Clinical trial NCT02748148: Implementation Study of Enhanced Medication Therapy Management in Primary Care Practice
Official title: Implementing an Enhanced Standardized Medication Therapy Management Approach Within a Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Therapy Management
Pharmacogenomics
Keywords: Medication Therapy Management
Pharmacogenomics
Lead sponsor: Tabula Rasa HealthCare
Sponsor class: INDUSTRY
First posted: 2016-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Qualitative description of process-related challenges and successes as assessed by observation and survey
timeFrame: 3 months
Secondary outcomes:
measure: Quantitative description of bidirectional communication as assessed by turn-around times from pharmacist's recommendations delivered to prescriber's responses received
timeFrame: 3 months
measure: Qualitative description of incorporation of pharmacogenomic testing into workflow and receptiveness as assessed by observation and survey
timeFrame: 3 months
measure: Qualitative description of prescriber satisfaction with enhanced medication therapy management services as assessed by survey
timeFrame: 3 months
measure: Qualitative and quantitative description of potential impact of enhanced medication therapy management services on drug regimens as assessed by before-and-after observations
timeFrame: 3 months
Other outcomes:
Locations:
city: Marlton
country: United States
facility: Elmwood Family Physicians
state: New Jersey
Study officials:
affiliation: Tabula Rasa HealthCare
name: Kevin T Bain, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ernst FR, Grizzle AJ. Drug-related morbidity and mortality: updating the cost-of-illness model. J Am Pharm Assoc (Wash). 2001 Mar-Apr;41(2):192-9. doi: 10.1016/s1086-5802(16)31229-3.
citation: Evans WE, Relling MV. Pharmacogenomics: translating functional genomics into rational therapeutics. Science. 1999 Oct 15;286(5439):487-91. doi: 10.1126/science.286.5439.487.
citation: Doan J, Zakrzewski-Jakubiak H, Roy J, Turgeon J, Tannenbaum C. Prevalence and risk of potential cytochrome P450-mediated drug-drug interactions in older hospitalized patients with polypharmacy. Ann Pharmacother. 2013 Mar;47(3):324-32. doi: 10.1345/aph.1R621. Epub 2013 Mar 12.
citation: Schwartz EJ, Turgeon J, Patel J, Patel P, Shah H, Issa AM, Knowlton OV, Knowlton CH, Bain KT. Implementation of a Standardized Medication Therapy Management Plus Approach within Primary Care. J Am Board Fam Med. 2017 Nov-Dec;30(6):701-714. doi: 10.3122/jabfm.2017.06.170145.