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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02995278
Other study ID # PAS1459
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 2016
Est. completion date October 2020

Study information

Verified date January 2019
Source Data Collection Analysis Business Management
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this minimal risk, observational survey is to document the accuracy, benefits, and how qualitative and quantitative results affect patients' plan of care.


Description:

Pain is the most common reason patients consult primary care providers. According to recent surveys, One in six Americans live with chronic or recurrent pain and pay an estimated $120 billion a year in medical costs in the United States. Oral opioids are the common treatment options for various chronic pains including joint pain, musculoskeletal pain, neuropathic pain and migraines. This narcotic-based management of pain is often associated with undesirable side effects with addictive and potential abuse.

To ensure proper usage of prescribed medications, physicians use drug screens to monitor therapeutic levels and test for presence of illegal drugs or medications that may cause a drug-drug interaction. Upon receiving quantitative or qualitative results from these drug screens, the physician may change the treatment plan for patients to improve efficacy of prescribed medications.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2000
Est. completion date October 2020
Est. primary completion date October 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Must be a Medical Practioner

- Medical Doctor (MD)

- Doctor of Osteopathic (DO)

- Physician Assistant (PA)

- Advanced Practice Registered Nurse (APRN)

- Nurse Practioner (NP)

- Must have a current standard operating procedure that includes obtaining/reviewing medical history.

Exclusion Criteria:

- Government-funded insurance data cannot be included in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Does not include a drug needing FDA approval and therefore it is not by definition, a Clinical Drug Trial as defined by FDA.


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Data Collection Analysis Business Management PAS Research Services

Outcome

Type Measure Description Time frame Safety issue
Primary Plan of Care Changes due to Drug Screenings Provider based observational survey 3 years
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