This trial is active, not recruiting.

Condition prescription drug problems
Treatment educational intervention
Sponsor Brandeis University
Collaborator University of South Carolina
Start date July 2014
End date August 2016
Trial size 93 participants
Trial identifier NCT02210936, 14047


Brandeis University and University of South Carolina (USC) have joined together to develop the South Carolina Opioid Safety Initiative - Military (SCOSI-M), to develop an academic detailing (medical education) intervention for physicians and evaluate its effectiveness in a pilot study. The goal of the intervention is to increase the use of safe prescribing and prescription monitoring practices among primary care physicians. The research team will design and pilot an educational intervention for physicians who treat military personnel, veterans, and their families with prescription opioids. The overall aim of SCOSI-M is to prevent the onset or progression of prescription drug problems among Iraq and Afghanistan veterans, military members, and their families who are at high risk for developing problems if their treatment involves long-term use of an opioid.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
educational intervention
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).

Primary Outcomes

time frame: Up to 12 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: 1. a physician within one of the 3 practice environments; 2. typically prescribes Schedule II opioids to 10 or more non-cancer pain patients each month; 3. 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: 1. non-physician providers who report data to the SCRIPTS (dentist, veterinarians, nurses), 2. surgeons, pediatricians, or physicians predominately treating pain in cancer or surgical patients, and, 3. not eligible to register as authorized SCRIPTS user.

Additional Information

Official title Preventing Prescription Drug Problems: A Pilot Military Opioid Safety Initiative
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Brandeis University.