Trial record 19 of 123 for:    heart attack OR myocardial infarction OR acute coronary syndrome | Open Studies | NIH, U.S. Fed

Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 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: October 9, 2015
Last verified: October 2015

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 our intervention to improve clopidogrel adherence that builds on our 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. We 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

At the PCI sites, we 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, we 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:

We 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, Mississippi
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS Recruiting
Jackson, Mississippi, United States, 39216
Contact: Walter Woody, MD    601-362-4471 ext 6203   
United States, New Mexico
New Mexico VA Health Care System, Albuquerque, NM Recruiting
Albuquerque, New Mexico, United States, 87108-5153
Contact: D. Miichelle Ratliff, MD    505-265-1711 ext 4494   
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
Louis Stokes VA Medical Center, Cleveland, OH Active, not recruiting
Cleveland, Ohio, United States, 44106
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX Recruiting
Houston, Texas, United States, 77030
Contact: Hani Jneid, MD    713-794-7300 ext 27823   
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

No publications provided

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: October 9, 2015
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Acute Coronary Syndrome
Heart Diseases
Myocardial Ischemia
Cardiovascular Diseases
Angina Pectoris
Chest Pain
Signs and Symptoms
Vascular Diseases
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses processed this record on November 27, 2015