Implementation Study of Enhanced Medication Therapy Management in Primary Care Practice (EMTM)

October 14, 2016 updated by: Tabula Rasa HealthCare

Implementing an Enhanced Standardized Medication Therapy Management Approach Within a Primary Care Setting

The purpose of this study is to identify challenges and successes associated with implementing an enhanced medication therapy management service in primary care practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The specific aim of this study is to implement a Medication Therapy Management (MTM) service in primary care that is enhanced by the incorporation of pharmacogenomics (PGx) and medication risk mitigation (MRM) factor technology and is standardized by a systematic approach to evidence- and personalized-based medicine. The primary objective is to implement the systematic approach to delivering an enhanced MTM service in a primary care setting. Secondary objectives include: determine how successful the communication between prescriber and pharmacist is within implementing the service, determine how PGx testing can be incorporated into primary care prescribers' daily work flow, determine if patients are receptive to PGx testing, determine how satisfied prescribers are with an enhanced MTM clinical service and their confidence to conduct on their own, and determine if enhanced MTM optimizes or changes drug therapy for patients.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Elmwood Family Physicians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Receiving primary health care from Elmwood Family Physicians; and
  • Medicare beneficiary; and
  • Currently prescribed at least 7 medications, or prescriber feels patient would benefit from enhanced medication therapy management, or actual or suspected medication-related problem

Exclusion Criteria:

  • Not willing to participate in the study and sign informed consent; or
  • Non-English speaking or designated surrogate as translator not available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medication therapy management
Medication therapy management service that is enhanced by the incorporation of pharmacogenomics and medication risk mitigation factor technology
Other: Medication therapy management
Implementation of a systematic approach to evidence- and personalized-based medicine through a pharmacist-guided medication therapy management service
Other Names:
  • Enhanced medication therapy management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative description of process-related challenges and successes as assessed by observation and survey
Time Frame: 3 months
Implementation
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative description of bidirectional communication as assessed by turn-around times from pharmacist's recommendations delivered to prescriber's responses received
Time Frame: 3 months
Communication
3 months
Qualitative description of incorporation of pharmacogenomic testing into workflow and receptiveness as assessed by observation and survey
Time Frame: 3 months
Pharmacogenomic testing
3 months
Qualitative description of prescriber satisfaction with enhanced medication therapy management services as assessed by survey
Time Frame: 3 months
Prescriber survey
3 months
Qualitative and quantitative description of potential impact of enhanced medication therapy management services on drug regimens as assessed by before-and-after observations
Time Frame: 3 months
Impact
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tabula Rasa HealthCare

Investigators

  • Principal Investigator: Kevin T Bain, PharmD, MPH, Tabula Rasa HealthCare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MTM-309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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