Culturally-Tailored Approach to Improve Medication Use in Patients With Heart Attacks

NCT00426231 | Completed Results

• 2 other identifiers: NA_00001948AHA 0670015N
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Our research aims to improve the use of medicines known to prevent recurrent heart attacks. In particular, we know that statin treatment is useful after heart attacks, but many patients do not use it. There are a few possible reasons for this. Patients cannot find affordable medicine. Their doctor may not prescribe the medicine after they leave the hospital. Some people may culturally mistrust using the medicine. So they may decide not to take it even if it is prescribed. We are developing a hospital based culturally attuned program to target this problem. In this program, a community health worker counsels and helps patients in accessing pharmacy assistance programs. We will test whether this program can improve appropriate statin use. We will enroll patients who have heart attacks. We will compare patients who are counseled by the community health worker with those who get the usual care at baseline and at 6 and 12 months (participants enrolled during the early phase of the recruitment will have an additional study visit at 24 months). We will test if their "bad" cholesterol levels are controlled. We will find out how regularly they have filled their questionnaire and taken the medicine. Finally, we will test if they are getting benefit from the statin treatment. We will do this using blood tests and imaging the patients' arteries with ultrasound. We will also measure how cost-effective it is for a hospital to run the program. It is our goal to develop a community health worker model that is culturally sensitive for people with cultural, educational or educational barriers. Statin use is known to benefit patients in theory; such a culturally competent program will improve health outcomes in practice. After we test it, a cost-effective program such as this can be implemented in other hospitals.

Conditions

Coronary Arteriosclerosis; Myocardial Infarction

Keywords

Randomized Controlled Trials; Health Education; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Patient Nonadherence

Outcome Measures

Primary Outcomes (1)

• Achievement of LDL-cholesterol Goals

  Achieving the goal of an LDL cholesterol level of \< 100 mg/dL. For intention to treat analysis the randomization visit status is carried forward if data are missing for the 6-month follow-up visit.

  6 months

Secondary Outcomes (1)

• Self-reported Medication Adherence

  6 months

Study Arms (2)

Patient Navigator intervention

EXPERIMENTAL

Patient Navigator intervention

Behavioral: Navigation by a health worker

Information control

ACTIVE COMPARATOR

Information control

Behavioral: Information control

Interventions

Navigation by a health worker BEHAVIORAL

Help provided by health worker to navigate medication access programs

Patient Navigator intervention

Information control BEHAVIORAL

Information about medication access programs provided to the participant and their healthcare provider

Also known as: Enhanced usual care

Information control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center
• Diagnoses of Myocardial Infarction, unstable angina, percutaneous intervention, coronary artery bypass surgery
• One of the following:
• Less than a high school education (defined as completion of the 12th grade)
• No insurance for medications with a household income of $50,000. or less
• Any difficulty in co-pay even with a household income of \>$50,000.

You may not qualify if:

• physician contraindicates statin use
• chronic glucocorticosteroid therapy
• autoimmune disease (i.e. lupus erythematosus)
• current chemotherapy or radiation
• immediate life-threatening comorbidity (i.e. HIV-AIDS, end-stage renal disease, or cancer)
• history of hepatic or renal failure
• myositis with creatine kinase (CK) elevations
• any prior adverse response to statin therapy
• statin allergy
• rhabdomyolysis
• pregnant women

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Health Education; Patient Compliance

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Adherence Interventions; Medication Adherence; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dhananjay Vaidya
• Organization: Johns Hopkins University

dvaidya1@jhmi.edu

410-6142307

Study Officials

• Dhananjay Vaidya, MBBS PhD MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 23, 2007
• First Posted: January 24, 2007
• Study Start: March 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 24, 2014
• Results First Posted: February 24, 2014

Record last verified: 2014-01

Locations

US (1)