Coronary Heart Disease | Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease
Coronary Heart Disease research study
What is the primary objective of this study?
Existing trials for the patient with coronary heart disease evaluate the interdisciplinary team dynamic where pharmacists (pharmacotherapists) provide therapeutic recommendations in the inpatient environment. To our knowledge, only other trial has evaluated the addition of a pharmacist (or nurse practitioner) in an outpatient collaborative cardiology practice and has found no benefit. However, the investigators believe that since a cardiology based pharmacist (pharmacotherapist) in the Veterans Health Administration has physical assessment skills, a shorter cycle length between appointments, and the ability to provide medication therapy management, the pharmacotherapist should be similarly successful as seen with other pharmacist based medication therapy management practices. The investigators will assess effectiveness by using the combined endpoint of blood pressure and lipid treatment. Additionally the investigators will conduct three substudies to evaluate if the pharmacist can improve all cause mortality and cardiovascular morbidity, adherence to antihypertensives, and patient satisfaction.
Who is eligible to participate?
Inclusion Criteria: All patients with a diagnosis of ACS at the VA Tennessee Valley Healthcare System who 1. are greater than or equal to 60 years of age 2. will benefit from Medication Therapy Management (MTM): - Have a baseline LDL >79mg/dL in the first 24 hours of acute coronary syndrome (ACS) OR if LDL not assessed in the first 24 hours of ACS, have a recent LDL >79mg/dL (in the last 15 months) OR not have an LDL assessed prior to or during admission. AND - Have outpatient blood pressures (BP) above goal on 65% or more of assessments within the last 15 months or a SBP >140mmHg or DBP>90mmHg or both on the last outpatient BP assessment. 3. are enrolled or will be enrolled in outpatient cardiovascular services at the VA Tennessee Valley Healthcare System Exclusion Criteria: Patients who 1. are transferred to a long-term care facility or skilled nursing facility 2. are assigned to another Veterans Health Administration medical center, 3. have a discharge primary or secondary discharge diagnosis code for dementia, schizophrenia, or organic brain syndrome, 4. cannot speak or understand English or give written informed consent, 5. are enrolled in hospice or palliative care 6. are participating in another trial that prohibits participation in this trial 7. have a baseline LDL> 200mg/dL in proximity to admission suggestive of familial hypercholesterolemia (FH) or a known diagnosis of FH 8. require clonidine or minoxidil for blood pressure control prior to the index admission 9. are enrolled in the Nashville preventative cardiovascular clinic for hypertension 10. have a urinary drug screen positive for cocaine in the last 12 months 11. have plans to move in the next 6 months
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Coronary Heart Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Titration of medicationsTitration of medications for cholesterol, blood pressure, heart failure, and angina will occur. Cholesterol medications will be titrated according to labs at intervals nor more frequently than every 6 weeks until target LDL reached. Blood pressure (BP) medications will be titrated no more frequently than every 1-2 weeks until target BP reached. Heart failure medications will be titrated no more frequently than every 1-2 weeks until target doses reached or clinical status goals achieved. Anginal (chest pain) medications will be titrated no more frequently than every 1-2 weeks until control of chest pain occurs. Some patients will require more titrations than other patients (titration is patient specific).
Behavioral:Lifestyle CounselingThe pharmacist will provide counseling on diet modification, smoking cessation, and physical activity
Behavioral:Medication CounselingThe pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring.
Other:Usual Care with Medication ReconciliationA medication history and assessment of adherence will be completed by the pharmacist.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Medication Therapy Management (MTM)Medication Therapy Management visits with a pharmacotherapist will occur at a minimum of 6-9 weeks, 20-24 weeks, and 28-32 weeks. Additional interim face to face and telephonic visits may be scheduled based on patient's progress with meeting treatment goals and need for follow-up physical assessment and laboratory analysis.
Usual CareVisits with a pharmacotherapist to create an accurate list of medications for those patients randomized to placebo (who receive usual care by their cardiologist and primary care provider).
Start Date: November 2010
Completed Date: December 2012
Primary Outcome: Percentage of patients at guideline goal for both blood pressure and lipids
Secondary Outcome: Composite cardiovascular morbidity and all-cause mortality
Study sponsors, principal investigator, and references
Principal Investigator: James AS Muldowney, III, MD
Lead Sponsor: Middle Tennessee Research Institute
Collaborator: American Society of Health-System Pharmacists Research and Education Foundation