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Fort Bragg, North Carolina 28310


Purpose:

This study utilizes the Medication DNA Insight™ tests for pain and mental health medications. We are testing the pain and mental health medications commonly used in pain treatment. Subjects will give a sample of saliva that will be tested for the metabolism of the different medications. Consented providers will be given the results of the test and can determine whether to change the subject's medication regimen. Providers and subjects will be ask to complete surveys both pre and post visits. The purpose is to examine provider and patient satisfaction, confidence and certainty of using the test results.


Study summary:

This is a prospective, randomized, controlled, interventional pilot study analyzing both providers' and patients' perceptions and responses to the DNA Insight test. Twelve military health system primary care providers and 4 of each provider's patients will be enrolled in the study. (12 providers and 48 patients total) Each provider's patients will be randomized into delayed treatment (Group A) or immediate treatment (Group B) at a 1:1 ratio. All patients receive the Pain Medication and Mental Health DNA InsightTM test (intervention). Results for patients in Group A will be given to the provider with a 3 month delay. Those in the 3 month delay will serve as a comparison group for the period prior to receiving intervention. Results for patients in Group B will be given to the provider without delay, 2-3 weeks after saliva sample collection. The provider will use the results of the Pain Medication and Mental Health DNA InsightTM test to evaluate whether changes of medications are indicated based on the individual patient's genetic profile. A measure of the provider's certainty, confidence, satisfaction, perception of care and global impression of change will be assessed at baseline, prior to obtaining the test results, and after obtaining the test results, as outlined in the data collection section. Patients' pain related self-reported outcomes, certainty, confidence and satisfaction will be assessed at baseline, prior to obtaining the DNA InsightTM test results, and after receipt and implementation of the test results, as described in the data collection section of the protocol. At the baseline visit (Visit 0) each enrolled patient will provide a saliva sample for the Pain Medication DNA InsightTM test that identifies genetic variation in CYP metabolism. The providers and patients will be recruited from any of the Womack Army Medical Center's Primary Care Medical Homes and family practice clinics.


Criteria:

Inclusion Criteria: - Military healthcare system beneficiary enrolled in the Womack Army Medical Center Health Care System - Age 18 or older - Patient of the enrolled provider for at least 3 months. - Persisting pain for at least 3 months, with average daily pain score of 4 or higher that is not expected to improve without directed therapy. - No history of chronic liver or kidney disease Exclusion Criteria: - Known pregnancy or breast feeding - Planned deployment, permanent change of station, or military separation within upcoming 6 months


NCT ID:

NCT02568618


Primary Contact:

Principal Investigator
Michael Bartoszek, MD
United States Department of Defense


Backup Contact:

N/A


Location Contact:

Fort Bragg, North Carolina 28310
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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