Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics
September 28, 2016 updated by: ER/LA Opioid REMS Program Companies (RPC)
Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could have greater impact on prescribing (e.g., dentists).
Trends and changes in monthly prescription volume and average monthly prescription volume will be evaluated by prescriber specialty.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
360000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 100 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects filling a prescription for a product of interest as gathered from the IMS National prescription Audit™ and IMS Health, LifeLink™
Description
Inclusion Criteria:
- Changes in number of prescriptions for prescriber types with less or more compelling reasons to prescriber ER/LA opioid analgesics
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pediatrics
|
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Surgery
|
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Pain
|
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PCP
|
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Dentist
|
|
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Emergency Medicine
|
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Oncology
|
|
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Hospice and Palliative Medicine
|
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Anesthesiology
|
|
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Neurology
|
|
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Nurse Practitioners
|
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Physical Medicine & Rehabilitation
|
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Physician Assistant
|
|
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Rheumatology
|
|
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All Other Specialties
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Monthly volume of prescriptions by specialty
Time Frame: July 2010-December 2014
|
July 2010-December 2014
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Anticipated)
July 1, 2019
Study Registration Dates
First Submitted
September 28, 2016
First Submitted That Met QC Criteria
September 28, 2016
First Posted (Estimate)
September 30, 2016
Study Record Updates
Last Update Posted (Estimate)
September 30, 2016
Last Update Submitted That Met QC Criteria
September 28, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Assessment 8
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.