Opioid Pain Study

Investigators
- Esmond D. Nwokeji, Doctoral Candidate, The University of Texas at Austin, College of Pharmacy;
- Andrew Eisenberg, M.D., M.H.A., Iron Mountain Medical Center and TAFP-SPARRC member;
- Carolyn Brown, Ph.D., Associate Professor, The University of Texas at Austin, College of Pharmacy; and
- Karen Rascati, Ph.D., Professor, The University of Texas at Austin, College of Pharmacy.

Background and Significance
The adequate treatment of chronic pain among patients continues to be a major public health concern. It is estimated that close to one-third of the industrialized world population suffers from some type of chronic pain. Of these sufferers, approximately 50 percent have experienced some level of disability resulting from their pain. 1 A 1999 National Pain Survey estimates that at least 50 million people in the U.S. live with chronic pain. 2

Chronic non-malignant pain (CNMP) is seen as a significant problem throughout the industrialized world, with a prevalence of 10 to 55 percent. 3 CNMP is a complex condition with intrinsic, emotional and behavioral components contributing to its etiology and severity. In 2000, the American Pain Society estimated approximately nine percent of the U.S. population suffers from moderate to severe CNMP. 4 Numerous pharmacologic and nonpharmacologic approaches are available to treat patients with CNMP. The goals of both treatment approaches are to prevent, reduce or eliminate pain, improve patient’s quality of life, restore functional capacity, and reestablish independence.

Advancements in pharmacotherapeutics have produced a number of medications created to assist physicians in managing their patients’ chronic pain. Opiate analgesics (schedule II – IV), which until 30 to 40 years ago were primarily confined to hospital and in-patient settings, are becoming widely used to treat various levels of chronic pain in the outpatient setting. 5 The use of schedule II controlled-release opioids (CR opioids) is generally accepted among prescribers as an effective palliative care method to treat pain in cancer and terminally-ill patients. These types of opioids are also seen to be effective in treating patients with moderate to severe CNMP. 5, 6 However, the use of CR opioids to treat CNMP symptoms has not been widely accepted among practitioners. 2, 7, 8

A number of critical issues currently underlie physicians’ concerns regarding the use of CR opioids to treat patients with CNMP. These problems include fear of patient addiction, physical dependence, a development of tolerance, drug diversion, illicit usage and regulatory scrutiny. Consequently, these issues have influenced physicians’ willingness to use CR opioids to treat patients suffering from moderate to severe CNMP and possible under-treatment of their CNMP patients. 2, 6-9

Little is known about family physician attitudes and beliefs toward the use of CR opioids for patients suffering from moderate to severe CNMP. Previous studies have attempted to examine the knowledge, attitudes and beliefs of physicians to better understand the reasoning underlying their treatment behaviors. 10-16 However, no formal research studies have been conducted that assess FPs attitudes or beliefs in this area using a grounded theoretical model.

Methodology
The research study will use a cross-sectional non-experimental survey design to survey TAFP members. An anonymous web-survey will be e-mailed to active family physicians listed on the TAFP membership database. Eligible participants will be active TAFP members of various backgrounds and experience levels.

The study will use the Theory of Planned Behavior (TPB) model to explore and examine factors affecting FPs attitudes and beliefs toward the use of CR opioids to treat patients with moderate to severe CNMP. Further, the study will explore the predictive utility of the Theory of Planned Behavior (TPB) in understanding FPs willingness to prescribe CR opioids to treat patients with moderate to severe CNMP.

The study will involve conducting two focus groups to obtain salient beliefs, salient referents, and control beliefs representative of the population group. 17 An e-mail invitation will be sent to TAFP committee members to participate in focus groups conducted during two TAFP conferences. Focus group size will range from 6 to 10 FP participants. The web-survey instrument will be pilot-tested among a small random sample of FPs to identify issues that may affect survey length, face validity, content, clarity, format, and organization.

The final survey instrument will be sent to FPs. Eligible physicians will be sent an invitation cover letter e-mail that will direct them to a link to the anonymous online electronic questionnaire. The electronic questionnaire will not request any personally identifiable information from the respondent. The TAFP computer server will be used to capture respondents’ data. Participants initially contacted will have the option of opting out of the survey and future e-mails.

Risks and Benefits
The privacy and confidentiality of the TAFP participants will be maintained. Researchers in the university will not have access to information that can be linked to study participants. Audio cassettes used in transcribing feedback from focus group will be coded so that no personally identifiable information is visible on them. Cassettes will be stored in a locked file cabinet and will be used only by research personnel. The audio tapes will be destroyed upon completion of the study. The data collected during the survey process will be strictly confidential. No personally identifiable information will be collected from FPs. Only the primary investigator and TAFP personnel will have access to focus group audio recordings and the database collecting electronic web-survey responses. Secured database storage will further ensure FP confidentiality.

Using the TPB, this study may help to identify and better understand specific attitudinal, belief and behavioral control factors that can influence physicians’ decision-making in the delivery of palliative care through the use of CR opioids. TAFP members may receive a direct benefit from the study through the identification of FP continuing education needs in pain management. Patients may receive indirect benefits through improved awareness of pain management practices by FPs.