Medication Therapy Management Clinical Trial
Official title:
Assessing Feasibility and Utility of Enhancing Medication Therapy Management With Pharmacist-Delivered Pharmacogenetic Testing
Verified date | October 2014 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - if patient has ever had MTM or PGx |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Duke Health Center at Southpoint | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient satisfaction with MTM and PGx | This will be assessed by a quantitative survey | 3 months after completion of MTM2 | No |
Primary | 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 | baseline and 2 months | Yes |
Primary | Number of recommended drug selection/dosing adjustments | Drug selection/doing changes will be compared between study population and chart-review controls | approximately 9 months | Yes |
Secondary | Physician time to perform MTM and PGx | end of study, approx. 9 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03258151 -
Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
|
||
Withdrawn |
NCT04893395 -
Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans
|
N/A | |
Completed |
NCT03385473 -
Individualized Antiretroviral Therapy
|
N/A | |
Completed |
NCT00757029 -
Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD)
|
Phase 4 | |
Recruiting |
NCT05063838 -
Perioperative Pharmacogenomic Testing
|
N/A | |
Completed |
NCT03276598 -
A Study on Molecular Genetics of Drug Responsiveness in Essential Hypertension
|
Phase 4 | |
Completed |
NCT03154489 -
Effectiveness of a Multidisciplinary Medication Review With Follow-up for Patients Treated With Coumarin Anticoagulants in Primary Care
|
N/A | |
Not yet recruiting |
NCT03996356 -
Clozapine Induced Weight Gain
|
||
Completed |
NCT00997789 -
Bioequivalence of Rebamipide in Korean
|
N/A | |
Recruiting |
NCT01204086 -
Pharmacogenomics Studies of Antidepressants
|
Phase 4 | |
Not yet recruiting |
NCT05247814 -
Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients
|
||
Completed |
NCT00833443 -
Study of Medical Treatment for Methamphetamine Addiction
|
Phase 2 | |
Recruiting |
NCT04449471 -
Naproxen Pharmacogenetic Study (Project 1, Aim 2)
|
Phase 4 | |
Recruiting |
NCT05805241 -
Pharmacogenetics Analysis of Fentanyl Administered in Newborns
|
||
Completed |
NCT02937545 -
Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting
|
N/A | |
Enrolling by invitation |
NCT01259973 -
Typical Versus Atypical Antipsychotics; Occupation of Striatal Receptors and the Appearance of Extrapyramidal Symptomatology, in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT03258099 -
Association of Genetic Polymorphisms With Capecitabine-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
|
||
Recruiting |
NCT05307718 -
Pharmacogenomics in Prediction of Cardiovascular Drugs Adverse Reaction
|
||
Recruiting |
NCT04964310 -
Screening of Susceptibility Genes for APAP Induced Drug Induced LIver Injury in ChiNese Population: a Case-control Study
|
||
Completed |
NCT02383290 -
The Implementation of Pharmacogenomics Into Primary Care in British Columbia
|
N/A |