SPECIFIC AIMS

The United States faces significant morbidity and mortality as a result of prescription drug abuse. Over
15 million individuals age 12 and older abused prescription drugs in the past year (SAMHSA, 2015).
Prescription medications are the second highest used form of illicit substances. Among those 12 and older,
approximately 4.5 million reported abuse of pain relievers, 1.8 million reported abuse of tranquilizers, and
970,000 reported abuse of stimulants. Opiates are among the most addictive prescription medications and
their use can have severe short-term and long-term consequences. Between the years of 1999 to 2010,
overdose of prescription pain medications have more than quadrupled. As of 2012, the number of prescription
pain reliever overdose deaths exceeded the number of deaths from cocaine and heroin overdoses (NIH, 2012).
Aside from overdose risk, effects of prolonged opiate use harm the respiratory, gastrointestinal, immune,
central nervous system, along with other systems in the body (Baldini, Von Korff, & Lin, 2012). Being
prescription medications (opiates), their prescribers are often at the root of drug diversion (Rigg, Kurtz, &
Surratt, 2012); this differentiates prescription medications from other drugs, as prescription medications have a
legitimate source. Given the prevalence of prescription opiate abuse, and the prescribers role in their
diversion, it is imperative that prescribers become aware of best practice and use best judgment when
prescribing these commonly abused and highly addictive medications.
Prescriber behavior and its causes are emerging areas of research. Past research has shown that
attitudes and education can impact prescriber behavior (Lin, Alfandre, & Moore, 2007; Stanek, Renslow,&
Kalliainen, 2015). It has also been shown that medical specialty can moderate the relationship between
knowledge and prescriber behavior (Lin, Alfandre, & Moore (2007). It is not known, however, the full extent to
which medical specialty moderates the impact of knowledge on prescribing behavior. Lin, Alfandre, and Moore
(2007) limited their study to include internist and geriatrician foci. It is suspected that the inclusion of more
specialties would illuminate more differences between specialties in this regard. Patient demographics can also
influence prescriber behavior. Pletcher et al. (2008) provide an example of racial disparities in drug
prescription, suggesting minority patients are prescribed opioid pain relievers at a rate less frequent than nonminority patients. The question of differential prescription practices across demographic groups will be
explored further in the current study.
Given the public health relevance of prescription drug abuse, our goal is to gain a better understanding
of physician prescribing practices with an experimental study testing the impact of an educational intervention
on opioid prescription related attitudes and knowledge. We anticipate this intervention will alter prescriber
knowledge and attitudes toward prescription drug abuse thus improving the appropriateness with which
providers prescribe highly addictive or commonly abused substances. To establish a relationship between
attitudes, knowledge, and behavior, we will use pre and post-intervention survey data and medical chart
reviews. Pre and post-test survey data will determine if the intervention had an influence on prescriber attitudes
and knowledge. The medical chart review will match prescriber behavior against best practice standards at pre
and post-test to determine if a change in attitudes and knowledge predicts prescriber behavior. Medical chart
reviews will also provide patient demographics, which will help examine differential practices across those
factors. Including a sample of prescribers across diverse geographic and specialty areas will increase our
ability to make comparisons between specialties, and make our findings more generalizable to the general
prescribing population.
Specific Aim #1: To examine the effect knowledge and attitudes have on prescriber practices. We expect that
as knowledge increases, and attitudes about prescription drug abuse improve, that opioid prescription behavior
will become more appropriate.
Specific Aim #2: To examine if medical specialty moderates the relationship between knowledge and
attitudes, and prescribing behavior. We expect that there will be significant differences among the specialties.
Specific Aim #3: To determine if differential prescribing practices exist across patient demographic factors,
and if the intervention influences differential prescribing. We expect to find prescriptive practices differ among
patient factors such as gender, socioeconomic status, geographic location, and education.
The CDC estimates 72 billion dollars are spent, annually, on costs directly related to opioid abuse alone
just one type of prescription medication that can result in addiction and harm if abused (CDC, 2013). It is in
the best interest of public and private entities to address prescription drug abuse. Understanding prescriber
behavior will help curb prescription drug abuse by identifying causes and precursors to misprescription.

METHODS
3. RESEARCH STRATEGY
3c. Approach
To test the efficacy of provider education on opioid related knowledge, and prescriptive behaviors, a
randomized control trial will be utilized. In this trial, data will be gathered at two points and compared. A pretest assessment will provide baseline data of opioid prescribing practice and knowledge. Providers will then
receive an educational intervention, which will increase knowledge of opioid abuse, state and federal
regulations, and safe opioid alternatives. Providers will be evaluated again after the intervention to determine if
the educational intervention had an effect. Patient demographics will be studied to determine if they influence
prescribing behavior.
3c.2. Participants
3c.2.1. Recruitment
Stratified random sampling will be used to identify and recruit 150 physicians from urban and rural
settings of practice in central North Carolina. The study will accept providers from different medical
backgrounds, specialties and settings. Physicians will be identified using the North Carolina Medical Board
websites practitioner lookup. Recruitment pamphlets providing a brief overview of the study will be mailed to
600 physicians in the target area. Enrolled providers will be entered into a raffle, where ten will win prizes.
Also, both the intervention group and control group education sessions will count for continuing education
credits providing additional incentive to participate.
3c.2.2. Inclusion Criteria
To ensure all participating physicians have minimum requisite skills and education to practice legally in
their respective areas, only fully licensed medical doctors will be included in the study.
3c.2.3. Exclusion Criteria
No physicians with medical board or other health care institution suspensions or revocations will be
included in the study. Physicians with misdemeanor, DUI, DWI, or felony convictions will be excluded as well.
3c.3. Procedures
3c.3.1. Selection of participants
Due to cost restraints, 150 providers will be selected to participate. Providers will be randomly assigned
to intervention and control conditions until the limit of 150 has been met. Seventy-five providers will be
assigned to the intervention and 75 will be assigned to the control. This randomization will be performed using
a random number generator that will assign each provider a number between 1 and 2000. The random
numbers will be sorted numerically high to low, and the lower half of the participant list will receive the
intervention.
3c.3.2. Testing
A 32-item questionnaire will assess provider knowledge, beliefs, and attitudes toward opioid
prescription before and after the intervention. The attention control group will receive the questionnaire at the
same times as the control group. Six months following the educational intervention, a team of physicians will
assess opioid prescribing practices against a standard, such as the North Carolina Medical Board Policy for
The Use of Controlled Substances for the Treatment of Pain (2014). The providers individual opioid
prescribing behaviors, as determined in the medical chart reviews, will be compared against a best practices
guideline and scored.
3c.3.3. Intervention
The 75 providers receiving the intervention will attend a 4-hour class session lead by a team of trained
physicians on the research team. The 75 providers in the attention control condition will receive an educational
activity lasting 4-hours that will not include any content related to prescribing practices. The intervention activity
will focus on four areas of opioid prescription: safe opioid prescribing (clinical practice guidelines) (Cochella
and Bateman, 2011), state and federal regulations around opioid prescribing, drug diversion education, and
addiction terminology.
3c.4. Measures
3c.4.1. Questionnaire
The 32-item questionnaire will be broken into 4 sections containing 8 questions each. The four sections
will correspond to the four areas of opioid prescription focused on in the intervention as explained earlier.
Responses to questions will be measured with an 11 point Likert scale.

3c.4.2. Covariates
Covariates that may explain variability in questionnaire scores and medical chart reviews are: age,
experience, ethnicity, educational background, and practice location. These covariates will be included in the
analysis.
4. Schedule
4a. Timeline
Below, in Figure 1. is a Gantt chart showing the timeline with which the intervention activities will be
occurring. The time line will be broken into three-month periods lasting over one year. The first three months
will consist of assembling the research team, developing surveys and curriculum, and identifying eligible
participants. During the second three-month period, eligible participants will be mailed information packets, and
after the quota has been reached, participants will be assigned to their treatment condition. Instructor training
will also be done during this time period. The third time period will include the pretesting of participants, the
intervention period, and the posttest activities. Data activities such as recording, coding, and entry will begin at
this time point and continue through to the end. In the months following the intervention, medical chart reviews
and more data coding and entry will take place. The final time period is reserved for data analysis.

Figure 1. Gantt chart of activities

5. Data Management
All paperwork, including pre and post test surveys, with personal or potentially identifying information
will be securely stored in folders in a locked file cabinet. Electronic data will be deidentified as much as
possible; a measure to support this end is through the use of random participant identification numbers.
Research staff will be supplied laptops with statistical software which staff are required to use exclusively for
data entry. Data entry specific to this study is only allowed to take place on the provided laptops or on a
computer in the research office. All computers will be password protected and in the event a computer is stolen
study information can be retrieved and/or eliminated remotely.

References

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