Implementation Study of Enhanced Medication Therapy Management in Primary Care Practice

Medication Therapy Management Clinical Trial

— EMTM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748148
• Other study ID #: MTM-309
• Status: Completed
• Phase: N/A
• First received: April 1, 2016
• Last updated: October 14, 2016
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Tabula Rasa HealthCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Medication Therapy Management
• Pharmacogenomics

Intervention

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

Locations

Country	Name	City	State
United States	Elmwood Family Physicians	Marlton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Tabula Rasa HealthCare

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View 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. — View 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. — View Citation

Evans WE, Relling MV. Pharmacogenomics: translating functional genomics into rational therapeutics. Science. 1999 Oct 15;286(5439):487-91. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative description of process-related challenges and successes as assessed by observation and survey	Implementation	3 months	No
Secondary	Quantitative description of bidirectional communication as assessed by turn-around times from pharmacist's recommendations delivered to prescriber's responses received	Communication	3 months	No
Secondary	Qualitative description of incorporation of pharmacogenomic testing into workflow and receptiveness as assessed by observation and survey	Pharmacogenomic testing	3 months	No
Secondary	Qualitative description of prescriber satisfaction with enhanced medication therapy management services as assessed by survey	Prescriber survey	3 months	No
Secondary	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	No