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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00426231
Recruitment Status : Completed
First Posted : January 24, 2007
Results First Posted : February 24, 2014
Last Update Posted : February 24, 2014
Information provided by (Responsible Party):
Dhananjay Vaidya, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Myocardial Infarction Behavioral: Navigation by a health worker Behavioral: Information control Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Culturally-Tailored Hospital-based Model to Improve Statin Use and Outcomes in Patients With Coronary Disease
Study Start Date : March 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Patient Navigator intervention
Patient Navigator intervention
Behavioral: Navigation by a health worker
Help provided by health worker to navigate medication access programs

Active Comparator: Information control
Information control
Behavioral: Information control
Information about medication access programs provided to the participant and their healthcare provider
Other Name: Enhanced usual care

Primary Outcome Measures :
  1. Achievement of LDL-cholesterol Goals [ Time Frame: 6 months ]
    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.

Secondary Outcome Measures :
  1. Self-reported Medication Adherence [ Time Frame: 6 months ]
    Only individuals with 6-month follow-up data were included in this analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00426231

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Dhananjay Vaidya, MBBS PhD MPH Johns Hopkins University

Responsible Party: Dhananjay Vaidya, Associate Professor of Medicine, Johns Hopkins University Identifier: NCT00426231     History of Changes
Other Study ID Numbers: NA_00001948
AHA 0670015N
First Posted: January 24, 2007    Key Record Dates
Results First Posted: February 24, 2014
Last Update Posted: February 24, 2014
Last Verified: January 2014

Keywords provided by Dhananjay Vaidya, Johns Hopkins University:
Randomized Controlled Trials
Health Education
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Patient Nonadherence

Additional relevant MeSH terms:
Myocardial Infarction
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Coronary Disease
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents