Clinical trial NCT00323258: Study of an Intervention to Improve Use of Life-saving Medications for Heart Disease
Official title: PILOT-EBM: Patient Focused Intervention to Improve Long-term Adherence to Evidence Based Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Heart disease
Coronary disease
Patient compliance
Treatment refusal
Pharmacists
Continuity of patient care
Evidence-based medicine
Patient education
Adherence
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2006-05-09
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records
timeFrame: 6 months
measure: Percent of Patients Adherent to Beta-blocker Via Refill Records
timeFrame: 6 months
measure: Percent of Patients Adherent to Statin Via Refill Records
timeFrame: 6 months
measure: Death in Intervention Patients Compared to Usual Care
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Judith M. Kramer, MD,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Nancy Allen LaPointe, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.