PharmacogeneticsNCT01970774
Medication Therapy Management With Pharmacogenetic Testing
A study testing MTM with PGx in people with Pharmacogenetics and Medication Therapy Management, run by Duke University at 1 site in United States.
Trial summary
This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx) testing as part of a standard medication therapy management (MTM) session for patients taking multiple medications, a high-risk population for adverse drug reactions and non-response. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacogenetics, Medication Therapy Management
- What is being tested?
- MTM with PGx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- currently prescribed 3 medications, one of which must be simvastatin or clopidogrel
- 18 years of age or older
- English speaking
- patients of Mahesh Patel or William Kraus at Duke Southpoint Clinic
Who cannot join
- if patient has ever had MTM or PGx
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Health Center at Southpoint
Durham, North Carolina, 27713
About this study
Official title: Assessing Feasibility and Utility of Enhancing Medication Therapy Management With Pharmacist-Delivered Pharmacogenetic Testing
This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx) testing as part of a standard medication therapy management (MTM) session for patients taking multiple medications, a high-risk population for adverse drug reactions and non-response. Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are minimal with the primary risks being associated with loss of confidentiality, typical discomfort associated with acquiring blood samples, and genetic discrimination.
- Conditions
- Pharmacogenetics, Medication Therapy Management
- Being tested
- MTM with PGx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTM with PGxOther
Patients will attend MTM sessions and receive PGx testing
| Study group | Role | What they receive |
|---|---|---|
| MTM and PGx | Experimental | Participants attend two MTM sessions and have PGx testing Receives: Other: MTM with PGx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with MTM and PGx
This will be assessed by a quantitative survey
Measured: 3 months after completion of MTM2
Change in clinical biomarkers associated with drug therapy
Changes in biomarkers before and after MTM/PGx will be measured. Biomarkers of study group will be compared to chart-review control
Measured: baseline and 2 months
Number of recommended drug selection/dosing adjustments
Drug selection/doing changes will be compared between study population and chart-review controls
Measured: approximately 9 months
Secondary outcomes (1)
Physician time to perform MTM and PGx
Measured: end of study, approx. 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacogeneticsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Haga, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970774
- Sponsor's protocol ID
- Pro00048123
- Status last verified
- Oct 2014
- First submitted
- 23 Oct 2013
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Feasibility and Utility of Enhancing Medication Therapy Management With Pharmacist-Delivered Pharmacogenetic Testing
- ClinicalTrials.gov ID
- NCT01970774
- Acronym / sponsor ID
- Pro00048123
- Conditions
- Pharmacogenetics, Medication Therapy Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Oct 2013 (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.
This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx) testing as part of a standard medication therapy management (MTM) session for patients taking multiple medications, a high-risk population for adverse drug reactions and non-response. Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are minimal with the primary risks being associated with loss of confidentiality, typical discomfort associated with acquiring blood samples, and genetic discrimination.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MTM and PGx | Experimental | Other: MTM with PGxParticipants attend two MTM sessions and have PGx testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- currently prescribed 3 medications, one of which must be simvastatin or clopidogrel
- 18 years of age or older
- English speaking
- patients of Mahesh Patel or William Kraus at Duke Southpoint Clinic
Key exclusion criteria (1 listed)
- if patient has ever had MTM or PGx
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 |
|---|---|---|
| MTM with PGxPatients will attend MTM sessions and receive PGx testing | Other | MTM and PGx |
Primary outcome
Patient satisfaction with MTM and PGx
Time frame: 3 months after completion of MTM2
This will be assessed by a quantitative survey
Change in clinical biomarkers associated with drug therapy
Time frame: baseline and 2 months
Changes in biomarkers before and after MTM/PGx will be measured. Biomarkers of study group will be compared to chart-review control
Number of recommended drug selection/dosing adjustments
Time frame: approximately 9 months
Drug selection/doing changes will be compared between study population and chart-review controls
1 secondary outcome
Physician time to perform MTM and PGx
Time frame: end of study, approx. 9 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 20 Apr 2015.
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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.
Susanne Haga, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTM with PGx in people with Pharmacogenetics and Medication Therapy Management, run by Duke University 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 4 inclusion and 1 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 20 Apr 2015. 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?
Patient satisfaction with MTM and PGx (time frame: 3 months after completion of MTM2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2015.