NCT02568618

Patient and Provider Confidence and Satisfaction With the Clinical Use of CYP Genetic Variability

Patient and Provider Confidence and Satisfaction With the Clinical Use of CYP Genetic Variability Analysis to Guide Analgesic Treatment: A Randomized, Controlled Pilot Study Using the Pain Medication and Mental Health DNA InsightTM Test.

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Defense and Veterans Center for Integrative Pain Management · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Pain

Interventions

Type	Name	Description
GENETIC	Pain Medication DNA Insight (TM) test	The DNA insight test uses saliva to test the metabolism of certain pain and mental health medications to determine if the subject is a poor metabolizer, intermediate metabolizer or ultrarapid metabolizer.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2015-10-06
• Last updated: 2023-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study