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Trial record 12 of 1105 for:    pharmacogenomics OR pharmacogenetics

Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting

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ClinicalTrials.gov Identifier: NCT02937545
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study aims to compare patient use of and satisfaction with community pharmacist-delivered pharmacogenetic (PGx) testing delivered along or as part of a medication therapy management (MTM) service. Pharmacist and patient outcome measures will be collected by surveys, interviews, and review of pharmacy records.

Condition or disease Intervention/treatment Phase
Pharmacogenetics Other: Medication Therapy Management Other: Pharmacogenetic testing Not Applicable

Detailed Description:
This study aims to investigate the delivery of pharmacogenetic (PGx) testing alone or in combination with Medication Therapy Management (MTM) in the community pharmacy setting in order to assess and compare the two delivery models. Using a clust randomized trial, these effects of these two models will be compared. Pharmacist and patient outcome measures will be collected by survey, interviews, and review of pharmacy records. The investigators intend to compare the effect of PGx alone and PGx with MTM from the pharmacy perspective (to assess impact on workflow/operations) and patient perspective (to assess acceptance of testing, understanding of results, medication adherence, and overall satisfaction with delivery model). In the PGx only arm, pharmacists will offer PGx testing to patients who are prescribed one of the 10 eligible drugs (aripiprazole, carisoprodol, celecoxib, citalopram, clopidogrel, metoprolol, nortriptyline, paroxetine, simvastatin, warfarin) and will return results to the patient and physician with any recommendations for drug or dosage changes based on results. In the PGx and MTM arm, pharmacists will offer PGx testing to patients prescribed one of the 10 eligible drugs and provide two MTM sessions: one at the time of testing, and one when results are returned. All patients will be surveyed before PGx testing and 3 months after receiving results. Pharmacists will be surveyed prior to their participation and following the conclusion of the study. Pharmacists will also conduct a chart review of patients and document all interactions with enrolled patients and their providers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting
Actual Study Start Date : February 22, 2017
Actual Primary Completion Date : September 10, 2019
Actual Study Completion Date : September 10, 2019

Arm Intervention/treatment
Experimental: PGx Only
Patients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results.
Other: Pharmacogenetic testing
Community pharmacist will provide pharmacogenetic testing.
Other Name: PGx

Experimental: PGx + MTM
Patients will receive pharmacogenetic testing along with medication therapy management. Two MTM sessions will be conducted: one at the time testing is ordered and the testing sample is collected, and one when results are returned to the patient. Pharmacists will make recommendations for drug/dose changes based on medication action plan developed during MTM and the PGx results.
Other: Medication Therapy Management
Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing
Other Name: MTM + PGx

Other: Pharmacogenetic testing
Community pharmacist will provide pharmacogenetic testing.
Other Name: PGx




Primary Outcome Measures :
  1. Patient acceptance of PGx services offered in community pharmacy setting [ Time Frame: 3 months following receipt of results ]
    Patient surveys

  2. Comprehension of test results and health implications for results [ Time Frame: 3 months following receipt of results ]
    Patient survey

  3. Patient Satisfaction [ Time Frame: 3 months following receipt of results ]
    Patient survey

  4. Medication adherence [ Time Frame: 3 months following receipt of results and 6 months following receipt of results ]
    Actual refill data identified via chart review, and patient-reported adherence via survey


Secondary Outcome Measures :
  1. Change in acceptance of use of PGx [ Time Frame: Baseline and 3 months following conclusion of trial ]
    Pharmacist surveys

  2. Pharmacist variables that may affect sustainability [ Time Frame: Baseline ]
    Pharmacist survey (assessing knowledge of PGx, demographics of individual)

  3. Pharmacy variables that may affect sustainablity [ Time Frame: 3 months following end of trial ]
    Pharmacist survey, communication log (assess time to deliver services, specific pharmacy features)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pharmacist participants must be community pharmacists licensed and practicing in North Carolina
  • Patient participants must be prescribed one of the 10 eligible medications (aripiprazole, carisoprodol, celecoxib, citalopram, clopidogrel, metoprolol, nortriptyline, paroxetine, simvastatin, warfarin)
  • Patient participants must be able to consent to participating and testing on their own, and be able to read English

Exclusion Criteria:

  • Patients who have previously undergone pharmacogenetic testing will not be eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937545


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
National Institute of General Medical Sciences (NIGMS)

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02937545     History of Changes
Other Study ID Numbers: Pro00068552
2R01GM081416-08A1 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No