Implementation Study of Enhanced Medication Therapy Management in Primary Care Practice

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

Detailed Description
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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.

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

Conditions
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Medication Therapy Management, Pharmacogenomics

Intervention / Treatment
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* Other: Medication therapy management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative description of process-related challenges and successes as assessed by observation and survey | 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 | Communication | 3 months | 
| Qualitative description of incorporation of pharmacogenomic testing into workflow and receptiveness as assessed by observation and survey | Pharmacogenomic testing | 3 months | 
| Qualitative description of prescriber satisfaction with enhanced medication therapy management services as assessed by survey | 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 | Impact | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication Therapy Management, Pharmacogenomics