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PainEarly Phase 1GenomicsNCT02568618

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

A Early Phase 1 study testing Pain Medication DNA Insight (TM) test in people with Pain, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Pain Medication DNA Insight (TM) test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
Jul 2015to Dec 2017
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Known pregnancy or breast feeding
  • Planned deployment, permanent change of station, or military separation within upcoming 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Womack Army Medical Center

    Fort Bragg, North Carolina, 28310

Other trials in United States

About this study

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.

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.

Read the 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
Being tested
Pain Medication DNA Insight (TM) test
Keywords
Military, Pain
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Medication DNA Insight (TM) testGenetic

    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.

Study groups in NCT02568618
Study groupRoleWhat they receive
ImmediateOtherSubjects will receive the results of the Pain Medication DNA Insight (TM) test at Visit 1.
Receives: Genetic: Pain Medication DNA Insight (TM) test
DelayedOtherSubjects will receive the results of the Pain Medication DNA Insight (TM) test at Visit 4. After 3 months of standard treatment.
Receives: Genetic: Pain Medication DNA Insight (TM) test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. 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

    Measured: 6 months

Secondary outcomes (9)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. 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.

    Measured: 6 months

  7. Patient Outcomes of demographics

    Compare patient-reported demographics for equality in sampling

    Measured: 6 months

  8. 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.

    Measured: 6 months

  9. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionOct 2017
  4. Study completionDec 2017

Why it stopped: Sponsor pulled funding related to enrollment pace.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02568618
Sponsor's protocol ID
409729
Acronym
Genomics
Status last verified
Apr 2023
First submitted
24 Sep 2015
Last updated
15 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Pain Medication DNA Insight (TM) test in people with Pain, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor pulled funding related to enrollment pace.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Provider Satisfaction, Certainty and Confidence survey (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02568618.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.

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