Patient and Provider Confidence and Satisfaction With the Clinical Use of CYP Genetic Variability
| Status: | Terminated |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/11/2017 |
| Start Date: | July 2015 |
| End Date: | December 2017 |
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.
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.
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.
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.
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.
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
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