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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome (ACS)
• Intervention / Treatment: Behavioral: Health literacy intervention

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Health literacy intervention; Illustrated medication schedules, pill boxes, pharmacist counseling	Behavioral: Health literacy intervention; Illustrated medication schedules, pill boxes, pharmacist counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Refills and Medications Scale (ARMS)	Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.	Approximately 2 weeks after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy for Appropriate Medication Use Scale (SEAMS)	Validated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence.	Approximately 2 weeks after hospital discharge

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); American Society of Health-System Pharmacists Research and Education Foundation
• Investigators: Principal Investigator: Sunil Kripalani, MD, MSc, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: November 13, 2006
• First Submitted That Met QC Criteria: November 13, 2006
• First Posted (Estimate): November 15, 2006

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Clinical Trial; Behavioral/Social; Risk Factors/Analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 00000116; K23HL077597 (U.S. NIH Grant/Contract)