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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02748148
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):
Tabula Rasa HealthCare

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

Condition or disease Intervention/treatment Phase
Medication Therapy Management Pharmacogenomics Other: Medication therapy management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementing an Enhanced Standardized Medication Therapy Management Approach Within a Primary Care Setting
Study Start Date : April 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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 Name: Enhanced medication therapy management

Primary Outcome Measures :
  1. Qualitative description of process-related challenges and successes as assessed by observation and survey [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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 ]

  2. Qualitative description of incorporation of pharmacogenomic testing into workflow and receptiveness as assessed by observation and survey [ Time Frame: 3 months ]
    Pharmacogenomic testing

  3. Qualitative description of prescriber satisfaction with enhanced medication therapy management services as assessed by survey [ Time Frame: 3 months ]
    Prescriber survey

  4. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02748148

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United States, New Jersey
Elmwood Family Physicians
Marlton, New Jersey, United States, 08053
Sponsors and Collaborators
Tabula Rasa HealthCare
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Principal Investigator: Kevin T Bain, PharmD, MPH Tabula Rasa HealthCare
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tabula Rasa HealthCare Identifier: NCT02748148    
Other Study ID Numbers: MTM-309
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tabula Rasa HealthCare:
Medication Therapy Management