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

PILOT-EBM: Patient Focused Intervention to Improve Long-term Adherence to Evidence Based Medications

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: 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

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: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: Communication to physician about hospital course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records	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	6 months
Percent of Patients Adherent to Beta-blocker Via Refill Records	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	6 months
Percent of Patients Adherent to Statin Via Refill Records	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	6 months
Death in Intervention Patients Compared to Usual Care	Number of patients who died in each treatment group prior to the 6 month follow-up time point.	6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Pfizer; Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Judith M. Kramer, MD,MS, Duke University; Principal Investigator: Nancy Allen LaPointe, PharmD, Duke University

Publications and helpful links

General Publications

• Newby LK, LaPointe NM, Chen AY, Kramer JM, Hammill BG, DeLong ER, Muhlbaier LH, Califf RM. Long-term adherence to evidence-based secondary prevention therapies in coronary artery disease. Circulation. 2006 Jan 17;113(2):203-12. doi: 10.1161/CIRCULATIONAHA.105.505636. Epub 2006 Jan 9.
• Calvert SB, Kramer JM, Anstrom KJ, Kaltenbach LA, Stafford JA, Allen LaPointe NM. Patient-focused intervention to improve long-term adherence to evidence-based medications: a randomized trial. Am Heart J. 2012 Apr;163(4):657-65.e1. doi: 10.1016/j.ahj.2012.01.019.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: May 5, 2006
• First Submitted That Met QC Criteria: May 5, 2006
• First Posted (Estimate): May 9, 2006

Study Record Updates

• Last Update Posted (Estimate): January 18, 2013
• Last Update Submitted That Met QC Criteria: January 11, 2013
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Adherence; Patient education; Heart disease; Coronary disease; Patient compliance; Pharmacists; Evidence-based medicine; Continuity of patient care; Treatment refusal
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: Pro00005018; U18HS010548 (U.S. AHRQ Grant/Contract)