- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01427218
Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease (MUMPS)
A Prospective Evaluation of a Medication Therapy Management Clinic Versus Usual Medical Care in Patients Post Acute Coronary Syndrome: The MUMPS Study
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cassandra D Benge, PharmD
- Phone Number: 615-873-6019
- Email: cassandra.benge2@va.gov
Study Contact Backup
- Name: M. Shawn McFarland, PharmD
- Phone Number: 24796 615-867-6000
- Email: michael.mcfarland2@va.gov
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37212
- Recruiting
- VA Tennessee Valley Healthcare System
-
Sub-Investigator:
- Cassandra D Benge, PharmD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
The pharmacist will provide counseling on diet modification, smoking cessation, and physical activity
Other Names:
The pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring.
Other Names:
|
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).
|
A medication history and assessment of adherence will be completed by the pharmacist.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
28-32 weeks after enrollment (final study visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite cardiovascular morbidity and all-cause mortality
Time Frame: 6-9 weeks and 28-32 weeks after enrollment
|
A between group comparison of all cause mortality or VA cardiovascular readmission.
|
6-9 weeks and 28-32 weeks after enrollment
|
Patient Satisfaction with Clinical Pharmacist Services
Time Frame: 28-32 weeks
|
A descriptive analysis to assess patients' feelings about the pharmacist being involved in their CHD care
|
28-32 weeks
|
Change in Adherence with 8-item Morisky Adherence Tool
Time Frame: 6-9 weeks and 28-32 weeks
|
A within group comparison of the adherence score to determine if the relationship with the pharmacist may assist with (subjective) adherence with antihypertensive therapy.
|
6-9 weeks and 28-32 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: James AS Muldowney, III, MD, VA Tennessee Valley Healthcare System
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010100590
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
Clinical Trials on Titration of medications
-
University Hospital, AntwerpCompletedObstructive Sleep ApneaBelgium
-
The Cleveland ClinicThe Huron FoundationCompletedMedication Adherence | Medication Compliance
-
Sichuan Provincial People's HospitalNot yet recruitingUnrecognized ConditionChina
-
University of CalgaryAlberta Children's Hospital; Masimo Corp - Equipment loan; Datex Ohmeda - Equipment...CompletedPrematurity | Respiratory Distress | Oxidative InjuryCanada
-
University of CalgaryEquipment loan from Masimo Corp.CompletedPrematurity | Oxidative Pulmonary InjuryCanada
-
Sociedad Española de Neumología y Cirugía TorácicaCompletedObesity Hypoventilation Syndrome | Chronic Hypercapnic Respiratory FailureSpain
-
Rigshospitalet, DenmarkAbbVieCompleted
-
Hospital Italiano de Buenos AiresCompletedAcute Respiratory Distress Syndrome | Capnography
-
Southeast University, ChinaCompletedAcute Exacerbation Chronic Obstructive Pulmonary DiseaseChina
-
Amsterdam UMC, location VUmcCompletedCritical Illness | Muscle Weakness | Respiration, Artificial | Muscle Damage | Respiratory, DiaphragmNetherlands