Implementation Study of Enhanced Medication Therapy Management in Primary Care Practice

NCT02748148 | Completed

• 1 other identifier: MTM-309
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Therapy Management; Pharmacogenomics

Keywords

Medication Therapy Management; Pharmacogenomics

Outcome Measures

Primary Outcomes (1)

• Qualitative description of process-related challenges and successes as assessed by observation and survey

  Implementation

  3 months

Secondary Outcomes (4)

• Quantitative description of bidirectional communication as assessed by turn-around times from pharmacist's recommendations delivered to prescriber's responses received

  3 months

• Qualitative description of incorporation of pharmacogenomic testing into workflow and receptiveness as assessed by observation and survey

  3 months

• Qualitative description of prescriber satisfaction with enhanced medication therapy management services as assessed by 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

  3 months

Study Arms (1)

Medication therapy management

EXPERIMENTAL

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

Other: Medication therapy management

Interventions

Medication therapy management OTHER

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

Also known as: Enhanced medication therapy management

Medication therapy management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not willing to participate in the study and sign informed consent; or
• Non-English speaking or designated surrogate as translator not available

Sponsors & Collaborators

• Tabula Rasa HealthCare: lead

Study Sites (1)

Elmwood Family Physicians

Marlton, New Jersey, 08053, United States

Location

Related Publications (7)

• 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.

  PMID: 18056659 BACKGROUND

• 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.

  PMID: 18594048 BACKGROUND

• 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.

  PMID: 9002492 BACKGROUND

• 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.

  PMID: 11297331 BACKGROUND

• 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.

  PMID: 10521338 BACKGROUND

• 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.

  PMID: 23482734 BACKGROUND

• 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.

  PMID: 29180545 DERIVED

MeSH Terms

Interventions

Medication Therapy Management

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Study Officials

• Kevin T Bain, PharmD, MPH

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 22, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 17, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)