- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02210936
SCOSI-M: Preventing Prescription Drug Problems
Preventing Prescription Drug Problems: A Pilot Military Opioid Safety Initiative
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Waltham, Massachusetts, United States, 02454
- Brandeis University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a physician within one of the 3 practice environments;
- typically prescribes Schedule II opioids to 10 or more non-cancer pain patients each month;
- if community office-based, a substantial number of patients must have TRICARE (e.g., 20%); and d) willing to provide written consent for data collection and release of own SCRIPTS data.
Exclusion Criteria:
- non-physician providers who report data to the SCRIPTS (dentist, veterinarians, nurses),
- surgeons, pediatricians, or physicians predominately treating pain in cancer or surgical patients, and,
- not eligible to register as authorized SCRIPTS user.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: PDMP Data
|
The design is primarily a pre-post, non-equivalent comparison group test of program effectiveness. If final sample size permits, we will examine program effects for each practice environment separately. For measures that require interview data there will be no comparison group data. We will construct matched comparison groups of physicians for each environment for which only secondary data analysis will be conducted. The matched comparison group will be constructed using prescription data from the DoD's pharmacy data transaction system (MACH and DORN VAMC) and from SCRIPTS (community-based physicians and VA prescribers). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of SCRIPTS
Time Frame: Up to 12 months
|
Primary outcomes, or effectiveness, will be measured first by the use of SCRIPTS when prescribing opioids (e.g., % of new patients the physician queried; % of patients with long-term use the physician queried).
|
Up to 12 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 14047
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.
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