Implementation Study of Enhanced Medication Therapy Management in Primary Care Practice

NCT ID: NCT02748148

Last Updated: 2016-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-09-30

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.

Conditions

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Medication Therapy Management Pharmacogenomics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Medication therapy management

Medication therapy management service that is enhanced by the incorporation of pharmacogenomics and medication risk mitigation factor technology

Group Type EXPERIMENTAL

Medication therapy management

Intervention Type OTHER

Implementation of a systematic approach to evidence- and personalized-based medicine through a pharmacist-guided medication therapy management service

Interventions

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Medication therapy management

Implementation of a systematic approach to evidence- and personalized-based medicine through a pharmacist-guided medication therapy management service

Intervention Type OTHER

Other Intervention Names

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Enhanced medication therapy management

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tabula Rasa HealthCare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin T Bain, PharmD, MPH

Role: PRINCIPAL_INVESTIGATOR

Tabula Rasa HealthCare

Locations

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Elmwood Family Physicians

Marlton, New Jersey, United States

Site Status

Countries

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United States

References

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Budnitz DS, Shehab N, Kegler SR, Richards CL. Medication use leading to emergency department visits for adverse drug events in older adults. Ann Intern Med. 2007 Dec 4;147(11):755-65. doi: 10.7326/0003-4819-147-11-200712040-00006.

Reference Type BACKGROUND
PMID: 18056659 (View on PubMed)

Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother. 2008 Jul;42(7):1017-25. doi: 10.1345/aph.1L037. Epub 2008 Jul 1.

Reference Type BACKGROUND
PMID: 18594048 (View on PubMed)

Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1997 Jan 22-29;277(4):301-6.

Reference Type BACKGROUND
PMID: 9002492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11297331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10521338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23482734 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29180545 (View on PubMed)

Other Identifiers

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MTM-309

Identifier Type: -

Identifier Source: org_study_id

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