Lumbosacral Muscle StrainNCT00915291
Evaluating Effectiveness of Educational Intervention to Help Physicians Address Inappropriate Patient Requests for Direct-to-Consumer Advertised Prescription Medications
A study testing Web-based educational modules in people with Lumbosacral Muscle Strain, run by American Medical Association at 4 sites in United States.
Trial summary
The purpose of this study is to determine whether physicians can be educated to better handle inappropriate requests from patients for direct-to-consumer advertised prescription medications. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lumbosacral Muscle Strain
- What is being tested?
- Web-based educational modules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2007to Oct 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resident physicians in internal medicine or family medicine specialties at participating study sites
Who cannot join
- Completed less than 10 months of residency
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas at Houston Medical School
Houston, Texas, 77030
Creighton University School of Medicine
Omaha, Nebraska, 68131
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Sound Prescribing Study - Assessing the Impact of Pharmaceutical Marketing and Promotional Practices on Physician Prescribing
The purpose of this study is to determine whether physicians can be educated to better handle inappropriate requests from patients for direct-to-consumer advertised prescription medications.
Read the detailed description
Since changes in FDA regulation direct-to-consumer advertising (DTCA), pharmaceutical companies have expended increasing resources to market their products to the public. This has led to increased awareness of diseases and potential treatments, but it has also created more public demand for medications that may not be appropriate for a patient's clinical presentation. This study aims to provide physicians with the knowledge and skills required to help them address inappropriate DTCA medication requests from patients.
- Conditions
- Lumbosacral Muscle Strain
- Being tested
- Web-based educational modules
- Keywords
- medical education, clinical decisionmaking, pharmaceutical marketing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based educational modulesOther
Interactive case-based modules that includes video vignettes of clinical interactions between hypothetical patients interacting with physicians
| Study group | Role | What they receive |
|---|---|---|
| Usual education | No intervention | Participants randomized into the "no intervention" arm were not exposed to the web-based educational modules |
| Web-based educational modules | Experimental | Participants randomized into the intervention arm were exposed to the web-based educational modules Receives: Other: Web-based educational modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision to prescribe celecoxib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startMay 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral Muscle StrainStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Medical Association
- Sponsor type
- University, hospital or other
- Collaborators
- Attorney General Consumer & Prescriber Education Grant
- Investigators
- Audiey C Kao, MD, PhD, Principal investigator, American Medical Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915291
- Sponsor's protocol ID
- AMA-ES62
- Status last verified
- Jun 2009
- First submitted
- 5 Jun 2009
- Last updated
- 8 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sound Prescribing Study - Assessing the Impact of Pharmaceutical Marketing and Promotional Practices on Physician Prescribing
- ClinicalTrials.gov ID
- NCT00915291
- Acronym / sponsor ID
- AMA-ES62
- Conditions
- Lumbosacral Muscle Strain
- Keywords
- medical education, clinical decisionmaking, pharmaceutical marketing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- American Medical AssociationUniversity, hospital or other
- Collaborators
- Attorney General Consumer & Prescriber Education Grant
- Study start
- May 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 8 Jun 2009 (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.
The purpose of this study is to determine whether physicians can be educated to better handle inappropriate requests from patients for direct-to-consumer advertised prescription medications.
Detailed description
Since changes in FDA regulation direct-to-consumer advertising (DTCA), pharmaceutical companies have expended increasing resources to market their products to the public. This has led to increased awareness of diseases and potential treatments, but it has also created more public demand for medications that may not be appropriate for a patient's clinical presentation. This study aims to provide physicians with the knowledge and skills required to help them address inappropriate DTCA medication requests from patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual education | No intervention | –Participants randomized into the "no intervention" arm were not exposed to the web-based educational modules |
| Web-based educational modules | Experimental | Other: Web-based educational modulesParticipants randomized into the intervention arm were exposed to the web-based educational modules |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Resident physicians in internal medicine or family medicine specialties at participating study sites
Key exclusion criteria (1 listed)
- Completed less than 10 months of residency
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 |
|---|---|---|
| Web-based educational modulesInteractive case-based modules that includes video vignettes of clinical interactions between hypothetical patients interacting with physicians | Other | Web-based educational modules |
Primary outcome
Decision to prescribe celecoxib
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 8 Jun 2009.
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.
Audiey C Kao, MD, PhD principal investigator
American Medical Association
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based educational modules in people with Lumbosacral Muscle Strain, run by American Medical Association at 4 sites 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 1 inclusion and 1 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 8 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Decision to prescribe celecoxib. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2009; AzTrials last refreshed its copy on 31 Oct 2026.