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

Primary Purpose

Coronary Heart Disease, Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Titration of medications
Lifestyle Counseling
Medication Counseling
Usual Care with Medication Reconciliation
Sponsored by
Middle Tennessee Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Heart Disease focused on measuring pharmacist, medication therapy management, evidence based medicine

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Tennessee Valley Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Medication Therapy Management (MTM)

Usual Care

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Percentage of patients at guideline goal for both blood pressure and lipids
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
A between group comparison of all cause mortality or VA cardiovascular readmission.
Patient Satisfaction with Clinical Pharmacist Services
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
A within group comparison of the adherence score to determine if the relationship with the pharmacist may assist with (subjective) adherence with antihypertensive therapy.

Full Information

First Posted
January 14, 2011
Last Updated
August 31, 2011
Sponsor
Middle Tennessee Research Institute
Collaborators
American Society of Health-System Pharmacists Research and Education Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01427218
Brief Title
Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease
Acronym
MUMPS
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

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Middle Tennessee Research Institute
Collaborators
American Society of Health-System Pharmacists Research and Education Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Myocardial Infarction
Keywords
pharmacist, medication therapy management, evidence based medicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medication Therapy Management (MTM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Titration of medications
Other Intervention Name(s)
Medication Therapy Management
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling
Other Intervention Name(s)
Medication Therapy Management
Intervention Description
The pharmacist will provide counseling on diet modification, smoking cessation, and physical activity
Intervention Type
Behavioral
Intervention Name(s)
Medication Counseling
Other Intervention Name(s)
Medication Therapy Management
Intervention Description
The pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring.
Intervention Type
Other
Intervention Name(s)
Usual Care with Medication Reconciliation
Other Intervention Name(s)
Usual Physician Care
Intervention Description
A medication history and assessment of adherence will be completed by the pharmacist.
Primary Outcome Measure Information:
Title
Percentage of patients at guideline goal for both blood pressure and lipids
Description
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).
Time Frame
28-32 weeks after enrollment (final study visit)
Secondary Outcome Measure Information:
Title
Composite cardiovascular morbidity and all-cause mortality
Description
A between group comparison of all cause mortality or VA cardiovascular readmission.
Time Frame
6-9 weeks and 28-32 weeks after enrollment
Title
Patient Satisfaction with Clinical Pharmacist Services
Description
A descriptive analysis to assess patients' feelings about the pharmacist being involved in their CHD care
Time Frame
28-32 weeks
Title
Change in Adherence with 8-item Morisky Adherence Tool
Description
A within group comparison of the adherence score to determine if the relationship with the pharmacist may assist with (subjective) adherence with antihypertensive therapy.
Time Frame
6-9 weeks and 28-32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. are enrolled or will be enrolled in outpatient cardiovascular services at the VA Tennessee Valley Healthcare System Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassandra D Benge, PharmD
Phone
615-873-6019
Email
cassandra.benge2@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
M. Shawn McFarland, PharmD
Phone
615-867-6000
Ext
24796
Email
michael.mcfarland2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James AS Muldowney, III, MD
Organizational Affiliation
VA Tennessee Valley Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Tennessee Valley Healthcare System
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassandra D Benge, PharmD

12. IPD Sharing Statement

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Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease

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