Opioid Dosing Simulator
Opioids have been used for generations to treat pain, yet as a class of medications, they rank high on lists of drugs associated with adverse events, including events that result in harm. As part of a 5-year grant from the Agency for Healthcare Research and Quality, Dr. Lambert with other researchers is investigating issues related to opioid prescribing and pain control in inpatient care by testing the use of an opioid simulator as part of resident training.
Residents do not get well trained in how to use opioids, says principal investigator Bruce Lambert, PhD. They are either scared to use them, so they use too little, or they are afraid of their patients’ being in pain, so they use too much. Dr. Lambert and his team are researching whether residents who receive training on the simulator, in addition to formal didactic teaching, will be more confident in prescribing pain medications and whether their patients will report better pain scores during their hospitalizations.
Among those working with Dr. Lambert are William Galanter, MD, PhD, medical director of the UIC CERT; Diana Wilkie, RN, PhD, FAAN, a nurse scientist and pain expert; and Robert McNutt, MD, who created the first version of the computer-based opioid simulator while serving as chief of patient safety at Rush University Medical Center.
DEVELOPING TOOLS TO PROMOTE MEDICATION SAFETY
REFERENCE - National Patient Safety Foundation: www.npsf.org/updates-news-press/top-meds-developing-tools-to-promote-medication-safety/print/
A hospitalized patient receiving opioids for pain may have little in common with a patient in a primary care clinic who is struggling to control diabetes mellitus. Yet these vastly different clinical scenarios are similar in one significant way: In both cases, there is a strong risk that medication is not being optimally prescribed or taken, with the result being less-than-optimal outcomes and, perhaps, gaps in patient safety.
These problems are also part of the focus of a $4.25 million, five-year contract awarded last fall by the Agency for Healthcare Research and Quality as part of the Centers for Education and Research on Therapeutics (CERTs) program. Led by Bruce Lambert, PhD, professor of pharmacy administration and director of the CERT at the University of Illinois at Chicago, the Tools for Optimizing Medication Safety (TOP-MEDS) project has broad goals for improving the prescribing of opioids; reducing drug name confusion; enhancing post-marketing surveillance of adverse drug events; and improving patients’ understanding of and compliance with drug regimens.
We set out to address unambiguously big, important problems. We wanted to work on projects that had a very high likelihood of success in five years.
The CERTs program was started as part of the Food and Drug Administration Modernization Act of 1997. Its mission is to “increase awareness of the benefits and risks of new, existing, or combined uses of therapeutics. That includes medications, medical devices, and biological products. The TOP-MEDS CERT is one of six research centers in the country to receive funding in the latest round and the only one focused exclusively upon patient safety. The others are at Duke University Medical Center (cardiovascular therapeutics), Rutgers University (mental health therapeutics), Brigham and Women’s Hospital (health information technology), University of Alabama at Birmingham (musculoskeletal disorders), and Cincinnati Hospital Children’s Medical Center (pediatric therapeutics). There is also a coordinating center, the CERTs Scientific Forum, to lead scientific collaborations of all six CERTs Research Centers; it is based at the Kaiser Foundation Center for Health Research in Portland, OR.
The current projects grew from prior research in these areas. For example, Lambert first began researching drug-name confusion in 1998 with a grant from the National Patient Safety Foundation. This current project is a direct continuation of that line of research. If you look at data on medication errors, wrong drug errors account for about 8 percent. Even when we know which names are likely to be confused, the errors just keep happening.
Yet, beyond adding to the pool of knowledge, the TOP-MEDS program also plans to deliver tools that can be applied in practice. For example, Robert Gibbons, PhD, statistical director for the program, whom Lambert calls “one of the foremost biostatisticians in the world, is involved in a project to develop a new statistical model for analyzing large observational databases of adverse drug events. We aim to have a statistics program that we can give away for free. We’ll produce good research papers, but we will embody the methods in tools that others can put to use.
TOP-MEDS has four main areas of research:
- Developing a model for large-scale adverse drug event screening that will surpass spontaneous reporting and detect ADEs not noted in pre-approval clinical trials.
- Developing a web-based simulation program to train clinicians in the proper selection and dosing of opioids to improve the safety and effectiveness of acute pain control in inpatients.
- Developing and testing methods of preventing and detecting drug-name confusion both pre-approval and post-approval.
- Evaluating low-literacy materials and the use of electronic health records to promote safe and effective use of medications among English and Spanish-speaking patients in an urban primary care practice.
We hope to make a meaningful, incremental contribution in these areas. We’re modest about the impact we can have, but we hold ourselves accountable to make a contribution. We owe the public a substantial return on their investment.
Also collaborating on the project are Dr. Bill Galanter, clinical director, and a number of co-investigators from Rush University Medical Center; Northwestern University; University of Chicago; and Brigham and Women’s Hospital, Boston. The Institute for Safe Medication Practices, Horsham, Penn.; and the National Patient Safety Foundation, Boston, are subcontractors and partners in dissemination of results and findings.
We are proud to be a partner in such a rigorous program that is also characterized by innovative uses of technology and a focus on patient-centeredness, says Diane C. Pinakiewicz, MBA, president of NPSF.
Lambert will be among the faculty at the NPSF Patient Safety Congress this coming May, presenting a breakout session that will focus on the CERTs patient safety work. As the TOP-MEDS project progresses, he and his team plan subsequent presentations at the annual Congress.
SPECIFIC AIMS AND STUDY HYPOTHESES
The long term objective of this project is to improve the safety and effectiveness of pain care for hospitalized patients with acute or acute on chronic pain. The short term objective is to develop and test a method for training hospital-based practitioners in principles of safe and effective pain care.
We will achieve these objectives by carrying out studies with the following specific aims: (1) to refine and port to the Web an existing computer-based simulation training tool that allows clinicians to learn the relationship between opioid selection and dosing and resulting changes in the trajectory of pain scores; (2) to identify and refine measures of opioid-related adverse drug events (ADEs) in the hospital setting; and (3) to compare the effect of didactic education plus simulation training versus didactic training alone on the safety and effectiveness of inpatient pain care.
We hypothesize that in comparison with patients whose doctors receive didactic training alone, patients whose doctors receive didactic plus simulation training will 1) demonstrate more effective treatment of acute pain requiring opioids (2) have fewer opioid-related adverse drug events (ADEs).
BACKGROUND AND SIGNIFICANCE
Acute pain care is dangerous and ineffective
Hospitalized patients often suffer from acute pain, but treatment of pain in the hospital is suboptimal. Studies and guidelines for pain care are especially lacking for general medical patients.6 Opioids are the primary agents used to treat acute pain in hospitals, but opioid prescribing exhibits well-documented patterns of overuse and underuse, with the added variable that opioids are known to be among the highest risk class of medications for causing patient harm.Among other adverse effects, opioids can cause sedation and respiratory depression as well as increase the risk for slowed GI function and urinary retention. According to a recent analysis of AHRQ’s HCUP database, opiates were the fourth most common cause of inpatient adverse drug events (ADEs), accounting for . 6% of all inpatient ADEs (121,200 events in 2008) and the rate would be even higher if represented as proportion of serious harm events. The HCUP analysis relied on ICD9 codes to identify ADEs, but claims-based measures significantly undercount adverse events. The actual opioid-related ADE rates are probably much higher. Patients who experienced such events had significantly higher mortality and longer lengths of stay than those who did not. At the opposite extreme, underuse results in inadequate pain relief, and causes patients to suffer needlessly. The undertreatment of pain is extensively documented in the literature, and published acute pain care guidance documents underscore the importance of more adequately recognizing and treating pain. A review of a national experience reported to MedMarx finds opioids associated with both frequent and severe ADEs. Opioids as a class contribute 25% of adverse events reported, as many reports as anti-infective agents and anticoagulants combined. The reported adverse events were balanced between over and under dosing. Thus, acute pain care, especially in relation to opioid analgesics, represents a classic clinical dilemma, a double edged sword where both undertreatment and overtreatment cause significant harm. This is both an important problem in its own right and is representative of a central paradigm in therapeutics.
Improving pain care has resisted traditional training modalities
Barriers to ideal pain care include patient factors (reluctance to report pain; fear of addiction), physician factors (fear of overdose, addiction and lawsuits), health system issues (low priority), and inadequate assessment of pain. Widespread promulgation of clinical care guidelines has not significantly improved the quality of pain care. In a 22-site team-training collaborative, the accuracy of pain assessment, the presence of a care plan and pain care education were associated with only a modest decline in the percentage of patients reporting moderate/severe pain (from 24% to 17%).11 Hospitalcompare.hhs.gov reports that on average only 69% of hospital patients state their pain is well controlled all of the time. The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment (SUPPORT) found that one in seven terminal patients report having severe pain half of the time and another 15% considered pain management inadequate.12 The Joint Commission monitors health care sites for the quality of pain assessment, but more frequent measurement of pain with a 1-10 analog scale has not led, by itself, to safer care. Some institutions have monitored patients’ outcomes of pain care before and after implementing the Joint Commission standards and found unintended adverse events.13 While some studies noted a modest improvement in satisfaction with pain control, they found that over sedation and adverse drug reactions increased more than twofold, concluding that a strategy beyond focusing on pain measurement was needed. A recent evidence-based report from the National Cancer Institute further supports the need for a better model of safe care in patients with cancer related pain. After reviewing over 200 randomized trials, they concluded that there is no established optimal treatment plan.14
Simulation-based training can be effective where traditional training fails
In teaching hospitals, caregivers strive to balance the seemingly opposing goals of training new health professionals while consistently delivering safe and effective medical care. Simulation provides the trainee with an opportunity to practice skills without risk of patient harm, and, therefore, has appeal for reasons of patient safety, educational quality, cost-effectiveness and medical ethics. Modern technology has enabled the development of myriad sophisticated simulators for the practice of complex skills.15
Outpatient addiction and dependence
In outpatient settings around the world, intentional abuse of opioids, addiction, and accidental overdose have grown into an epidemic.16 Our intervention is focused on the safe and effective use of opioids for inpatients, but because training emphasizes rapid transition from IV to long acting opioids, and because many patients will be discharged on long-acting agents, our work will impact and be impacted by the new federal initiative to manage the outpatient opioid addiction epidemic. We will not only comply with all aspects of the new opioid risk evaluation and mitigation strategies (REMS), but will also strive to design our training programs to better inform and meet the training requirements laid out in the new long-acting opioid REMS, and thereby advance the state of the art in this important and problem prone area of medication use.16
We have developed and pilot tested a pain care simulator for use in training.17, 18 This pain care simulator is the first and only one of its kind (although one publication has appeared recently reporting the use of a mannequin-based high-fidelity simulator to teach opioid pharmacology).19 An important innovative aspect of our simulator is that it does not train students in a real-time or even near-real time, in contrast to the vast majority of simulators. Instead, it explicitly compresses time. Given the simulated patient’s dosage history and current pain score, the trainee chooses whether to administer medication, and if so what dose and type of formulation, and then obtains instantaneous feedback on the effect of long-acting medications, projected up to 41 hours into the future. In clinical training or in real-time simulation, the trainee would continue other tasks and return to the (actual or simulated) patient at the appropriate hour. Without the usual clinical distractions and interruptions in both care and learning, time compression allows the trainee to focus on how to assess a patient’s sensitivity to pain medications and how best to provide pain relief. Time compression supports identified best practices for simulation such as deliberate practice, which may be unavailable in real time training. Our simulator’s ability to compress time offers an innovative way to improve educational efficiency and efficacy, and numerous other conditions with long-acting medications, such as blood glucose management for diabetic patients or antihypertensive management, may similarly benefit. The proposed work will advance our understanding of this capability, thereby improving our understanding of the strengths and limitations of simulation in healthcare. Also innovative is our focus on general medical patients. In comparison to surgical, cancer and sickle cell disease pain, there are no current pain management guidelines for general medical patients, and much less is known in general about pain care for this population.6 Our work will contribute to better pain care for general medical patients.
Aim 1: Refining the simulator and porting it to the web
Our first specific aim is to refine and port to the web an existing computer-based simulation training tool that allows clinicians to learn the relationship between opioid selection and dosing and resulting changes in the trajectory of pain scores
The simulator currently exists as a Microsoft Excel extension written in Visual Basic. It runs in a desktop environment on any system that runs Excel. We will transfer a copy of the program to our programming subcontractor, Discerning Systems, who will then begin the process of re-writing the simulator as a web-based application. It is possible that we will do systematic user testing on the web-based version of the simulator at a later date. If and when we do, we will submit either an amendment or a separate protocol to cover the user testing. Otherwise, the porting of the simulator to the web does not involve human subjects.
Aim 2: Refining measures of opioid-related adverse events in the hospital.
Our eventual goal (in Aim 3 below) is to demonstrate the effect of simulation training on the effectiveness and safety of opioid prescribing. To measure the effect of simulation training, we first need valid and reliable measures of inpatient opioid-related ADEs. Development and validation of these measures is the main activity of Aim 2. Thus, our second specific aim is to identify and refine measures of opioid-related adverse drug events (ADEs) in the hospital setting.
Results and Deliverables
According to Dr. Lambert, the simulator itself is based on a relatively simple concept. The project takes on added complexity in the measurement and analysis of data. Although the team will rely on patients’ pain scores and the trend of those scores throughout hospitalization, they will also survey electronic medical record data for evidence of ADEs and conduct chart reviews to validate whether errors occurred.
Additionally, this project involves translating the opioid simulator program to applications that can be used on tablet and mobile devices. The team is working with Discerning Systems, Inc., a company that specializes in designing graphical user interfaces across platforms.
The researchers are excited about the potential impact of this project. If we can prove our hypothesis, and if simulation can be easily web-based, it could help a lot of patients, notes Dr. Galanter.