Study of an Intervention to Improve Use of Life-Saving Medications for Heart Disease - Full Text View

Sponsors and Collaborators:	Duke University Pfizer Agency for Healthcare Research and Quality (AHRQ)
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00323258

Purpose

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

Condition	Intervention
Cardiovascular Disease	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

MedlinePlus related topics: Heart Diseases Statins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
Official Title:	PILOT-EBM: Patient Focused Intervention to Improve Long-Term Adherence to Evidence Based Medications

Further study details as provided by Duke University:

Primary Outcome Measures:

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent of patients in each group adherent to triple therapy for 6 months after discharge as assessed by refill records from the patient's pharmacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Adherence to each individual medication class in triple therapy and ACEI or ARB at 6 months by follow up phone call and by prescription refill records for beta-blocker, statin and ACEI/ARB and by follow up phone call only for antiplatelet medications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Adherence to ACEI or ARB and BB in patients who also have a HF diagnosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Adherence to other cardiovascular medications that are prescribed at discharge but are not included in one of the four classes of interest [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Patient reported rehospitalizations in intervention compared to usual care group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Patient reported rehospitalizations by adherence status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Death in intervention patients compared to usual care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Correlation between patient reported medication use, refill records and Morisky adherence scale (MAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Medication adherence for 1 year after 6 month follow up by pharmacy refill records [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	282
Study Start Date:	June 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intervention: Experimental Patients enrolled in the intervention arm will receive 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 will be provided. The community pharmacist will be notified of the subject's enrollment. The community pharmacist will be asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem is noted the subject's health care team will be notified.	Behavioral: oral education & written tips for remembering medications Clinical pharmacist will review purpose of medications of interest (beta-blockers, statins, ACEI/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. Device: 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. Behavioral: 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. Behavioral: 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.

Arms

Assigned Interventions

Intervention: Experimental

Patients enrolled in the intervention arm will receive 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 will be provided. The community pharmacist will be notified of the subject's enrollment. The community pharmacist will be asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem is noted the subject's health care team will be notified.

Behavioral: oral education & written tips for remembering medications

Clinical pharmacist will review purpose of medications of interest (beta-blockers, statins, ACEI/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.

Device: 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.

Behavioral: 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.

Behavioral: 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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older
Utilize a pharmacy in Durham or Robeson County, NC
Have coronary artery disease documented in the medical record by one of the following:
1. A diagnosis of unstable angina or AMI (ST segment elevation or non-ST segment elevation MI)
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 the Durham or Robeson County, NC
Patient is unable to give consent (cognitively impaired, does not speak English, or has altered mental status)
Patient transferred to CT 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 or Robeson County pharmacy throughout the study period

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323258

Contacts

Contact: Sara B Calvert, PharmD

919-668-7540

sara.calvert@duke.edu

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27704
Contact: Sara B Calvert, PharmD 919-668-7540 sara.calvert@duke.edu
Principal Investigator: Judith M Kramer, MD, MS

Sponsors and Collaborators

Duke University

Pfizer

Agency for Healthcare Research and Quality (AHRQ)

Investigators

Principal Investigator:	Judith M. Kramer, MD,MS	Duke University
Principal Investigator:	Nancy Allen LaPointe, PharmD	Duke University

More Information

Additional Information:

Click here for more information about the Duke CERTs Research Center This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Duke University Medical Center ( Judith M. Kramer, MD, MS/Associate Professor of Medicine )
Study ID Numbers:	U18HS10548/HS/AHRQ
Study First Received:	May 5, 2006
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00323258 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Heart disease
Coronary disease
Patient compliance
Treatment refusal
Pharmacists

Continuity of patient care
Evidence-based medicine
Patient education
Adherence

Study placed in the following topic categories:

Disulfiram
Coronary Disease
Heart Diseases
Aspirin

Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coronary Artery Disease

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009