Trial record 9 of 11 for:    Open Studies | "Mumps"

Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease (MUMPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Middle Tennessee Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Society of Health-System Pharmacists Research and Education Foundation
Information provided by (Responsible Party):
James A S Muldowney, III MD, Middle Tennessee Research Institute
ClinicalTrials.gov Identifier:
NCT01427218
First received: January 14, 2011
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Myocardial Infarction
Other: Titration of medications
Behavioral: Lifestyle Counseling
Behavioral: Medication Counseling
Other: Usual Care with Medication Reconciliation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Middle Tennessee Research Institute:

Primary Outcome Measures:
  • Percentage of patients at guideline goal for both blood pressure and lipids [ Time Frame: 28-32 weeks after enrollment (final study visit) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Composite cardiovascular morbidity and all-cause mortality [ Time Frame: 6-9 weeks and 28-32 weeks after enrollment ] [ Designated as safety issue: No ]
    A between group comparison of all cause mortality or VA cardiovascular readmission.

  • Patient Satisfaction with Clinical Pharmacist Services [ Time Frame: 28-32 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A within group comparison of the adherence score to determine if the relationship with the pharmacist may assist with (subjective) adherence with antihypertensive therapy.


Estimated Enrollment: 170
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Management
Behavioral: Lifestyle Counseling
The pharmacist will provide counseling on diet modification, smoking cessation, and physical activity
Other Name: Medication Therapy Management
Behavioral: 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

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

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427218

Contacts
Contact: Cassandra D Benge, PharmD 615-873-6019 cassandra.benge2@va.gov
Contact: M. Shawn McFarland, PharmD 615-867-6000 ext 24796 michael.mcfarland2@va.gov

Locations
United States, Tennessee
VA Tennessee Valley Healthcare System Recruiting
Nashville, Tennessee, United States, 37212
Sub-Investigator: Cassandra D Benge, PharmD         
Sponsors and Collaborators
Middle Tennessee Research Institute
American Society of Health-System Pharmacists Research and Education Foundation
Investigators
Principal Investigator: James AS Muldowney, III, MD VA Tennessee Valley Healthcare System
  More Information

No publications provided

Responsible Party: James A S Muldowney, III MD, Assistant Professor of Medicine, Vanderbilt Univ. School of Med, Middle Tennessee Research Institute
ClinicalTrials.gov Identifier: NCT01427218     History of Changes
Other Study ID Numbers: 2010100590
Study First Received: January 14, 2011
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Middle Tennessee Research Institute:
pharmacist
medication therapy management
evidence based medicine

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014