Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes (IMAGE-ACS)

This study has been completed.
Sponsor:
Collaborators:
American Society of Health-System Pharmacists Research and Education Foundation
Information provided by (Responsible Party):
Sunil Kripalani, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00399880
First received: November 13, 2006
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

Coronary heart disease (CHD) is the leading cause of death in the United States. Most people who die from CHD die of a heart attack. Acute coronary syndrome (ACS) is a term that includes mild heart attacks, as well as other episodes of chest pain that may serve as a warning sign for an upcoming heart attack.

There are many medicines that can help prevent and treat ACS. However, at least 25% of patients don't take their medications as prescribed. When patients don't take their medications, we say they are noncompliant or nonadherent with the treatment.

The period following hospital discharge is a vulnerable time for many patients. Patients are often confused about what to do when they return home from the hospital. Many patients don't take their medications correctly, or they don't take them at all. Patients with poor literacy skills have more trouble than others, because it is harder for them to follow written instructions. Overall, about half of the adults in the U.S. have poor literacy skills. It is important to develop ways to help these adults manage their health better.

The purposes of this research project are 1) to learn more about the relationship between low literacy and medication adherence after hospital discharge, and 2) to test a strategy designed to help patients take their medicines more regularly. We will recruit consenting patients hospitalized with ACS. We will measure their literacy skills, ask questions about how they take their medicines, and measure other related factors like social support and self-efficacy. Patients will then be assigned to 1 of 2 groups. One group will receive only usual care at hospital discharge, which usually includes the nurse and physician briefly reviewing the medication prescriptions. The other group will receive an illustrated daily medication schedule and special, tailored counseling from a pharmacist at their time of discharge. About 1 week after patients leave the hospital we will contact them by phone to ask them questions about how they have been taking their medicines. We will get data from patients records for 6 months to see if the intervention had an impact on their medication compliance, blood pressure, cholesterol, and diabetes measurements.

If this study is successful, this simple strategy could be implemented by hospitals to improve medication compliance after discharge. This study will also provide more information about how patients' literacy skills affect their medication compliance.


Condition Intervention
Acute Coronary Syndrome (ACS)
Behavioral: Health literacy intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Medication adherence [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
    Self-reported medication adherence


Secondary Outcome Measures:
  • Medication self-efficacy [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: November 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health literacy intervention
Illustrated medication schedules, pill boxes, pharmacist counseling
Behavioral: Health literacy intervention
Illustrated medication schedules, pill boxes, pharmacist counseling
No Intervention: Usual care

  Eligibility

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

Inclusion Criteria:

- Present with acute chest pain or angina equivalent, lasting ≥ 10 minutes of suspected ischemic origin, within the previous 24 hours of presentation to the hospital.

PLUS

  • Patient must have documented objective evidence of myocardial ischemia based on a or b:

    1. EKG changes in ≥ 2 contiguous leads shown by:

      * Transient (< 30 min) ST-segment elevation of ≥ 1.0mm

      OR

      * Transient or persistent ST-segment depression of ≥ 0.5mm (flat or downsloping at the J-point and at 80ms after the J-point)

      OR

      * Persistent T-wave inversion of ≥ 2.0mm

    2. Abnormal elevation of cardiac enzymes

      * Elevation of creating kinase (CK) and creatine kinase-myocardial band (CK-MB)

      OR

      * Elevation of troponin

      Exclusion Criteria:

  • Previously enrolled in the study
  • Police custody
  • Corrected visual acuity worse than 20/60
  • Lack of cooperation
  • Severe hearing impairment
  • Too ill to participate
  • Unintelligible speech
  • Age younger than 18 years
  • Native language other than English
  • Psychotic illness
  • Caregiver administers all medications
  • Delirium/severe dementia
  • Does not fill prescriptions at Grady
  • No regular telephone/address
  • Not taking chronic medications prior to admission
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399880

Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Vanderbilt University
American Society of Health-System Pharmacists Research and Education Foundation
Investigators
Principal Investigator: Sunil Kripalani, MD, MSc Vanderbilt University
  More Information

No publications provided

Responsible Party: Sunil Kripalani, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00399880     History of Changes
Other Study ID Numbers: 00000116, K23HL077597
Study First Received: November 13, 2006
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Clinical Trial
Behavioral/Social
Cardiovascular Disease
Risk Factors/Analysis

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014