Outcomes Study of MTM in a Medicare ACO

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.

Study Overview

• Status: Completed
• Conditions: Pain; Hypoglycemia
• Intervention / Treatment: Other: MTM

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 Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55103
      • HealthEast Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MTM; Patients will receive MTM at an individualized frequency for 1 year.	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.; Other Names: Medication Management
No Intervention: Control; Patients enrolled in the control group will not experience any change in their medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Emergency Department Visits	12 months
Hospitalization Rates	12 months

Collaborators and Investigators

• Sponsor: HealthEast Care System
• Collaborators: University of Minnesota
• Investigators: Principal Investigator: Margaret Wallace, PharmD, MS, HealthEast Care System

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 23, 2016

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: blood coagulation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: MSSMMTM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES