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Study of an Intervention to Improve Use of Life-saving Medications for Heart Disease (PILOT-EBM)

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ClinicalTrials.gov Identifier: NCT00323258
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : April 19, 2012
Last Update Posted : January 18, 2013
Sponsor:
Collaborators:
Pfizer
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE May 5, 2006
First Posted Date  ICMJE May 9, 2006
Results First Submitted Date  ICMJE March 19, 2012
Results First Posted Date  ICMJE April 19, 2012
Last Update Posted Date January 18, 2013
Study Start Date  ICMJE June 2006
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months [ Time Frame: 6 months ]
Percent of patients in each group adherent to triple therapy (aspirin/antiplatelet; beta blocker; and statin) 6 months after discharge as assessed by medication history obtained during a follow-up phone call by a blinded pharmacist
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
  • Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records [ Time Frame: 6 months ]
    Percent of patients in each group adherent to beta-blocker and statin for 6 months after discharge as assessed by refill records from the patient's pharmacy
  • Percent of Patients Adherent to Beta-blocker Via Refill Records [ Time Frame: 6 months ]
    According to the local pharmacy records, the patient has had a supply of beta-blocker for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account. % adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes
  • Percent of Patients Adherent to Statin Via Refill Records [ Time Frame: 6 months ]
    According to the local pharmacy records, the patient has had a supply of statin for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account. % adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes
  • Death in Intervention Patients Compared to Usual Care [ Time Frame: 6 months ]
    Number of patients who died in each treatment group prior to the 6 month follow-up time point.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of an Intervention to Improve Use of Life-saving Medications for Heart Disease
Official Title  ICMJE PILOT-EBM: Patient Focused Intervention to Improve Long-term Adherence to Evidence Based Medications
Brief Summary The purpose of this study is to evaluate the effectiveness of a program to help patients with heart disease stay on their heart medications.
Detailed Description

Heart disease is the leading cause of death for men and women in the United States. For patients with documented coronary artery disease (CAD), anti-platelet agents, beta-blockers and statins have all been shown to improve survival and reduce the frequency of myocardial infarction. Yet, previous research by the Duke CERTs has shown that in a population of over 28,000 patients with documented CAD, only 21% reported consistent use of triple therapy with aspirin, beta-blockers and lipid lowering therapy. These results stimulated the Duke CERTs to devise an intervention to improve adherence to these life-saving medications.

Comparisons: Patients admitted to Duke University Hospital or Southeastern Regional Medical Center (SRMC) with CAD or CAD plus heart failure who agree to participate, will be randomized to an intervention or control arm. The control group will receive usual care, which consists of routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the Duke physician to the community physician. In addition to usual care, the intervention group will receive focused medication counseling in the hospital by the clinical pharmacist-investigator, who will identify and address potential barriers to medication adherence and will reinforce the importance of taking evidence-based medications long term. Discharge medications will be shared with the community pharmacist. The community pharmacist will monitor for problems with adherence and communicate issues back to the patient and the patient's care team.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE
  • Behavioral: oral education & written tips for remembering medications
    Clinical pharmacist will review purpose of medications of interest (beta-blockers, statins, Angiotensin Converting Enzyme Inhibitor (ACEI)/Angiotensin Receptor Blocker (ARB), aspirin, and other anti-platelets) with the subject. A written list of tips for remembering medications will be provided and reviewed.
    Other Name: Cue-dose training
  • Device: pill box
    Subject is provided a pill box and briefly instructed on how to use the box.
    Other Names:
    • Pill box organizer
    • pillbox
  • Device: pocket medication card
    Subject is provided with a card that contains space for prescription and non-prescription medications. If desired the clinical pharmacist-investigator will complete the card for the subject.
    Other Names:
    • Medication List
    • List of Medications
  • Behavioral: sharing information with community pharmacist
    A fax is sent to the designated community pharmacy at the time of the subject's discharge from the hospital. The fax contains the subject's medications of interest, barriers to medication adherence, and physicians' contact information.
    Other Name: increased communication with community pharmacist
  • Behavioral: Medication use evaluations by community pharmacist
    The community pharmacist will assess use of medications of interest at time of first medication fill and by reviewing the subject's computerized medication profile at the pharmacy. Assessments occur at first visit to pharmacy, 6-weeks, 12-weeks, 18-weeks, and 24-weeks. If there are issues with any medications of interest the subject will be called. If needed, the subject's health care team will be notified.
    Other Name: medcation adherence verification
  • Behavioral: informing physician if patient has stopped a medication
    The community pharmacist or clinical pharmacist-investigator will fax the subject's physician to notify that a medication has been stopped.
    Other Name: Communication with physician about patient's medication use
  • Behavioral: Routine discharge counseling
    Both groups received routine discharge counseling performed by the patient-care nurse.
    Other Name: Discharge instructions
  • Other: Letter to physician/discharge summary
    A letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations.
    Other Name: Communication to physician about hospital course.
Study Arms  ICMJE
  • Experimental: Intervention
    Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
    Interventions:
    • Behavioral: oral education & written tips for remembering medications
    • Device: pill box
    • Device: pocket medication card
    • Behavioral: sharing information with community pharmacist
    • Behavioral: Medication use evaluations by community pharmacist
    • Behavioral: informing physician if patient has stopped a medication
    • Behavioral: Routine discharge counseling
    • Other: Letter to physician/discharge summary
  • Active Comparator: Usual Care
    The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
    Interventions:
    • Behavioral: Routine discharge counseling
    • Other: Letter to physician/discharge summary
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2010)
143
Original Enrollment  ICMJE
 (submitted: May 5, 2006)
692
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older
  • Utilize a pharmacy in Durham, Robeson, Person, Granville, or Vance County, NC
  • Have coronary artery disease (CAD) documented in the medical record by one of the following:

    1. A diagnosis of unstable angina or acute myocardial infarction (ST segment elevation or non-ST segment elevation myocardial infarction)
    2. A cardiac catheterization demonstrating CAD greater than or equal to 50 narrowing of artery)
    3. Prior angioplasty
    4. Prior coronary artery stent
    5. Prior coronary artery bypass graft surgery (CABG)
  • Plan to have their prescription medications filled and refilled by one of the participating pharmacies
  • Prescribed aspirin or another antiplatelet, a beta-blocker and statin agent (referred to as triple therapy for this study) at discharge. If a patient has a true contraindication to any of the three medication groups in triple therapy, they will still be eligible for the study

Exclusion Criteria:

  • Providers predict an anticipated hospital stay of less than 48 hours
  • Patient plans to use a pharmacy outside of Durham, Robeson, Person, Granville, or Vance County, NC
  • Patient is unable to give consent (cognitively impaired, does not speak English, or has altered mental status)
  • Patient transferred to Cardiothoracic Surgery service for CABG
  • Patient has terminal condition and may not survive until 6-month follow-up
  • Patient lives in a correctional or long-term care facility
  • Patient will be unable to participate in follow-up phone call (hearing impaired without caregiver who can help or does not have a phone)
  • Patient is a known participant in the Duke Heart Failure Program
  • Patient does not agree to use only the one Durham, Robeson, Person, Granville, or Vance County pharmacy throughout the study period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00323258
Other Study ID Numbers  ICMJE Pro00005018
U18HS010548 ( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Pfizer
  • Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Judith M. Kramer, MD,MS Duke University
Principal Investigator: Nancy Allen LaPointe, PharmD Duke University
PRS Account Duke University
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP