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N/A N=73 Randomized Prevention

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

Coronary Arteriosclerosis · Myocardial Infarction

Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Achievement of LDL-cholesterol Goals — 31; 29 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Navigation by a health worker (Behavioral); Information control (Behavioral)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
Dec 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Achievement of LDL-cholesterol Goals
31; 29
SECONDARY
Self-reported Medication Adherence
16; 19

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00426231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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