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

NCT00323258 | Completed Results

• 2 other identifiers: Pro00005018U18HS010548
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Heart disease; Coronary disease; Patient compliance; Treatment refusal; Pharmacists; Continuity of patient care; Evidence-based medicine; Patient education; Adherence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records

  6 months

• Percent of Patients Adherent to Beta-blocker Via Refill Records

  6 months

• Percent of Patients Adherent to Statin Via Refill Records

  6 months

• Death in Intervention Patients Compared to Usual Care

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

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

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Routine discharge counseling; Other: Letter to physician/discharge summary

Interventions

oral education & written tips for remembering medications BEHAVIORAL

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.

Also known as: Cue-dose training

Intervention

pill box DEVICE

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

Also known as: Pill box organizer, pillbox

Intervention

pocket medication card DEVICE

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.

Also known as: Medication List, List of Medications

Intervention

sharing information with community pharmacist BEHAVIORAL

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.

Also known as: increased communication with community pharmacist

Intervention

Medication use evaluations by community pharmacist BEHAVIORAL

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.

Also known as: medcation adherence verification

Intervention

informing physician if patient has stopped a medication BEHAVIORAL

The community pharmacist or clinical pharmacist-investigator will fax the subject's physician to notify that a medication has been stopped.

Also known as: Communication with physician about patient's medication use

Intervention

Routine discharge counseling BEHAVIORAL

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

Also known as: Discharge instructions

Intervention; Usual Care

Letter to physician/discharge summary OTHER

A letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations.

Also known as: Communication to physician about hospital course.

Intervention; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Pfizer: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27704, United States

Location

Related Publications (2)

• 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.

  PMID: 16401776 BACKGROUND

• 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.

  PMID: 22520532 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Coronary Disease; Patient Compliance; Treatment Refusal

Interventions

Educational Status; Pharmacists

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Sara Calvert, PharmD
• Organization: Duke University Medical Center

sara.calvert@duke.edu

919-668-7540

Study Officials

• Judith M. Kramer, MD,MS

  Duke University

  PRINCIPAL INVESTIGATOR

• Nancy Allen LaPointe, PharmD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: June 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2011
• Last Updated: January 18, 2013
• Results First Posted: April 19, 2012

Record last verified: 2012-05

Locations

US (1)