N/A
N=143
Study of an Intervention to Improve Use of Life-saving Medications for Heart Disease
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT00323258 ↗Enrolled (actual)
143
Serious AEs
—
Results posted
Apr 2012
Primary outcome: Primary: Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months — 91; 94 percentage of participants — p=.50
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- oral education & written tips for remembering medications (Behavioral); pill box (Device); pocket medication card (Device); 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 (Behavioral); Letter to physician/discharge summary (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months |
91; 94 | .50 |
| SECONDARY Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records |
53; 38 | =0.11 |
| SECONDARY Percent of Patients Adherent to Beta-blocker Via Refill Records |
71; 49 | 0.03 sig |
| SECONDARY Percent of Patients Adherent to Statin Via Refill Records |
58; 49 | 0.34 |
| SECONDARY Death in Intervention Patients Compared to Usual Care |
1; 2 | — |
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.
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:
- A diagnosis of unstable angina or acute myocardial infarction (ST segment elevation or non-ST segment elevation myocardial infarction)
- A cardiac catheterization demonstrating CAD greater than or equal to 50 narrowing of artery)
- Prior angioplasty
- Prior coronary artery stent
- 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
Data sourced from ClinicalTrials.gov (NCT00323258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.