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

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00323258
First received: May 5, 2006
Last updated: January 11, 2013
Last verified: May 2012
  Purpose

The purpose of this study is to evaluate the effectiveness of a program to help patients with heart disease stay on their heart medications.


Condition Intervention
Cardiovascular Disease
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: PILOT-EBM: Patient Focused Intervention to Improve Long-term Adherence to Evidence Based Medications

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Number of patients who died in each treatment group prior to the 6 month follow-up time point.


Enrollment: 143
Study Start Date: June 2006
Study Completion Date: March 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00323258

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Duke University
Pfizer
Investigators
Principal Investigator: Judith M. Kramer, MD,MS Duke University
Principal Investigator: Nancy Allen LaPointe, PharmD Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00323258     History of Changes
Other Study ID Numbers: Pro00005018, U18HS10548
Study First Received: May 5, 2006
Results First Received: March 19, 2012
Last Updated: January 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Heart disease
Coronary disease
Patient compliance
Treatment refusal
Pharmacists
Continuity of patient care
Evidence-based medicine
Patient education
Adherence

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014