Abstract Background Morbidity and mortality from prescription opioids has reached unprecedented levels. Opioids remain part of chronic pain treatment in primary care. This study was designed to determine whether one-on-one care management increases procurement of Naloxone, an opioid antagonist shown to reduce morbidity and mortality in opioid overdoses. Methods Participants included all patients ≥18 years enrolled in a primary care-based chronic pain management program and who were prescribed a daily dose of opioids for treatment of chronic pain. In total, 153 patients chose to participate. Each had a 1 h one-on-one education meeting with a registered nurse. Results Among the enrolled, eight patients (5.2%) had procured Naloxone prior to intervention. Overall, 31 additional patients (20.2%) procured Naloxone after intervention, a 288% relative improvement in the attainment of Naloxone (P < 0.0001) (χ2 = 29.032 with 1 degree freedom). Of the 114 participants who never procured Naloxone, 69.3% believed it was unnecessary, 20% forgot about Naloxone, 8% said it was cost prohibitive, 3.5% had access concerns and 0.9% had concerns about side effects. Conclusion Direct one-on-one nurse care management sessions were associated with an increased procurement of Naloxone in a primary care-based pain management program. A significant number of patients believed Naloxone was unnecessary after the intervention. chronic disease, drug abuse, primary care Background As pain treatment options remain limited,1 and judicious use of opioids currently remain a part of recognized guidelines for chronic pain management by organizations like the Centers for Disease Control and Prevention (CDC),2 it is critical that efforts continue in preventing opioid overdose deaths.3 Opioid drug overdose has quadrupled in the United States from 1993 to 2010.4,5 Emergency room visits have increased from 7/100 000 population to 27/100 000 population during the same period of time.6–9 Morbidity from overdoses involving opioid analgesics has more than tripled from 1999 to 2013.6–9 In 2013, twice as many deaths occurred from prescription opioids, compared to heroin overdose.10 Currently, roughly one-sixth of the adult population is at particular risk for opioid misuse.11 These statistics underscore the need for change. Prescribers need to adapt in order to control this growing problem. The solution is complex and involves a comprehensive approach based on patients’ physical and psychological needs. The solution must draw on a thorough understanding of each patient’s pain, shared decision-making and selective use of both pharmacological and non-pharmacological treatments.11 Repeat visits with accumulation of data and performance over time are most likely to occur in primary care, and therefore offer a unique opportunity to improve chronic pain management. One potential interaction that has proven to save lives is giving patients access to opioid antagonists. A CDC report showed that Naloxone saved more than 10 000 lives from 1996 to 2010 and is currently considered the standard of care for opioid overdose.12 Between 2014 and 2015, the FDA fast-tracked two opioid reversal agents to be taken by people without medical training in the general public.13 Physicians are now asked to co-prescribe the opioid antagonist with chronic opioid analgesia.13 Unfortunately, Naloxone prescriptions in the United States have only increased from 2.8 to 3.2 million between 2009 and 2015.14 New methods are necessary to expand the attainment of Naloxone in at-risk populations within the primary care setting. One-on-one care management education could be an important way to fully inform patients about potential life-saving medications like Naloxone and increase penetration into the at-risk population. One-on-one care management education fits into the broader category of a brief intervention. Brief interventions have been shown to help people who are at risk for substance abuse change their behavior.15 Brief interventions are personalized, empathic, non-judgmental informative sessions.16 More specifically, brief interventions that offer motivational advice can increase the likelihood of behavioral change in substance abuse disorders.17 Interventions as short as 5 min have been proven to be effective in changing abuse behavior.18 Receiving advice in the primary care setting, where a strong rapport exists, is a natural format to express concern for the welfare of patients and change behavior. Methods This study took place in one of Intermountain Healthcare’s outpatient primary care facilities in 2017. The study was approved by the Intermountain Healthcare Institutional Review Board. Voluntary consent was obtained from all participants. The total number of patients cared for at this facility is ~20 000. This care facility had nine patient exam rooms and two consultation rooms. The functional work force included four physicians, three nurses, five medical assistants, one health advocate and six support staff who were all working full-time. The work force also included a counselor and a diabetic educator who each worked part-time. Before the intervention, patients who received pain management at this facility were seen quarterly by their physician. Usual care included an assessment of pain control, medication review, an evaluation of physical and mental health and a directed physical exam. Usual care also involved the patient returning to the clinic monthly to obtain their opioid prescription, accompanied by a Naloxone prescription. Prior to the study, patients were able to obtain Naloxone from a pharmacy without a prescription. The clinic’s usual care of co-prescribing Naloxone with the opioid prescription, without giving any unsolicited information, was believed to be sufficient to promote Naloxone procurement. Study participants included all patients (≥18 years old) enrolled in a primary care-based chronic pain management program. All patients in this study were on a daily scheduled dose of opioids for treatment of chronic pain. Each participant had a 1 h one-on-one care management meeting with a registered nurse within the preceding 12 months at the primary care facility. In addition to reviewing the participant’s pain history, and having each participant fill out a pain coping survey, a Current Opioid Misuse Measure and a STOP-BANG questionnaire, each participant received education on non-pharmacological treatments of pain, Naloxone reversal of overdose and information on local self-help groups. The education that specifically focused on Naloxone was delivered in a motivational way using the FRAMES model.19 This education was not delivered in usual care in this facility prior to this intervention. The total number of patients receiving chronic pain management, and who underwent this intervention at this facility, was 162. The initial number identified for inclusion was 162. Of the 162 identified participants who were offered a voluntary three-question survey regarding Naloxone, 153 chose to participate in the study. Our care management team answered any participant questions and collected the completed forms. This cross-sectional study compared subjects who were enrolled in a primary care-based chronic pain management program before and after a 1 h one-on-one care management meeting with a registered nurse at the primary care setting, involving both pain management education and overdose education within the preceding twelve months. The three-question survey was administered to each participant where each of the following questions was presented individually, in this order: Y/N In the last 12 months, did you have at least one dose of Naloxone at home before you went through one-on-one pain management with our Care Manager? Y/N In the last 12 months, did you obtain at least one dose of Naloxone since having your meeting with our Care Manager? If you have not obtained at least one dose of Naloxone in the last 12 months, what are the reasons for this? (you may mark more than one) □ Did not think Naloxone was necessary □ Cost □ Concern about side effects □ Other ___________________________________ Statistical methods The primary statistical analysis of this cross-sectional study was a 2 × 2 contingency table using McNemar’s test.20 Results This study was conducted from January 2017 to May 2017. One hundred sixty-two patients were identified for inclusion. Of the 162 identified participants who were offered a voluntary three-question survey regarding Naloxone, 153 (94.4%) chose to participate in the study. Of the 153 who chose to participate, 107 were female and 46 were male, with the mean age being 63.2 years. Over 99% of the participants were non-Hispanic white. Among the 153 patients, eight patients (5.2%) had procured Naloxone prior to the intervention. Overall, 31 additional patients (20.2%) procured Naloxone after the intervention (Fig. 1). This was a 288% relative improvement in the procurement of Naloxone (P < 0.0001) (χ2 = 29.032 with 1 degree freedom). This resulted in a 25.4% overall attainment of Naloxone. There was no significant difference in the demographics of the group that attained Naloxone (100% non-Hispanic White, 63.1 years old, 10/39 male) versus the group that did not attain Naloxone (99% non-Hispanic White, 63.2 years old, 36/114 male). Of the 114 patients who never obtained Naloxone, 69.3% did not think it was necessary, 20% forgot about Naloxone after receiving their education, 8% said it was cost prohibitive, 3.5% said their pharmacy did not carry Naloxone. Lastly, 0.9% chose not to obtain Naloxone due to concerns about side effects (Fig. 2). Fig. 1 View largeDownload slide Illustrates Naloxone procurement before and after one-on-one management intervention by the 153 participants. Fig. 1 View largeDownload slide Illustrates Naloxone procurement before and after one-on-one management intervention by the 153 participants. Fig. 2 View largeDownload slide Illustrates the reasons 114 participants did not procure Naloxone. Fig. 2 View largeDownload slide Illustrates the reasons 114 participants did not procure Naloxone. Discussion Main findings of this study With any opioid use for chronic pain management, it is imperative that every effort is made to improve safety. In this primary care-based study, which involved patients who chronically use opioids as part of their pain management plan, the procurement of Naloxone had a relative improvement of 288% after direct one-on-one care management education. The primary reasons patients in this study did not procure Naloxone were believing it to be unnecessary, forgetfulness and cost. What is already known on the topic In the United States, from 1995 to 2010, one strategy to decrease opioid deaths has been to implement community-based education and distribution of Naloxone. In total, 188 community distribution centers have distributed 53 032 doses and reported 10 171 opioid overdose reversals. The majority of these centers (129) were state- sponsored.21 Opioid death rates have been reduced in the state sponsored community centers. These community centers have been mostly located in areas where high-risk street drug abuse is present.22 This strategy does not necessarily catch most people who are undergoing prescription opioid pain management. Primary care physicians are one of the main groups to deliver chronic pain management. Chronic pain management is time-intensive, emotionally intensive and requires comprehensive knowledge. This type of care also demands an understanding of the pathophysiology of all types of pain, and a working knowledge of all non-pharmacological treatments.11 Judicious use of all pharmacological (non-opioid and opioid) interventions is imperative. Limitations of this study This research was done in the format of a cross-sectional, retrospective study. This type of study has inherent limitations. Recall bias of the participants could skew the data. Attribution bias is also possible, as many different inputs regarding opioid abuse and Naloxone’s reversal of overdoses (e.g. advertising on billboards along highways) were occurring in the United States during this study’s time frame. A large prospective study could further validate this research. This study was also completed at one primary care site, where each physician had familiarity with fellow doctors. Other practices might conform to a different practice style that could increase or decrease the initial percentage of patients who attain Naloxone. Limitations specific to this study are mostly related to the intervention. The intervention was a 1 h meeting with a Care Manager who was also a registered nurse. The intervention covered a set compendium of pain education topics. The largest group of participants who did not obtain Naloxone in the study felt it was unnecessary. One large, unifying theme expressed by these participants was that they had taken their medication for a significant period of time in a responsible manner. Their inference that they would not be at risk for opioid overdoes represents a form of Optimism bias. Only a fraction of the 1 h care management meeting (4–6 min) was spent discussing Naloxone. An increase in that amount of time, or an increase in the frequency of education meetings could have persuaded more patients to attain Naloxone, and could have been an excellent reminder to those who had forgotten about it. An additional limitation was the cost of Naloxone. The cost of Naloxone during the time of data collection, in the study’s location, ranged from US $26.62 for an injectable form of Naloxone, up to US $105.00 for the intranasal variety. Insurance coverage varied from no change in price down to fully covered, with a US $0 copay. Care management programs like this could increase the public awareness of Naloxone and shed light on the cost of this opioid antagonist. Access was also considered a limitation of this study. Only having 2.6% of the entire study population consider access as a barrier would lead to the belief that Naloxone was readily available. However, after removing the 101 participants who never attempted to attain Naloxone (forgot, considered unnecessary), then 4 of the remaining 52 participants (7.7%) considered access to Naloxone an issue. If care management programs like this increase the demand for Naloxone, pharmacies would likely obtain Naloxone for distribution. A significant strength of this study was the response rate of 94.9%, with almost all patients approached consenting to participate. What this study adds This research investigated whether the addition of one-on-one chronic pain care management, delivered by a nurse, to usual care would increase the procurement of Naloxone. This study is an example of how a primary care team can significantly affect care with a relatively small intervention. The increased attainment rate of Naloxone by 288% suggested this intervention to be effective. The absolute increase from 5.2 to 25.4% illustrates the need for additional effort in this area. Further interactions (family member involvement, phone reminders, email updates, follow-up appointments) could be studied to determine whether these interactions increase the attainment of Naloxone. References 1 Beletsky L, Rich JD, Walley AY. Prevention of fatal opioid overdose. J Am Med Assoc 2012; 308: 1863– 4. Google Scholar CrossRef Search ADS 2 Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. J Am Med Assoc 2016; 315( 15): 1624– 45. Google Scholar CrossRef Search ADS 3 Kroenke KMD, Cheville AMD. Management of chronic pain in the aftermath of the opioid backlash. J Am Med Assoc 2017; 317( 23): 2365– 6. Google Scholar CrossRef Search ADS 4 Hasegawa K, Espinola JA, Brown DF et al. . Trends in U.S. emergency department visits for opioid overdose, 1993–2010. Pain Med 2014; 15: 1765. Google Scholar CrossRef Search ADS PubMed 5 Substance Abuse and Mental Health Services Administration, Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits. HHS Publication No. (SMA) 13-4760, DAWN Series D-39. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013. 6 Dart RC, Surratt HL, Cicero TJ et al. . Trends in opioid analgesic abuse and mortality in the United States. N Engl J Med 2015; 372: 241. Google Scholar CrossRef Search ADS PubMed 7 Unick GJ, Rosenblum D, Mars S et al. . Intertwined epidemics: national demographic trends in hospitalizations for heroin-and opioid-related overdoses, 1993-2009. PLoS One 2013; 8: e54496. Google Scholar CrossRef Search ADS PubMed 8 Hedegaard H, Chen LH, Warner M. Drug-poisoning deaths involving heroin: United States, 2000–2013. NCHS Data Brief 2015; 273: 1. 9 Rudd RA, Paulozzi LJ, Bauer MJ et al. . Increases in heroin overdose deaths—28 States, 2010 to 2012. MMWR Morb Mortal Wkly Rep 2014; 63: 849. Google Scholar PubMed 10 Wheeler E, Jones TS, Gilbert MK et al. . Opioid overdose prevention programs providing naloxone to laypersons—United States, 2014. MMWR Morb Mortal Wkly Rep 2015; 64: 631– 5. Google Scholar PubMed 11 Schneiderhan JMD, Clauw DMD, Schwenk TMD. Primary care of patients with chronic pain. J Am Med Assoc 2017; 317( 23): 2367– 8. Google Scholar CrossRef Search ADS 12 CDC Report MMWR. February 17, 2012; vol. 61(06): pp. 101–5. 13 Gupta R, Shah ND, Ross JS. The rising price of Naloxone—risks to efforts to stem overdose deaths. N Engl J Med 2016; 375: 2213– 5. Google Scholar CrossRef Search ADS PubMed 14 Exploring Naloxone Uptake and Use—a Public Meeting. Silver Spring, MD: Food and Drug Administration, July 1–2, 2015 (http://www.fda.gov/Drugs/NewsEvents/ucm442236.htm). 15 Barbor TF, Higgins-Biddle JC. World Health Organization. Dept. of Mental Health and Substance Dependence, Brief Intervention of Hazardous and Harmful Drinking: A Manual for Use in Primary Care . Geneva: World Health Organization, 2001. 16 Miller WR, Rollinick S. Motivational Interviewing: Preparing People to Change Addictive Behavior . New York and London: Guilford Press, 2002. 17 Saunders B, Wilkinson C, Phillips M. The impact of a brief motivational intervention with opiate users attending a methadone programme. Addiction 1995; 90( 3): 415– 24. Google Scholar CrossRef Search ADS PubMed 18 Group WBIS. A cross-national trial of brief interventions with heavy drinkers. Am J Public Health 1996; 86( 7): 948– 55. Google Scholar CrossRef Search ADS PubMed 19 Hester RK, Miller WR. Handbook of Alcoholism Treatment Approaches. ; Vol. 3. Boston, MA: Allyn and Bacon, 2003. 20 McNemar Q. Note on the sampling error of the difference between correlated proportions or percentages. Psychometrika 1947; 12( 2): 153– 7. https://www.ncbi.nlm.nih.gov/pubmed/20254758. https://doi.org/10.1007%2FBF02295996. Google Scholar CrossRef Search ADS PubMed 21 Wheeler E, Davidson P, Stephen Jones T et al. . Community-based opioid overdose prevention programs providing Naloxone—United States, 2010. MMWR Morb Mortal Wkly Rep 2012; 61( 6): 101– 5. Google Scholar PubMed 22 Walley AY, Xuan Z, Hackman HH et al. . Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: interrupted time series analysis. Br Med J 2013; 346: f174. Google Scholar CrossRef Search ADS © The Author(s) 2018. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: firstname.lastname@example.org
Journal of Public Health – Oxford University Press
Published: Feb 16, 2018
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