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

Not Applicable

Completed

Conditions: Cardiovascular Disease

Interventions: 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

Registration Number: NCT00323258

Lead Sponsor: Duke University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 143

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	oral education & written tips for remembering medications	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.
Intervention	pill box	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.
Intervention	pocket medication card	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.
Intervention	sharing information with community pharmacist	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.
Intervention	Medication use evaluations by community pharmacist	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.
Intervention	informing physician if patient has stopped a medication	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.
Intervention	Routine discharge counseling	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.
Intervention	Letter to physician/discharge summary	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.
Usual Care	Routine discharge counseling	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.
Usual Care	Letter to physician/discharge summary	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.

Primary Outcome Measures

Name	Time	Method
Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months	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

Secondary Outcome Measures

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