Clinical trial NCT01427218: Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Myocardial Infarction
Keywords: pharmacist
medication therapy management
evidence based medicine
Lead sponsor: Middle Tennessee Research Institute
Sponsor class: OTHER
Collaborators: name: American Society of Health-System Pharmacists Research and Education Foundation
First posted: 2011-09-01
Enrollment: 170
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients at guideline goal for both blood pressure and lipids
timeFrame: 28-32 weeks after enrollment (final study visit)
Secondary outcomes:
measure: Composite cardiovascular morbidity and all-cause mortality
timeFrame: 6-9 weeks and 28-32 weeks after enrollment
measure: Patient Satisfaction with Clinical Pharmacist Services
timeFrame: 28-32 weeks
measure: Change in Adherence with 8-item Morisky Adherence Tool
timeFrame: 6-9 weeks and 28-32 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: VA Tennessee Valley Healthcare System
state: Tennessee
Study officials:
affiliation: VA Tennessee Valley Healthcare System
name: James AS Muldowney, III, MD
role: PRINCIPAL_INVESTIGATOR
References: