The use of opioid medications to treat chronic pain has rapidly increased. However, opioids are associated with significant adverse events, including medical side effects, misuse, abuse, and diversion. Unfortunately, there are currently no evidence-based treatments available to reduce prescription opioid misuse or other adverse events in the primary care setting. This research will compare outcomes from two different strategies to improve the safety of opioid medications.
We propose a randomized controlled trial of a multifaceted intervention designed to improve the safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid safety, (b) assess whether participation in ISOP impacts the clinician-patient relationship, and (c) explore to what extent ISOP is associated with changes in pain intensity, function, quality of life, or depressive symptoms.
We will randomize primary care providers (PCPs) at the VA Portland Health Care System to either ISOP or the control condition; patients will be nested by clinician status. All PCPs will participate in either a two-hour educational workshop or the two-hour educational workshop + nurse care manager (NCM). The NCM will maintain a registry of enrolled patients, track urine drug test (UDT) administrations and results, and notify PCPs and provide decision support when patients have UDTs with aberrant results. The decision support will address best practices for modifying treatment for patients who misuse prescription opioids. The NCM will also meet individually with enrolled participants to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse. We will recruit 300 patients who are already prescribed chronic opioid therapy for chronic non-cancer pain. Participants will be enrolled for one year. Outcomes will be measured at baseline, and 6 and 12 months after enrollment.
Data collection is still underway and therefore, analyses have not yet begun. We hypothesize that patients randomized to the intervention will have lower rates of prescription opioid abuse, fewer adverse events, and improved relationships with their primary care provider
The objectives of this study are to evaluate the safety and acceptability of a multifaceted intervention to enhance opioid safety in patients with chronic pain. If the results from this study are significant, this will provide a pragmatic intervention to assist primary care providers in reducing prescription opioid misuse and other adverse effects, and improving patient's satisfaction in care.
- Morasco BJ, Krebs EE, Adams MH, Hyde S, Zamudio J, Dobscha SK. Clinician Response to Aberrant Urine Drug Test Results of Patients Prescribed Opioid Therapy for Chronic Pain. The Clinical Journal of Pain. 2019 Jan 1; 35(1):1-6.
- Morasco BJ, Shull SE, Adams MH, Dobscha SK, Lovejoy TI. Development of an Algorithm to Identify Cannabis Urine Drug Test Results within a Multi-Site Electronic Health Record System. Journal of medical systems. 2018 Jul 24; 42(9):163.
- Lozier CC, Nugent SM, Smith NX, Yarborough BJ, Dobscha SK, Deyo RA, Morasco BJ. Correlates of Use and Perceived Effectiveness of Non-pharmacologic Strategies for Chronic Pain Among Patients Prescribed Long-term Opioid Therapy. Journal of general internal medicine. 2018 May 1; 33(Suppl 1):46-53.
- Adams MH, Dobscha SK, Smith NX, Yarborough BJ, Deyo RA, Morasco BJ. Prevalence and Correlates of Low Pain Interference Among Patients With High Pain Intensity Who Are Prescribed Long-Term Opioid Therapy. The journal of pain : official journal of the American Pain Society. 2018 Sep 1; 19(9):1074-1081.
- Morasco BJ, Lovejoy TI, Dobscha SK, Hyde S, Shull S. Limitations of pain numeric rating scale scores collected during usual care: Need for enhanced assessment. Journal of pain research. 2018 Mar 1; 19(3):S57-S58.
Substance Abuse and Addiction, Other Conditions
Treatment - Efficacy/Effectiveness Clinical Trial
Best Practices, Comparative Effectiveness, Pharmacology