Usage and Plan of Care Changes Due to Drug Screenings

Clinical Researcher Experience Assessment Documenting Usage and Plan of Care Changes Due to Drug Screenings ©

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.

Study Overview

• Status: Unknown
• Conditions: Pain Management
• Intervention / Treatment: Other: Does not include a drug needing FDA approval and therefore it is not by definition, a Clinical Drug Trial as defined by FDA.

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Providers who already drug screen for their current patient population.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plan of Care Changes due to Drug Screenings	Provider based observational survey	3 years

Collaborators and Investigators

• Sponsor: Data Collection Analysis Business Management
• Collaborators: PAS Research Services

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PAS1459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Plan of care changes by providers after toxicology testing