Clinical trial NCT02568618: Patient and Provider Confidence and Satisfaction With the Clinical Use of CYP Genetic Variability
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Military
Pain
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
Collaborators: name: Henry M. Jackson Foundation for the Advancement of Military Medicine
First posted: 2015-10-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility 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

Primary outcomes:
measure: Provider Satisfaction, Certainty and Confidence survey
timeFrame: 6 months
measure: Provider perception of care survey
timeFrame: 6 months
measure: Provider global impression of change survey
timeFrame: 6 months
Secondary outcomes:
measure: Patient certainty, confidence and satisfaction survey
timeFrame: 6 months
measure: Patient perception of care survey
timeFrame: 6 months
measure: Patient global impression of change survey
timeFrame: 6 months
measure: Patient Outcomes pain as assessed by the DVPRS
timeFrame: 6 months
measure: Patient Outcomes pain as assessed by BPI perception of pain relief item
timeFrame: 6 months
measure: Patient Outcomes pain as assessed by the PROMIS Pain short form
timeFrame: 6 months
measure: Patient Outcomes of demographics
timeFrame: 6 months
measure: Patient Outcomes of depression as assessed by the PROMIS depression short form
timeFrame: 6 months
measure: Patient Outcomes of anxiety as assessed by the PROMIS anxiety short form
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
Study officials:
affiliation: United States Department of Defense
name: Michael Bartoszek, MD
role: PRINCIPAL_INVESTIGATOR
References: