Study of an Intervention to Improve Use of Life-saving Medications for Heart Disease

Cardiovascular Disease Clinical Trial

— PILOT-EBM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323258
• Other study ID #: Pro00005018
• Secondary ID: U18HS010548
• Status: Completed
• Phase: N/A
• First received: May 5, 2006
• Last updated: January 11, 2013
• Start date: June 2006
• Est. completion date: March 2011

Study information

• Verified date: May 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Device:
• pill box
Subject is provided a pill box and briefly instructed on how to use the box.
• 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.

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.
• 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.
• 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.
• Routine discharge counseling
Both groups received routine discharge counseling performed by the patient-care nurse.

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Agency for Healthcare Research and Quality (AHRQ), Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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. Epub 2006 Jan 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No