Outcomes Study of MTM in a Medicare ACO

Pain Clinical Trial

Official title:

Pharmacist-provided Medication Management in Medicare-ACO Patients Taking Medications Associated With Medication-related Hospitalization or Emergency Visits in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875925
• Other study ID #: MSSMMTM1
• Status: Completed
• Phase: N/A
• First received: August 15, 2016
• Last updated: February 23, 2018
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: HealthEast Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 66 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypoglycemia
• Pain

Intervention

Other:
• MTM
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.

Locations

Country	Name	City	State
United States	HealthEast Care System	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthEast Care System	University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization Rates		12 months
Primary	Emergency Department Visits		12 months