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

Duke University

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Behavioral: informing physician if patient has stopped a medication; Device: pocket medication card; Other: Letter to physician/discharge summary; Device: pill box; Behavioral: Medication use evaluations by community pharmacist; Behavioral: Routine discharge counseling; Behavioral: sharing information with community pharmacist; Behavioral: oral education & written tips for remembering medications

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT00323258

Pro00005018

U18HS010548 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

143 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: sharing information with community pharmacist

Behavioral: oral education & written tips for remembering medications

Behavioral: Routine discharge counseling

Behavioral: Medication use evaluations by community pharmacist

Other: Letter to physician/discharge summary

Device: pill box

Behavioral: informing physician if patient has stopped a medication

Device: pocket medication card

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Routine discharge counseling

Other: Letter to physician/discharge summary