PainNCT02875925
Outcomes Study of MTM in a Medicare ACO
A study testing MTM in people with Pain and Hypoglycemia, run by HealthEast Care System at 1 site in United States.
Trial summary
This is a non-randomized, prospective, quasi-experimental study designed to assess the impact of pharmacist-provided medication management on total cost of care and clinical outcomes (ie, hospitalizations, emergency department visits) in a real-world clinical practice. Read more about this study
- Who is it for?
- Ages 66 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Hypoglycemia
- What is being tested?
- MTM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2017
- 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 66 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- MSSP patient, attributed to Community Health Network
- Receive primary care at HealthEast as demonstrated by having > 2 outpatient visits at one of HealthEast's primary care clinics in the 3 years prior to enrollment.
- Currently taking > 1 medication from the following therapeutic classes: antiplatelet/anticoagulant, hypoglycemic (oral or insulin), opioid analgesic
- Willingness of subject to work with a MTM pharmacist for medication management throughout the 12 month study period.
- Provided written informed consent
Who cannot join
- Currently receiving their primary care at a non-HealthEast clinic
- Inpatient status at Bethesda Hospital within last 12 months
- Currently receiving hospice care
- In the opinion of the investigator, have any kind of disorder that may compromise the ability of the subject to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacist-provided Medication Management in Medicare-ACO Patients Taking Medications Associated With Medication-related Hospitalization or Emergency Visits in the Elderly
This is a non-randomized, prospective, quasi-experimental study designed to assess the impact of pharmacist-provided medication management on total cost of care and clinical outcomes (ie, hospitalizations, emergency department visits) in a real-world clinical practice.
Read the detailed description
Medication Management (MTM)
Medication management is defined as the standard of care that ensures each patient's medications, including prescription, over-the-counter, herbal products, vitamins, and supplements, are individually assessed to determine the following:
- Appropriateness of each medication for the patient
- Effectiveness for the patient's medical conditions
- Safety given the patient's co-morbidities and other medications
- Convenience to be taken by the patient as intended
Medication management services are delivered to an individual patient and are fully integrated with the health care team to achieve coordinated and consistent patient care. Pharmacists provide this service using a standardized method to comprehensively review each patient's medications. This systematic process is designed to identify, prevent, and resolve drug therapy problems and to aid in attainment of a patient's therapy goals. Medication management services include an individualized care plan that tracks progress on the intended goals of therapy with appropriate follow-up to determine actual patient outcomes. Pharmacists aim to emphasize the care experience for patients, achieve better medication-related quality measures, and reduce the cost of care.
Patients who are enrolled in the MTM group will have an initial MTM visit, which will last approximately 60 minutes. In this visit, the patient and the pharmacist will discuss all medications (prescription, over-the-counter, and herbal) that the patient is taking. Medications will be evaluated for indication, efficacy, safety and convenience. The pharmacist and patient and other care team members will participate in shared decision in an effort to optimize patient clinical outcomes and medication experience. Patients will continue to work with their primary care provider and other care team members. Patients will continue to meet with the pharmacist on an individualized basis for 1 year to optimize the patients' medications based on individual needs.
Patients enrolled in the control group will not experience any change in their medical care on account of being enrolled in the control group. They will continue to work with their primary care provider and other care team members.
- Conditions
- Pain, Hypoglycemia
- Being tested
- MTM
- Keywords
- blood coagulation
- Medical subject headings
- Pain, Hypoglycemia, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTMOther
Also called Medication Management
Medication management is a process that ensures each patient's medications are assessed to determine the appropriateness, effectiveness, safety, and convenience of each medication for the patient. Medication management is fully integrated with the care team. Pharmacists provide this service to identify, prevent, and resolve drug therapy problems improve outcomes.
| Study group | Role | What they receive |
|---|---|---|
| MTM | Experimental | Patients will receive MTM at an individualized frequency for 1 year. Receives: Other: MTM |
| Control | No intervention | Patients enrolled in the control group will not experience any change in their medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization Rates
Measured: 12 months
Emergency Department Visits
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthEast Care System
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Margaret Wallace, PharmD, MS, Principal investigator, HealthEast Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875925
- Sponsor's protocol ID
- MSSMMTM1
- Status last verified
- Jun 2017
- First submitted
- 15 Aug 2016
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-provided Medication Management in Medicare-ACO Patients Taking Medications Associated With Medication-related Hospitalization or Emergency Visits in the Elderly
- ClinicalTrials.gov ID
- NCT02875925
- Acronym / sponsor ID
- MSSMMTM1
- Conditions
- Pain, Hypoglycemia
- Keywords
- blood coagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- HealthEast Care SystemUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Aug 2016 (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.
This is a non-randomized, prospective, quasi-experimental study designed to assess the impact of pharmacist-provided medication management on total cost of care and clinical outcomes (ie, hospitalizations, emergency department visits) in a real-world clinical practice.
Detailed description
Medication Management (MTM)
Medication management is defined as the standard of care that ensures each patient's medications, including prescription, over-the-counter, herbal products, vitamins, and supplements, are individually assessed to determine the following:
- Appropriateness of each medication for the patient
- Effectiveness for the patient's medical conditions
- Safety given the patient's co-morbidities and other medications
- Convenience to be taken by the patient as intended
Medication management services are delivered to an individual patient and are fully integrated with the health care team to achieve coordinated and consistent patient care. Pharmacists provide this service using a standardized method to comprehensively review each patient's medications. This systematic process is designed to identify, prevent, and resolve drug therapy problems and to aid in attainment of a patient's therapy goals. Medication management services include an individualized care plan that tracks progress on the intended goals of therapy with appropriate follow-up to determine actual patient outcomes. Pharmacists aim to emphasize the care experience for patients, achieve better medication-related quality measures, and reduce the cost of care.
Patients who are enrolled in the MTM group will have an initial MTM visit, which will last approximately 60 minutes. In this visit, the patient and the pharmacist will discuss all medications (prescription, over-the-counter, and herbal) that the patient is taking. Medications will be evaluated for indication, efficacy, safety and convenience. The pharmacist and patient and other care team members will participate in shared decision in an effort to optimize patient clinical outcomes and medication experience. Patients will continue to work with their primary care provider and other care team members. Patients will continue to meet with the pharmacist on an individualized basis for 1 year to optimize the patients' medications based on individual needs.
Patients enrolled in the control group will not experience any change in their medical care on account of being enrolled in the control group. They will continue to work with their primary care provider and other care team members.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTM | Experimental | Other: MTMPatients will receive MTM at an individualized frequency for 1 year. |
| Control | No intervention | –Patients enrolled in the control group will not experience any change in their medical care. |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- MSSP patient, attributed to Community Health Network
- Receive primary care at HealthEast as demonstrated by having > 2 outpatient visits at one of HealthEast's primary care clinics in the 3 years prior to enrollment.
- Currently taking > 1 medication from the following therapeutic classes: antiplatelet/anticoagulant, hypoglycemic (oral or insulin), opioid analgesic
- Willingness of subject to work with a MTM pharmacist for medication management throughout the 12 month study period.
- Provided written informed consent
Key exclusion criteria (4 listed)
- Currently receiving their primary care at a non-HealthEast clinic
- Inpatient status at Bethesda Hospital within last 12 months
- Currently receiving hospice care
- In the opinion of the investigator, have any kind of disorder that may compromise the ability of the subject to provide 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 |
|---|---|---|
| MTMAlso: Medication ManagementMedication management is a process that ensures each patient's medications are assessed to determine the appropriateness, effectiveness, safety, and convenience of each medication for the patient. Medication management is fully integrated with the care team. Pharmacists provide this service to identify, prevent, and resolve drug therapy problems improve outcomes. | Other | MTM |
Primary outcome
Hospitalization Rates
Time frame: 12 months
Emergency Department Visits
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: Yes
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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.
Margaret Wallace, PharmD, MS principal investigator
HealthEast Care 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 MTM in people with Pain and Hypoglycemia, run by HealthEast Care System 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 27 Feb 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization Rates (time frame: 12 months). The study lists 2 primary outcomes in all. 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 27 Feb 2018.