Pain ManagementNCT02995278
Usage and Plan of Care Changes Due to Drug Screenings
An observational study of Pain Management, run by Data Collection Analysis Business Management.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Does not include a drug needing FDA approval and therefore it is not by definition, a Clinical Drug Trial as defined by FDA.
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2020
- Phase
- Observational
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Providers who already drug screen for their current patient population.
Who may be able to join
- 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.
Who cannot join
- Government-funded insurance data cannot be included in the study.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain Management
- Being tested
- Does not include a drug needing FDA approval and therefore it is not by definition, a Clinical Drug Trial as defined by FDA.
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Does not include a drug needing FDA approval and therefore it is not by definition, a Clinical Drug Trial as defined by FDA.Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Plan of Care Changes due to Drug Screenings
Provider based observational survey
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Data Collection Analysis Business Management
- Sponsor type
- University, hospital or other
- Collaborators
- PAS Research Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995278
- Sponsor's protocol ID
- PAS1459
- Status last verified
- Jan 2019
- First submitted
- 6 Dec 2016
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Plan of care changes by providers after toxicology testing
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Researcher Experience Assessment Documenting Usage and Plan of Care Changes Due to Drug Screenings ©
- ClinicalTrials.gov ID
- NCT02995278
- Acronym / sponsor ID
- PAS1459
- Conditions
- Pain Management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Data Collection Analysis Business ManagementUniversity, hospital or other
- Collaborators
- PAS Research Services
- Study start
- Oct 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Providers who already drug screen for their current patient population.
Key inclusion criteria (7 listed)
- Must be a Medical Practioner
- Must have a current standard operating procedure that includes obtaining/reviewing medical history.
Key exclusion criteria (1 listed)
- Government-funded insurance data cannot be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Does not include a drug needing FDA approval and therefore it is not by definition, a Clinical Drug Trial as defined by FDA. | Other | – |
Primary outcome
Plan of Care Changes due to Drug Screenings
Time frame: 3 years
Provider based observational survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: Undecided. Plan of care changes by providers after toxicology testing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management, run by Data Collection Analysis Business Management.
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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
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?
Plan of Care Changes due to Drug Screenings (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2019.