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

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.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Genetic: Pain Medication DNA Insight (TM) test

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Fort Bragg, North Carolina, United States, 28310
      • Womack Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Immediate; Subjects will receive the results of the Pain Medication DNA Insight (TM) test at Visit 1.	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.
Other: Delayed; Subjects will receive the results of the Pain Medication DNA Insight (TM) test at Visit 4. After 3 months of standard treatment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider Satisfaction, Certainty and Confidence survey	Examine trends in provider decisions in prescribing analgesics and modifying analgesic treatment plans and provider outcomes for satisfaction, certainty and confidence in dosing of analgesics with and without access to Pain Medication and Mental Health DNA Insight ™ genetic testing results. A certainty, confidence, satisfaction survey, provider perception of care and provider global impression of change surveys will be administered to the provider after each visit from each study subject.	6 months
Provider perception of care survey	Examine trends in provider decisions in prescribing analgesics and modifying analgesic treatment plans and provider outcomes in perception of care	6 months
Provider global impression of change survey	Examine trends in provider decisions in prescribing analgesics and modifying analgesic treatment plans and provider outcomes for global impression of change	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient certainty, confidence and satisfaction survey	Examine trends in patients' satisfaction, certainty and confidence in dosing of analgesics between patient groups whose providers had access to Pain Medication and Mental Health DNA Insight ™ genetic testing results and those whose providers did not have access to the genetic information.	6 months
Patient perception of care survey	Examine trends in patient perception of care in dosing of analgesics between patient groups whose providers had access to Pain Medication and Mental Health DNA Insight ™ genetic testing results and those whose providers did not have access to the genetic information.	6 months
Patient global impression of change survey	Examine trends in patients' global impression of change in dosing of analgesics between patient groups whose providers had access to Pain Medication and Mental Health DNA Insight ™ genetic testing results and those whose providers did not have access to the genetic information.	6 months
Patient Outcomes pain as assessed by the DVPRS	Compare patient-reported pain between patient groups whose providers had early access to Pain Medication and Mental Health DNA Insight ™ genetic testing results to those who had delayed access in the control period and subsequently following later access to the results. Subjects will be ask to complete the DVPRS pain scale, a visual analog scale.	6 months
Patient Outcomes pain as assessed by BPI perception of pain relief item	Compare patient-reported pain between patient groups whose providers had early access to Pain Medication and Mental Health DNA Insight ™ genetic testing results to those who had delayed access in the control period and subsequently following later access to the results. Subjects will be ask to complete the BPI perception of pain relief item prior to each provider visit.	6 months
Patient Outcomes pain as assessed by the PROMIS Pain short form	Compare patient-reported pain between patient groups whose providers had early access to Pain Medication and Mental Health DNA Insight ™ genetic testing results to those who had delayed access in the control period and subsequently following later access to the results. Subjects will be ask to complete the PROMIS pain interference short forms prior to each provider visit.	6 months
Patient Outcomes of demographics	Compare patient-reported demographics for equality in sampling	6 months
Patient Outcomes of depression as assessed by the PROMIS depression short form	Compare patient-reported depression between patient groups whose providers had early access to Pain Medication and Mental Health DNA Insight ™ genetic testing results to those who had delayed access in the control period and subsequently following later access to the results. Subjects will be ask to complete the PROMIS depression short form prior to each provider visit.	6 months
Patient Outcomes of anxiety as assessed by the PROMIS anxiety short form	Compare patient-reported anxiety between patient groups whose providers had early access to Pain Medication and Mental Health DNA Insight ™ genetic testing results to those who had delayed access in the control period and subsequently following later access to the results. Subjects will be ask to complete the PROMIS anxiety short form prior to each provider visit.	6 months

Collaborators and Investigators

• Sponsor: Defense and Veterans Center for Integrative Pain Management
• Collaborators: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Investigators: Principal Investigator: Michael Bartoszek, MD, United States Department of Defense

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: September 24, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimated): October 6, 2015

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Military
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: 409729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No