A Prospective Evaluation of a Medication Therapy Management Clinic Versus Usual Medical Care in Patients Post Acute Coronary Syndrome: The MUMPS Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Percentage of patients at guideline goal for both blood pressure and lipids
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a diagnosis of ACS at the VA Tennessee Valley Healthcare System who
- •are greater than or equal to 60 years of age
- •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.
- •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.
- •are enrolled or will be enrolled in outpatient cardiovascular services at the VA Tennessee Valley Healthcare System
排除标准
- •Patients who
- •are transferred to a long-term care facility or skilled nursing facility
- •are assigned to another Veterans Health Administration medical center,
- •have a discharge primary or secondary discharge diagnosis code for dementia, schizophrenia, or organic brain syndrome,
- •cannot speak or understand English or give written informed consent,
- •are enrolled in hospice or palliative care
- •are participating in another trial that prohibits participation in this trial
- •have a baseline LDL> 200mg/dL in proximity to admission suggestive of familial hypercholesterolemia (FH) or a known diagnosis of FH
- •require clonidine or minoxidil for blood pressure control prior to the index admission
- •are enrolled in the Nashville preventative cardiovascular clinic for hypertension
- •have a urinary drug screen positive for cocaine in the last 12 months
- •have plans to move in the next 6 months
结局指标
主要结局
Percentage of patients at guideline goal for both blood pressure and lipids
时间窗: 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).
次要结局
- Composite cardiovascular morbidity and all-cause mortality(6-9 weeks and 28-32 weeks after enrollment)
- Patient Satisfaction with Clinical Pharmacist Services(28-32 weeks)
- Change in Adherence with 8-item Morisky Adherence Tool(6-9 weeks and 28-32 weeks)
研究者
James A S Muldowney, III MD
Assistant Professor of Medicine, Vanderbilt Univ. School of Med
Middle Tennessee Research Institute