Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease (MUMPS)
|ClinicalTrials.gov Identifier: NCT01427218|
Recruitment Status : Unknown
Verified August 2011 by James A S Muldowney, III MD, Middle Tennessee Research Institute.
Recruitment status was: Recruiting
First Posted : September 1, 2011
Last Update Posted : September 1, 2011
|Condition or disease||Intervention/treatment|
|Coronary Heart Disease Myocardial Infarction||Other: Titration of medications Behavioral: Lifestyle Counseling Behavioral: Medication Counseling Other: Usual Care with Medication Reconciliation|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Prospective Evaluation of a Medication Therapy Management Clinic Versus Usual Medical Care in Patients Post Acute Coronary Syndrome: The MUMPS Study|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||December 2012|
Experimental: 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.
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).
Other Name: Medication Therapy ManagementBehavioral: Lifestyle Counseling
The pharmacist will provide counseling on diet modification, smoking cessation, and physical activity
Other Name: Medication Therapy ManagementBehavioral: Medication Counseling
The pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring.
Other Name: Medication Therapy Management
Placebo Comparator: Usual Care
Visits 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).
Other: Usual Care with Medication Reconciliation
A medication history and assessment of adherence will be completed by the pharmacist.
Other Name: Usual Physician Care
- Percentage of patients at guideline goal for both blood pressure and lipids [ Time Frame: 28-32 weeks after enrollment (final study visit) ]The Primary endpoint is the percentage of patients in each group who have BOTH their lipids AND their BP controlled within guideline specifications at the end of the study in order to determine if the clinic improves control of BOTH of these risk factors. (e.g. on the final study visit, 75% in the intervention arm and 50% in the control arm have controlled lipids AND blood pressure, given the I/E criteria, both groups start out at 0% at entry).
- Composite cardiovascular morbidity and all-cause mortality [ Time Frame: 6-9 weeks and 28-32 weeks after enrollment ]A between group comparison of all cause mortality or VA cardiovascular readmission.
- Patient Satisfaction with Clinical Pharmacist Services [ Time Frame: 28-32 weeks ]A descriptive analysis to assess patients' feelings about the pharmacist being involved in their CHD care
- Change in Adherence with 8-item Morisky Adherence Tool [ Time Frame: 6-9 weeks and 28-32 weeks ]A within group comparison of the adherence score to determine if the relationship with the pharmacist may assist with (subjective) adherence with antihypertensive therapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427218
|Contact: Cassandra D Benge, PharmDfirstname.lastname@example.org|
|Contact: M. Shawn McFarland, PharmD||615-867-6000 ext email@example.com|
|United States, Tennessee|
|VA Tennessee Valley Healthcare System||Recruiting|
|Nashville, Tennessee, United States, 37212|
|Sub-Investigator: Cassandra D Benge, PharmD|
|Principal Investigator:||James AS Muldowney, III, MD||VA Tennessee Valley Healthcare System|