NCT01427218

Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease

A Prospective Evaluation of a Medication Therapy Management Clinic Versus Usual Medical Care in Patients Post Acute Coronary Syndrome: The MUMPS Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Middle Tennessee Research Institute · Academic / Other
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. This is a randomized study comparing the use of a medication therapy management clinic improves cardiac risk factors and recurrent hospitalization in patients admitted with an acute coronary syndrome. 100 subjects will be enrolled as a minimum. Patients will be randomized to usual care or enrollment in the MTM clinic where they will be seen every two months for 8 months. The primary endpoint is blood pressure and lipid changes. Secondary endpoints include satisfaction with pharmacists, medication habit changes, recurrent events.

Conditions

• Coronary Heart Disease
• Myocardial Infarction

Interventions

Type	Name	Description
OTHER	Titration of medications	Titration 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 Counseling	The pharmacist will provide counseling on diet modification, smoking cessation, and physical activity
BEHAVIORAL	Medication Counseling	The pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring.
OTHER	Usual Care with Medication Reconciliation	A medication history and assessment of adherence will be completed by the pharmacist.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2011-09-01
• Last updated: 2011-09-01

Locations

1 site across 1 country: United States