NCT02210936

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

4.8 years

First QC Date

July 10, 2014

Last Update Submit

July 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Use of SCRIPTS

    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

Study Arms (1)

PDMP Data

OTHER
Other: Educational Intervention

Interventions

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).

PDMP Data

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brandeis University

Waltham, Massachusetts, 02454, United States

Location

Related Publications (1)

  • Larson MJ, Browne C, Nikitin RV, Wooten NR, Ball S, Adams RS, Barth K. Physicians report adopting safer opioid prescribing behaviors after academic detailing intervention. Subst Abus. 2018;39(2):218-224. doi: 10.1080/08897077.2018.1449175. Epub 2018 May 4.

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

August 7, 2014

Study Start

July 1, 2014

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations