Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence

This study is not yet open for participant recruitment.
Verified January 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01609842
First received: March 9, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Department of Veterans Affairs:

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: 48
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phone reminders and pharmacist
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 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

  Eligibility

Ages Eligible for Study:   18 Years to 91 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609842

Contacts
Contact: Michael Ho, MD PhD (720) 857-5115 michael.ho@va.gov
Contact: Christopher L Bryson, MD MS (206) 277-1770 christopher.bryson@va.gov

Locations
United States, Colorado
VA Eastern Colorado Health Care System, Denver Not yet recruiting
Denver, Colorado, United States, 80220
Contact: Robert L Keith, MD    303-399-8020 ext 3182    robert.keith@va.gov   
Contact: Pamela Rice, PhD    (303) 399-8020 ext 3846    Pamela.Rice@va.gov   
Principal Investigator: Michael Ho, MD PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Ho, MD PhD VA Eastern Colorado Health Care System, Denver
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01609842     History of Changes
Other Study ID Numbers: SDP 12-179
Study First Received: March 9, 2012
Last Updated: January 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Acute Coronary Syndrome

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

ClinicalTrials.gov processed this record on April 17, 2014