Medication Therapy ManagementEMTMNCT02748148
Implementation Study of Enhanced Medication Therapy Management in Primary Care Practice
A study testing Medication therapy management in people with Medication Therapy Management and Pharmacogenomics, run by Tabula Rasa HealthCare at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Therapy Management, Pharmacogenomics
- What is being tested?
- Medication therapy management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not willing to participate in the study and sign informed consent; or
- Non-English speaking or designated surrogate as translator not available
Trial locations and contacts
1 site in 1 country.
United States1 site
Elmwood Family Physicians
Marlton, New Jersey, 08053
About this study
Official title: Implementing an Enhanced Standardized Medication Therapy Management Approach Within a Primary Care Setting
The purpose of this study is to identify challenges and successes associated with implementing an enhanced medication therapy management service in primary care practice.
Read the 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.
- Conditions
- Medication Therapy Management, Pharmacogenomics
- Being tested
- Medication therapy management
- Keywords
- Medication Therapy Management, Pharmacogenomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication therapy managementOther
Also called Enhanced medication therapy management
Implementation of a systematic approach to evidence- and personalized-based medicine through a pharmacist-guided medication therapy management service
| Study group | Role | What they receive |
|---|---|---|
| Medication therapy management | Experimental | Medication therapy management service that is enhanced by the incorporation of pharmacogenomics and medication risk mitigation factor technology Receives: Other: Medication therapy management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative description of process-related challenges and successes as assessed by observation and survey
Implementation
Measured: 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
Communication
Measured: 3 months
Qualitative description of incorporation of pharmacogenomic testing into workflow and receptiveness as assessed by observation and survey
Pharmacogenomic testing
Measured: 3 months
Qualitative description of prescriber satisfaction with enhanced medication therapy management services as assessed by survey
Prescriber survey
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Medication Therapy ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabula Rasa HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin T Bain, PharmD, MPH, Principal investigator, Tabula Rasa HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748148
- Sponsor's protocol ID
- MTM-309
- Acronym
- EMTM
- Status last verified
- Oct 2016
- First submitted
- 1 Apr 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18056659Kongkaew 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.
PubMed 18594048Classen 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.
PubMed 9002492Ernst 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.
PubMed 11297331Evans 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.
PubMed 10521338Doan 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.
PubMed 23482734Schwartz 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.
PubMed 29180545
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing an Enhanced Standardized Medication Therapy Management Approach Within a Primary Care Setting
- ClinicalTrials.gov ID
- NCT02748148
- Acronym / sponsor ID
- EMTM / MTM-309
- Conditions
- Medication Therapy Management, Pharmacogenomics
- Keywords
- Medication Therapy Management, Pharmacogenomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tabula Rasa HealthCareIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medication therapy management | Experimental | Other: Medication therapy managementMedication therapy management service that is enhanced by the incorporation of pharmacogenomics and medication risk mitigation factor technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Not willing to participate in the study and sign informed consent; or
- Non-English speaking or designated surrogate as translator not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication therapy managementAlso: Enhanced medication therapy managementImplementation of a systematic approach to evidence- and personalized-based medicine through a pharmacist-guided medication therapy management service | Other | Medication therapy management |
Primary outcome
Qualitative description of process-related challenges and successes as assessed by observation and survey
Time frame: 3 months
Implementation
4 secondary outcomes
Quantitative description of bidirectional communication as assessed by turn-around times from pharmacist's recommendations delivered to prescriber's responses received
Time frame: 3 months
Qualitative description of incorporation of pharmacogenomic testing into workflow and receptiveness as assessed by observation and survey
Time frame: 3 months
Qualitative description of prescriber satisfaction with enhanced medication therapy management services as assessed by survey
Time frame: 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
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Background: PubMed 18056659Budnitz 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.
- Background: PubMed 18594048Kongkaew 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.
- Background: PubMed 9002492Classen 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.
- Background: PubMed 11297331Ernst 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.
- Background: PubMed 10521338Evans 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.
- Background: PubMed 23482734Doan 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.
- Derived from this study: PubMed 29180545Schwartz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin T Bain, PharmD, MPH principal investigator
Tabula Rasa HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication therapy management in people with Medication Therapy Management and Pharmacogenomics, run by Tabula Rasa HealthCare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative description of process-related challenges and successes as assessed by observation and survey (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02748148, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.