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

NCT02568618 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: 409729
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Military; Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Patient certainty, confidence and satisfaction survey

  6 months

• Patient perception of care survey

  6 months

• Patient global impression of change survey

  6 months

• Patient Outcomes pain as assessed by the DVPRS

  6 months

• Patient Outcomes pain as assessed by BPI perception of pain relief item

  6 months

Study Arms (2)

Immediate

OTHER

Subjects will receive the results of the Pain Medication DNA Insight (TM) test at Visit 1.

Genetic: Pain Medication DNA Insight (TM) test

Delayed

OTHER

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

Interventions

Pain Medication DNA Insight (TM) test GENETIC

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; Immediate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (1)

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Bartoszek, MD

  United States Department of Defense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: October 6, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 15, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)