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Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: March 9, 2012
Last updated: August 16, 2016
Last verified: August 2016

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.

Condition Intervention
Cardiovascular Disease
Acute Coronary Syndrome
Other: Multifaceted Intervention with pharmacist and IVR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Medication adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The proportion of patients whose clopidogrel prescription is filled at hospital discharge following the PCI stent placement as well as the proportion of patients who are adherent based on the pharmacy refill data (ReComp) in the year after hospital discharge.

Estimated Enrollment: 2500
Study Start Date: January 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phone reminders and pharmacist
An alerted inpatient pharmacist or a designated study team member will bring the clopidogrel medication to the patient who has received a coronary stent. The patient will return home and receive IVR refill reminder calls.
Other: Multifaceted Intervention with pharmacist and IVR
An alerted inpatient pharmacists will bring the clopidogrel medication to the patient who has received a stent. The patient will return home and receive IVR messages about the importance of their medication as well as a refill reminder call.
Usual Care
The sites will have no interaction with the study personnel. The investigators will use database information to compare with the intervention sites
Other: Multifaceted Intervention with pharmacist and IVR
An alerted inpatient pharmacists will bring the clopidogrel medication to the patient who has received a stent. The patient will return home and receive IVR messages about the importance of their medication as well as a refill reminder call.

  Show Detailed Description


Ages Eligible for Study:   18 Years to 91 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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),
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01609842

Contact: Michael Ho, MD PhD (720) 857-5115

United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO Active, not recruiting
Denver, Colorado, United States, 80220
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC Active, not recruiting
Washington, District of Columbia, United States, 20422
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Recruiting
Gainesville, Florida, United States, 32608
Contact: Anthony Bavry, MD    352-376-1611 ext 4726   
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Kreton Mavromatis, MD    404-321-6111 ext 2207   
United States, Iowa
Iowa City VA Health Care System, Iowa City, IA Not yet recruiting
Iowa City, Iowa, United States, 52246-2208
Contact: Saket Girotra    319-338-0581 ext 5200   
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Paul Grossman, MD    734-845-3455   
United States, Mississippi
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS Active, not recruiting
Jackson, Mississippi, United States, 39216
United States, New Mexico
New Mexico VA Health Care System, Albuquerque, NM Active, not recruiting
Albuquerque, New Mexico, United States, 87108-5153
United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY Active, not recruiting
New York, New York, United States, 10010
United States, North Carolina
Durham VA Medical Center, Durham, NC Active, not recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati VA Medical Center, Cincinnati, OH Active, not recruiting
Cincinnati, Ohio, United States, 45220
Louis Stokes VA Medical Center, Cleveland, OH Active, not recruiting
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Oklahoma City VA Medical Center, Oklahoma City, OK Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Faisal Latif, MD    405-456-3686   
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX Active, not recruiting
Houston, Texas, United States, 77030
United States, Virginia
Salem VA Medical Center, Salem, VA Active, not recruiting
Salem, Virginia, United States, 24153
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Michael Ho, MD PhD VA Eastern Colorado Health Care System, Denver, CO
  More Information

Responsible Party: VA Office of Research and Development Identifier: NCT01609842     History of Changes
Other Study ID Numbers: SDP 12-179 
Study First Received: March 9, 2012
Last Updated: August 16, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
Acute Coronary Syndrome

Additional relevant MeSH terms:
Cardiovascular Diseases
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on October 25, 2016