Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes

NCT00399880 | Completed Results

• 2 other identifiers: 00000116K23HL077597
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome (ACS)

Keywords

Clinical Trial; Behavioral/Social; Cardiovascular Disease; Risk Factors/Analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Self-Efficacy for Appropriate Medication Use Scale (SEAMS)

  Approximately 2 weeks after hospital discharge

Study Arms (2)

Health literacy intervention

EXPERIMENTAL

Illustrated medication schedules, pill boxes, pharmacist counseling

Behavioral: Health literacy intervention

Usual care

NO INTERVENTION

Interventions

Health literacy intervention BEHAVIORAL

Illustrated medication schedules, pill boxes, pharmacist counseling

Health literacy intervention

Eligibility Criteria

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

You may qualify if:

• \- 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:
• EKG changes in ≥ 2 contiguous leads shown by:
• \* Transient (\< 30 min) ST-segment elevation of ≥ 1.0mm
• \* Transient or persistent ST-segment depression of ≥ 0.5mm (flat or downsloping at the J-point and at 80ms after the J-point)
• \* Persistent T-wave inversion of ≥ 2.0mm
• Abnormal elevation of cardiac enzymes
• \* Elevation of creating kinase (CK) and creatine kinase-myocardial band (CK-MB)
• \* Elevation of troponin

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• American Society of Health-System Pharmacists Research and Education Foundation: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Behavior; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Results Point of Contact

• Title: Kathryn Goggins, Research Coordinator
• Organization: Vanderbilt University Medical Center

Kathryn.m.goggins@vanderbilt.edu

6159364819

Study Officials

• Sunil Kripalani, MD, MSc

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 15, 2006
• Study Start: November 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 25, 2017
• Results First Posted: September 25, 2017

Record last verified: 2017-07

Locations

US (1)