Prescription Drug ProblemsNCT02210936
SCOSI-M: Preventing Prescription Drug Problems
A study testing Educational Intervention in people with Prescription Drug Problems, run by Brandeis University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Prescription Drug Problems
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to May 2019
- Phase
- Interventional
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Prescription Drug Problems: A Pilot Military Opioid Safety Initiative
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.
- Conditions
- Prescription Drug Problems
- Being tested
- Educational Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| PDMP Data | Other | Not described Receives: Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prescription Drug ProblemsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brandeis University
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina, Medical University of South Carolina, Moncrief Army Community Hospital, William Jennings Bryan Dorn VA Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210936
- Sponsor's protocol ID
- 14047
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2014
- Last updated
- 9 Jul 2020
- Results posted
- No
Publications
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.
PubMed 29608412
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Prescription Drug Problems: A Pilot Military Opioid Safety Initiative
- ClinicalTrials.gov ID
- NCT02210936
- Acronym / sponsor ID
- 14047
- Conditions
- Prescription Drug Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Brandeis UniversityUniversity, hospital or other
- Collaborators
- University of South Carolina, Medical University of South Carolina, Moncrief Army Community Hospital, William Jennings Bryan Dorn VA Medical Center
- Study start
- Jul 2014
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 7 Aug 2014 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDMP Data | Other | Other: Educational Intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Educational InterventionThe 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). | Other | PDMP Data |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 29608412Larson 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Prescription Drug Problems, run by Brandeis University at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Use of SCRIPTS (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02210936, which also lists 1 linked publication.
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 9 Jul 2020.