Coronary Heart DiseaseMUMPSNCT01427218
Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease
A study testing Titration of medications, Lifestyle Counseling and Medication Counseling in people with Coronary Heart Disease and Myocardial Infarction, run by Middle Tennessee Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Coronary Heart Disease, Myocardial Infarction
- What is being tested?
- Titration of medications, Lifestyle Counseling and Medication Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Tennessee Valley Healthcare System
Nashville, Tennessee, 37212
Cassandra D Benge, PharmD
About this study
Official title: A Prospective Evaluation of a Medication Therapy Management Clinic Versus Usual Medical Care in Patients Post Acute Coronary Syndrome: The MUMPS Study
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.
Read the 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.
- Conditions
- Coronary Heart Disease, Myocardial Infarction
- Being tested
- Titration of medications, Lifestyle Counseling, Medication Counseling, Usual Care with Medication Reconciliation
- Keywords
- pharmacist, medication therapy management, evidence based medicine
- Medical subject headings
- Coronary Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titration of medicationsOther
Also called Medication Therapy Management
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).
Lifestyle CounselingBehavioural
Also called Medication Therapy Management
The pharmacist will provide counseling on diet modification, smoking cessation, and physical activity
Medication CounselingBehavioural
Also called Medication Therapy Management
The pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring.
Usual Care with Medication ReconciliationOther
Also called Usual Physician Care
A medication history and assessment of adherence will be completed by the pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Medication Therapy Management (MTM) | Experimental | 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. Receives: Other: Titration of medications; Behavioral: Lifestyle Counseling; Behavioral: Medication Counseling |
| Usual Care | Placebo comparator | 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). Receives: Other: Usual Care with Medication Reconciliation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28-32 weeks after enrollment (final study visit)
Secondary outcomes (3)
Composite cardiovascular morbidity and all-cause mortality
A between group comparison of all cause mortality or VA cardiovascular readmission.
Measured: 6-9 weeks and 28-32 weeks after enrollment
Patient Satisfaction with Clinical Pharmacist Services
A descriptive analysis to assess patients' feelings about the pharmacist being involved in their CHD care
Measured: 28-32 weeks
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.
Measured: 6-9 weeks and 28-32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle Tennessee Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Health-System Pharmacists Research and Education Foundation
- Responsible party
- Principal investigator, James A S Muldowney, III MD, Middle Tennessee Research Institute
- Investigators
- James AS Muldowney, III, MD, Principal investigator, VA Tennessee Valley Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427218
- Sponsor's protocol ID
- 2010100590
- Acronym
- MUMPS
- Status last verified
- Aug 2011
- First submitted
- 14 Jan 2011
- Last updated
- 1 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of a Medication Therapy Management Clinic Versus Usual Medical Care in Patients Post Acute Coronary Syndrome: The MUMPS Study
- ClinicalTrials.gov ID
- NCT01427218
- Acronym / sponsor ID
- MUMPS / 2010100590
- Conditions
- Coronary Heart Disease, Myocardial Infarction
- Keywords
- pharmacist, medication therapy management, evidence based medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Middle Tennessee Research InstituteUniversity, hospital or other
- Collaborators
- American Society of Health-System Pharmacists Research and Education Foundation
- Study start
- Nov 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication Therapy Management (MTM) | Experimental | Other: Titration of medications, Behavioral: Lifestyle Counseling, Behavioral: Medication CounselingMedication 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. |
| Usual Care | Placebo comparator | Other: Usual Care with Medication ReconciliationVisits 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). |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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):
- AND
- are enrolled or will be enrolled in outpatient cardiovascular services at the VA Tennessee Valley Healthcare System
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titration of medicationsAlso: Medication Therapy ManagementTitration 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 | Medication Therapy Management (MTM) |
| Lifestyle CounselingAlso: Medication Therapy ManagementThe pharmacist will provide counseling on diet modification, smoking cessation, and physical activity | Behavioural | Medication Therapy Management (MTM) |
| Medication CounselingAlso: Medication Therapy ManagementThe pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring. | Behavioural | Medication Therapy Management (MTM) |
| Usual Care with Medication ReconciliationAlso: Usual Physician CareA medication history and assessment of adherence will be completed by the pharmacist. | Other | Usual Care |
Primary outcome
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).
3 secondary outcomes
Composite cardiovascular morbidity and all-cause mortality
Time frame: 6-9 weeks and 28-32 weeks after enrollment
Patient Satisfaction with Clinical Pharmacist Services
Time frame: 28-32 weeks
Change in Adherence with 8-item Morisky Adherence Tool
Time frame: 6-9 weeks and 28-32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James AS Muldowney, III, MD principal investigator
VA Tennessee Valley Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titration of medications, Lifestyle Counseling and Medication Counseling in people with Coronary Heart Disease and Myocardial Infarction, run by Middle Tennessee Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cassandra D Benge, PharmD (615-873-6019, cassandra.benge2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients at guideline goal for both blood pressure and lipids (time frame: 28-32 weeks after enrollment (final study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2011.