggest that there are specific interventions that can be implemented to improve clopidogrel adherence.
Multi-modal interventions that incorporate frequent follow-up, especially with pharmacists and use interactive voice response (IVR) technology have improved medication adherence. IVR technology is a computer-based telephone system which initiates calls, receives calls, provides information, and collects data from users. IVR is currently a mainstay in the VA where patients frequently interact with these automated systems to get clinic appointments and/or refill prescriptions. IVR as part of multi-modal interventions have been well received by patients, increased adherence to medications (e.g., statins), and improved clinical outcomes (e.g., blood pressure, diabetes symptoms, health status). In addition, the investigators have successfully used IVR as part of a multi-modal, multi-site intervention including pharmacists to improve blood pressure levels among hypertensive patients. Accordingly, the investigators have designed the intervention to improve clopidogrel adherence that builds on the investigators' prior work and other successful adherence interventions from the literature.
The investigators propose a hybrid effectiveness-implementation study of a multi-faceted intervention to improve clopidogrel adherence at VA PCI centers. The investigators will use the VA's Cardiovascular Assessment Reporting and Tracking (CART-CL), a uniform cath lab procedure reporting tool at all VA cath labs. The intervention consists of 4 components: a) an alert from CART-CL will be sent to an inpatient pharmacist prior to discharge that a patient has received a stent; b) a pharmacist will bring clopidogrel to the patient's bedside prior to hospital discharge as well as educate the patient on the importance of and adherence to clopidogrel following PCI; 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.
Eligibility Criteria
Inclusion Criteria
At the PCI sites, the investigators will include
- all patients undergoing PCI with either a bare-metal (BMS) or drug-eluting stent (DES) and are prescribed clopidogrel regardless of the intended treatment duration
- other potential anti-platelet medications (thienopyridines) used following PCI to accommodate changes in practice (e.g., prasugrel or ticagrelor or ticlopidine).
- all patients undergoing PCI and receiving clopidogrel at the randomized sites, regardless of gender, ethnicity or race. Based on data from the national CART Program, the investigators anticipate ~23% minorities (African American 16.8%, Hispanic 4.4%, Asian/American Indian 1.4%) and 3.1 women will be included in the study.
Exclusion Criteria
The investigators will exclude
- sites with low PCI volume,
- less than 20 PCI procedures performed during the last fiscal year (n=3),
Data sourced from ClinicalTrials.gov (NCT01609842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.