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

Myocardial Infarction Clinical Trial

Official title:

Culturally-Tailored Hospital-based Model to Improve Statin Use and Outcomes in Patients With Coronary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426231
• Other study ID #: NA_00001948
• Secondary ID: AHA 0670015N
• Status: Completed
• Phase: N/A
• First received: January 23, 2007
• Last updated: January 13, 2014
• Start date: March 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Behavioral:
• Navigation by a health worker
Help provided by health worker to navigate medication access programs
• Information control
Information about medication access programs provided to the participant and their healthcare provider

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Self-reported Medication Adherence	Only individuals with 6-month follow-up data were included in this analysis	6 months	No