NCT02875925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 27, 2018

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

August 15, 2016

Last Update Submit

February 23, 2018

Conditions

Keywords

blood coagulation

Outcome Measures

Primary Outcomes (2)

  • Hospitalization Rates

    12 months

  • Emergency Department Visits

    12 months

Study Arms (2)

MTM

EXPERIMENTAL

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

Other: MTM

Control

NO INTERVENTION

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

Interventions

MTMOTHER

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.

Also known as: Medication Management
MTM

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthEast Care System

Saint Paul, Minnesota, 55103, United States

Location

MeSH Terms

Conditions

PainHypoglycemiaThrombosis

Interventions

Medication Therapy Management

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMedicare Part DInsurance, Pharmaceutical ServicesInsurance, HealthInsuranceFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsMedicarePatient Care ManagementHealth Services Administration

Study Officials

  • Margaret Wallace, PharmD, MS

    HealthEast Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 23, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 27, 2018

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Locations