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Outcomes Study of MTM in a Medicare ACO

Primary Purpose

Pain, Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MTM
Sponsored by
HealthEast Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain focused on measuring blood coagulation

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • HealthEast Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MTM

Control

Arm Description

Patients will receive MTM at an individualized frequency for 1 year.

Patients enrolled in the control group will not experience any change in their medical care.

Outcomes

Primary Outcome Measures

Hospitalization Rates
Emergency Department Visits

Secondary Outcome Measures

Full Information

First Posted
August 15, 2016
Last Updated
February 23, 2018
Sponsor
HealthEast Care System
Collaborators
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02875925
Brief Title
Outcomes Study of MTM in a Medicare ACO
Official Title
Pharmacist-provided Medication Management in Medicare-ACO Patients Taking Medications Associated With Medication-related Hospitalization or Emergency Visits in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthEast Care System
Collaborators
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hypoglycemia
Keywords
blood coagulation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MTM
Arm Type
Experimental
Arm Description
Patients will receive MTM at an individualized frequency for 1 year.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients enrolled in the control group will not experience any change in their medical care.
Intervention Type
Other
Intervention Name(s)
MTM
Other Intervention Name(s)
Medication Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospitalization Rates
Time Frame
12 months
Title
Emergency Department Visits
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Wallace, PharmD, MS
Organizational Affiliation
HealthEast Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthEast Care System
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Outcomes Study of MTM in a Medicare ACO

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