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

NCT ID: NCT00426231

Last Updated: 2014-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-12-31

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.

Detailed Description

The lipid-specific and pleiotropic benefits of statin therapy, and secondary prevention of coronary artery disease (CAD) mortality have been demonstrated. Statin therapy in particular is underutilized in both white and Black American populations who have CAD and who do not have access to therapy or who cannot afford it. Systems factors related to these findings involve a lack of continuous access to medications following hospital discharge for many Black Americans and for white Americans who do not have the ability to readily afford their medicines or who do not have the educational background to understand the importance of therapy. In many cases, there is failure by primary care physicians to continue statin therapy after discharge in patients who have poor access to therapy or who do not comply with pharmacotherapy. Patient factors include mistrust and volitional nonadherence related to beliefs and personal priorities, and a lack of education and support related to preventive therapy.

This trial will thus take place in lower income and lower educational level Black and white American patients identified at the time of hospitalization and will continue for two years after a myocardial infarction, coronary artery bypass graft, or percutaneous intervention. The overall hypothesis is that a quality of care intervention delivered to Black and white American patients with lower incomes and /or education by a culturally competent community health worker (CHW) within an existing hospital system will result in improved outcomes. The CHW will counsel patients and help them access resources, including Maryland and private pharmacy assistance programs. The specific aims are to compare the impact of a hospital-based CHW intervention versus usual care (UC) on (1) the percent who achieve LDL cholesterol goals, (2) adherence to the statin regimen, and (3) health outcomes including inflammatory markers and vascular function at 6 and 12 months after hospitalization for the premature CAD event. (Participants enrolled during the early phase of the recruitment will have an additional study visit at 24 months.) We will determine the cost of achieving the LDL-C goal in each group. Outcome measures include patient adherence (pill counts, modified Hill-Bone questionnaire), lipid parameters, hs-CRP, and brachial artery reactivity as a marker of endothelial function.

Intention to treat analyses will be used. Multivariable adjusted analysis using generalized linear models or generalized estimating equations will be used to determine the independent effect of the interventions after adjusting for covariates. A sample size of 68 subjects per group can detect hypothesized differences in the proportion of participants meeting goal levels of LDL-C with 92% power, as the primary outcome at 1 years. This proposal will demonstrate the effectiveness of a potentially generalizable model of culturally competent care that will improve the use of statin therapy and its health outcomes in Black and white Americans with documented CAD and poor access to statin pharmacotherapy.

Conditions

Coronary Arteriosclerosis; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patient Navigator intervention

Patient Navigator intervention

Group Type: EXPERIMENTAL

Navigation by a health worker

Intervention Type: BEHAVIORAL

Help provided by health worker to navigate medication access programs

Information control

Information control

Group Type: ACTIVE_COMPARATOR

Information control

Intervention Type: BEHAVIORAL

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

Interventions

Navigation by a health worker

Help provided by health worker to navigate medication access programs

Intervention Type: BEHAVIORAL

Information control

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Enhanced usual care

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Dhananjay Vaidya

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dhananjay Vaidya, MBBS PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

AHA 0670015N

Identifier Type: -

Identifier Source: secondary_id

NA_00001948

Identifier Type: -

Identifier Source: org_study_id