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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568618
Recruitment Status : Terminated (Sponsor pulled funding related to enrollment pace.)
First Posted : October 6, 2015
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Pathway Genomics
Henry M. Jackson Foundation for the Advancement of Military Medicine
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management

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.

Condition or disease Intervention/treatment Phase
Pain Genetic: Pain Medication DNA Insight (TM) test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : July 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Provider Satisfaction, Certainty and Confidence survey [ Time Frame: 6 months ]
    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.

  2. Provider perception of care survey [ Time Frame: 6 months ]
    Examine trends in provider decisions in prescribing analgesics and modifying analgesic treatment plans and provider outcomes in perception of care

  3. Provider global impression of change survey [ Time Frame: 6 months ]
    Examine trends in provider decisions in prescribing analgesics and modifying analgesic treatment plans and provider outcomes for global impression of change


Secondary Outcome Measures :
  1. Patient certainty, confidence and satisfaction survey [ Time Frame: 6 months ]
    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.

  2. Patient perception of care survey [ Time Frame: 6 months ]
    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.

  3. Patient global impression of change survey [ Time Frame: 6 months ]
    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.

  4. Patient Outcomes pain as assessed by the DVPRS [ Time Frame: 6 months ]
    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.

  5. Patient Outcomes pain as assessed by BPI perception of pain relief item [ Time Frame: 6 months ]
    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. Patient Outcomes pain as assessed by the PROMIS Pain short form [ Time Frame: 6 months ]
    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.

  7. Patient Outcomes of demographics [ Time Frame: 6 months ]
    Compare patient-reported demographics for equality in sampling

  8. Patient Outcomes of depression as assessed by the PROMIS depression short form [ Time Frame: 6 months ]
    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.

  9. Patient Outcomes of anxiety as assessed by the PROMIS anxiety short form [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568618


Locations
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United States, North Carolina
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310
Sponsors and Collaborators
Defense and Veterans Center for Integrative Pain Management
Pathway Genomics
Henry M. Jackson Foundation for the Advancement of Military Medicine
Investigators
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Principal Investigator: Michael Bartoszek, MD United States Department of Defense
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Responsible Party: Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier: NCT02568618    
Other Study ID Numbers: 409729
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Defense and Veterans Center for Integrative Pain Management:
Military
Genomics
Pain
Additional relevant MeSH terms:
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Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs