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February 18, 2020
More Nudges
We learned a lesson from commercial laboratories many years ago. Those commercial labs made their money, of course, by doing more tests. So, they packed their order forms for tests in a manner that made it most easy for clinicians to check as many boxes as possible.
So, when we recognized at our hospital that many tests were either unnecessarily repetitive or of low value, we changed our own lab and radiology requisition forms (paper at the time) to remove from the front of the form those tests that were of low value. We also looked at all our standardized order sets and saw the same pattern. Those order sets that offered checkboxes for “prn” medications almost always invited checking boxes.
And, when we did our first electronic medical record implementation, we were extremely concerned that design of various screens and menus could make it too easy to order things that might not be absolutely necessary. We discussed that in our March 23, 2010 Patient Safety Tip of the Week “ISMP Guidelines for Standard Order Sets”. We noted that order sets often included prn orders for sleep meds, laxatives, antacids, etc. Often, these were included so a clinician did not have to be awakened at night to order such medications. ISMP’s guideline on order sets also cautioned against including blanket-type orders (eg. laxatives, sleep meds, antiemetics, antidiarrheals, antacids, etc).
Conversely, you can use form design to “nudge” clinicians to remember to do certain things, like assessing DVT risk and considering DVT prophylaxis.
We’ve done several columns on how use of “nudges” can increase the likelihood of the most desirable action occurring. But sometimes nudges can be in the wrong direction. That is, they push you to do something that may actually be detrimental or at least not the best course of action. We discussed these issues in our July 23, 2019 Patient Safety Tip of the Week “Order Sets Can Nudge the Right Way or the Wrong Way”.
A recent study looked at the impact of default settings for opioid prescribing in the emergency department (Montoy 2020). The researchers randomly altered the default settings for quantities of opioid tablets. These changes were made without announcement, and prescribers were not informed of the study itself. They found that an increase of 0.19 tablets prescribed was found for each tablet increase in default quantity. They conclude that this low-cost, easily implementable, EMR-based intervention could have far-reaching implications for opioid prescribing and could be used as a tool to help combat the opioid epidemic.
Chin and colleagues (Chin 2018) demonstrated similar findings for postprocedural prescribing of opioids. The electronic medical record (EMR) can autopopulate a default number of pills prescribed, and 1 potential method to alter prescriber behavior is to change the default number presented via the EMR system. In a multi-hospital system, they reduced the default number of opioid pills autopopulated in the EMR when prescribing discharge analgesia from 30 to 12. Clinicians could still alter the number of pills prescribed to any amount they deemed necessary. After the default change, the median number of opioid pills prescribed decreased from 30 to 20. The percentage of prescriptions written for 30 pills decreased from 39.7% before the default change to 12.9% after the default change, and the percentage of prescriptions written for 12 pills increased from 2.1% before the default change to 24.6% after the default change. This occurred without significant change in opioid refill rates. This translated to a decrease of 5.22 opioid pills per prescription and a total decrease of 34.41 morphine milligram equivalents (MME’s) per prescription. The authors concluded this is a simple, effective, cheap, and potentially scalable intervention to change prescriber behavior and decrease the amount of opioid medication prescribed after procedures.
Another recent study used an EMR “nudge” to reduce inappropriate orders for C. diff testing (Howard-Anderson 2020). Orders for hospital-onset C. difficile infection testing in patients administered a laxative or stool softener in <24 hours triggered an EMR alert defaulting to cancellation of the order (“nudge”). Orders considered inappropriate for C. diff testing decreased from 8% to 6% after implementation of the “nudge”. Total monthly orders decreased by 21% postintervention.
In our April 30, 2019 Patient Safety Tip of the Week “Reducing Unnecessary Urine Cultures” we noted how clinicians and researchers at Barnes-Jewish Hospital implemented a program to reduce unnecessary cultures (Munigala 2019). Their intervention consisted of notifications to providers, changes to order sets, and inclusion of urine culture reflex tests in commonly used order sets. The CPOE intervention they implemented was setting the default option to urine dipstick testing followed by a bacterial culture if positive (i.e. reflex testing), rather than a culture alone, This resulted in a 45% reduction in the urine cultures ordered. That intervention saved approximately $104,000 in laboratory costs alone over the 15-month period plus likely savings from reduced antibiotic use and less contribution to the emergence of resistant organisms.
Note that the “nudge” need not necessarily go to the physician. Another innovative intervention from the PennMedicine Nudge Center imcreased screening rates for breast cancer and colorectal cancer 22 percent and 14 percent, respectively (Hsiang 2019). The intervention was an active choice intervention in the electronic health record that prompted medical assistants to inform patients about cancer screening during check-in and template orders for clinicians to review during the visit. Unfortunately, there were minimal changes in the rates of patients who followed through within one year and completed their screenings. Perhaps a “nudge” at the patient level is necessary as well. But the study demonstrated that we can reduce the risk of alert fatigue for physicians by sending the alerts to other members of the healthcare team. We’ve previously noted that some alerts might be sent to pharmacists rather than directly to physicians.
Most of the examples above are aimed at overcoming one of the most powerful cognitive biases, the “default bias”. That bias demonstrates our natural tendency to select default options when several options are possible. Two related cognitive biases are the “inertia bias” and the “status quo bias”, both of which encourage us to keep doing something. (Remember that monthly fee for software you seldom use anymore that you keep forgetting to cancel?). We discussed these in our July 7, 2009 Patient Safety Tip of the Week “Nudge: Small Changes, Big Impacts”. The study by Chin et al. (Chin 2018) also raised the role of yet another cognitive bias, “anchoring”, to the result produced by the new default. “Anchoring reflects the idea that human adjustments of estimates are based on a given starting value. In this case, estimates of the number of opioid pills needed for analgesia were anchored around the default number of pills presented, and a new, lower anchor helped decrease overall prescribing.”
Nudges can also be valuable in steering medication ordering in a desirable way. A study by Patel et al. (Patel 2016) found that a change in the EMR default to generics instead of brand names resulted in prescribing rates for generics increasing from 75% to 98%.
In another study, Patel and colleagues (Patel 2018) found that nudges which asked clinicians to make an active choice on statin prescriptions and delivered feedback on how each clinician’s performance compared to their peers led to a significant increase in statin prescription rates. Physicians received an email with a link to an online information “dashboard” listing their patients who were eligible for statin therapy but not already receiving it. One group of physicians also received a note comparing their rate of prescribing statins for eligible patients to other doctors in relevant specialties. Physicians in both intervention groups were asked to review the list of patients and use a multi-choice menu to prescribe a statin for each one or indicate a reason for non-prescribing. Results were compared to a third group that received no “dashboard” list and no comparison feedback.
The “dashboard” listed each of their patients along with their age, sex, and the following data as available from the EHR: 10-year ASCVD risk score, most recent LDL-C level, other lipid levels, body mass index, history of smoking and any form of clinical ASCVD (eg, myocardial infarction or stroke), liver function tests, and medical record number. The PCPs were asked to review the list of patients within 1 week and use the dashboard to select whether or not to prescribe each patient a statin. The dashboard provided an overview of the study, a link to the American College of Cardiology/American Heart Association guidelines, and options for selecting statin dosage.
Compared with usual care, there was a significant increase in statin prescribing in the active choice with peer comparison arm (adjusted difference in percentage points, 5.8), but not in the active choice arm.
The authors felt that a key element of their intervention design was active choice framing. Physicians could review patients using the automated patient dashboard and make decisions on statin prescriptions. By offering multiple options to prescribe a guideline-indicated statin and requiring a reason to say no, clinicians may be nudged toward prescribing a statin. Peer comparison feedback delivered just once by email was effective at increasing physician engagement with the automated patient dashboard. One advantage of this approach is that it does not require waiting for a patient to come to the clinic to make a decision. It also might optimize future clinic visits by removing the identification of eligible patients and process of prescribing so that the physician and patient can focus more on other aspects of care. A potential downside is that physicians with larger patient panels may face difficulties managing these types of decisions outside of their traditional clinic model when they receive a long list of eligible patients.
Mitesh S. Patel, M.D., head of Penn Medicine’s “Nudge Unit”, and colleagues wrote an informative review on nudges in the New England Journal of Medicine (Patel 2018b). They describe nudges as ways of presenting choices in ways that strongly influence consumer behavior. They give some great practical examples from everyday life. Airlines require consumers to actively choose whether to purchase trip insurance before they can buy a plane ticket. Amazon displays additional, complementary items alongside the purchase you are about to make. Video streaming sites often use default settings to automatically play the next episode in a TV series to encourage binge watching.
They go on to describe how nudges can be designed to remind, guide, or motivate behavior in healthcare. They suggest targeting areas in which suboptimal care can be addressed by targeting a specific decision that drives a less-than-optimal behavior. For example, when prescribing medications, physicians must decide between brand-name and generic formulations. They cite the study we noted above (Patel 2016) that found a change in the EMR default to generics instead of brand names resulted in prescribing rates for generics increasing from 75% to 98%.
They note suboptimal referral of eligible patients for cardiac rehabilitation after myocardial infarction may have resulted from an opt-in system. So, they redesigned he process as an opt-out system in which referral for rehab was the default. The referral rate increased to more than 80%.
Thoughtful design of order entry screens and standardized order sets is important in helping physicians make correct choices and avoid less optimal ones. An editorial by Vaughn and Linder (Vaughn 2018) discussed how “nudges” may be helpful. They note some designs provide a stimulus to do the wrong thing. For example, simply providing a checkbox may nudge a physician to check that checkbox. Providing the brandname of a drug may nudge the physician to order the more expensive formulation rather than a generic equivalent. And allowing a test to be ordered repetitively (eg. “daily CBC”) may lead to inappropriate testing.
They suggest the following questions be asked during design of order sets or order entry screens:
They stress the strong effect of using appropriate default settings, citing the study mentioned above (Munigala 2018) that successfully reduced inappropriate urine cultures in an emergency room by changing the default option from “urinalysis with reflex to urine culture” to “urinalysis with reflex to microscopy”.
Of course, there are other interventions that can be used to reduce the amount of unnecessary tests. Education and audit and feedback may modestly reduce the ordering of “routine” tests. A recent study (Ambasta 2020) found an 11% reduction in “routine” lab tests ordered in an academic setting when residents were given education and feedback with comparison to peers and attending internists were given feedback with comparison to peers.
But education and training always rank low in our hierarchy of effective interventions. In our January 2020 What's New in the Patient Safety World column “ISMP Canada: Change Management to Prevent Recurrences” we noted the excellent editorial by Soong and Shojania “Education as a low-value improvement intervention: often necessary but rarely sufficient” (Soong 2019). It describes several scenarios and how education fits in with each. In our brief illustrative Power Point “RCA Strong vs. Weak Responses” we show education and training as the weakest actions. We don’t include “nudges” in that hierarchy because that list actually applies to RCA actions. But nudges would probably fit somewhere near the middle of a list of action effectiveness.
The strongest actions are forcing functions and constraints. How about this for an effective constraint: Don’t Pay for It! In a study on low-value tests, Henderson et al. (Henderson 2020) looked at the impact of Choosing Wisely recommendations for vitamin D testing in Canada and the US. These resulted in 4.5% and 14.5% reductions in testing in Ontario and the US, respectively. But Ontario implemented a payment policy change that eliminated reimbursement of vitamin D screening. That was associated with a 92.7% relative reduction in such screening!
To be effective, any “nudge” needs to be inexpensive to implement, nonobtrusive to the clinician, and provide useful information that helps lead to active choices. You need to be very wary you don’t simply create “noise” that leads to alert fatigue. Equally important is to establish a method by which you will evaluate whether the nudge actually produced desired results and, just as importantly, did not produce any unintended consequences.
In sum, we think nudges are a great way to help change clinician behavior. They can usually be implemented inexpensively and in a minimally obtrusive manner. They have a definite role in our armamentarium of interventions. But we should always continue to look for stronger interventions that might have a greater impact when feasible.
See some of our other columns dealing with “nudges”:
References:
Montoy JCC, Coralic Z, Herring AA, Clattenburg EJ, Raven MC. Association of Default Electronic Medical Record Settings With Health Care Professional Patterns of Opioid Prescribing in Emergency Departments: A Randomized Quality Improvement Study. JAMA Intern Med 2020; Published online January 21, 2020
https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2759133
Chin AS, Jean RA, Hoag JR, et al. Association of Lowering Default Pill Counts in Electronic Medical Record Systems With Postoperative Opioid Prescribing. JAMA Surg 2018; Published online July 18, 2018
Howard-Anderson JR, Sexton ME, Robichaux C, et al. The impact of an electronic medical record nudge on reducing testing for hospital-onset Clostridioides difficile infection. Infection Control and Hospital Epidemiology 2020; Published online February 10, 2020
Munigala S, Rojek R, Wood H, et al. Effect of changing urine testing orderables and clinician order sets on inpatient urine culture testing: Analysis from a large academic medical center. Infection Control and Hospital Epidemiology 2019; Published online: 21 February 2019: 1-6
Hsiang EY, Mehta SJ, Small DS, et al. Association of an Active Choice Intervention in the Electronic Health Record Directed to Medical Assistants With Clinician Ordering and Patient Completion of Breast and Colorectal Cancer Screening Tests. JAMA Netw Open 2019; 2(11) :e1915619
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2755489?resultClick=1
Patel MS, Day SC, Halpern SD, et al. Generic Medication Prescription Rates After Health System–Wide Redesign of Default Options Within the Electronic Health Record. JAMA Intern Med 2016; 176(6): 847-848
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2520677
Patel MS, Kurtzman GW, Kannan S, et al. Effect of an Automated Patient Dashboard Using Active Choice and Peer Comparison Performance Feedback to Physicians on Statin Prescribing: The PRESCRIBE Cluster Randomized Clinical Trial. JAMA Netw Open 2018; 1(3): e180818
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2688535?resultClick=3
Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care
N Engl J Med 2018; 378: 214-216
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6143141/
Vaughn VM, Linder JA Thoughtless design of the electronic health record drives overuse, but purposeful design can nudge improved patient care. BMJ Qual Saf 2018; Published Online First: 24 March 2018
http://qualitysafety.bmj.com/content/early/2018/03/24/bmjqs-2017-007578
Ambasta A, Ma IWY, Woo S, et al. Impact of an education and multilevel social comparison–based intervention bundle on use of routine blood tests in hospitalised patients at an academic tertiary care hospital: a controlled pre-intervention post-intervention study. BMJ Quality & Safety 2020; Published Online First: 10 February 2020
https://qualitysafety.bmj.com/content/early/2020/02/10/bmjqs-2019-010118
Soong C, Shojania KG. Education as a low-value improvement intervention: often necessary but rarely sufficient. BMJ Quality & Safety 2019; Published Online First: 16 December 2019
https://qualitysafety.bmj.com/content/early/2019/12/16/bmjqs-2019-010411
Our Power Point: RCA - Strong vs. Weak Responses
http://patientsafetysolutions.com/docs/RCA_strong_vs_weak_responses.ppt
Henderson J, Bouck Z, Holleman R, et al. Comparison of Payment Changes and Choosing Wisely Recommendations for Use of Low-Value Laboratory Tests in the United States and Canada. JAMA Intern Med. Published online February 10, 2020
https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2760344
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February 2020
Staph aureus has long been a leading cause of nosocomial infections in neonatal intensive care units (NICU’s). Attempts to reduce transmission of Staph aureus from any source would be welcome. Parents of neonates are one of those potential sources. The TREAT PARENTS (Treating Parents to Reduce Neonatal Transmission of Staphylococcus aureus) trial (Milstone 2019) has now demonstrated that treatment of parents colonized with Staph aureus with intranasal mupirocin and chlorhexidine-impregnated cloths compared with placebo significantly reduced neonatal colonization with an Staph aureus strain concordant with a parental baseline strain. This was a double-blinded randomized clinical trial conducted in 2 NICU’s.
Colonization with parental strains of Staph aureus strain occurred in 14.6% of neonates in the intervention group versus 28.7% in the control group.
Minor adverse events that occurred in treated parents were mostly mild skin irritation or nasal congestion and no major adverse events occurred in treated parents.
The study is considered to be preliminary and should seek replication in other settings. Also, because of low numbers of patients, the study was not able to demonstrate that their findings translate to a reduction in symptomatic Staph aureus infections in the neonates. Nor was it powered enough to show that mortality or NICU length of stay (LOS) were impacted by the intervention. The cost effectiveness was not noted but the cost of the intervention was likely low. Those are good questions for larger, multicenter studies. But, certainly, the results of TREAT PARENTS are encouraging and should lead to further investigation.
References:
Milstone AM, Voskertchian A, Koontz DW, et al. Effect of Treating Parents Colonized with Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit: A Randomized Clinical Trial. JAMA 2019; Published online December 30, 2019
https://jamanetwork.com/journals/jama/fullarticle/2758295
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In multiple columns we have highlighted the dangers of long-acting and/or extended-release opioids (see especially our Patient Safety Tips of the Week for June 28, 2011 “Long-Acting and Extended-Release Opioid Dangers”, July 24, 2012 “FDA and Extended-Release/Long-Acting Opioids” and February 24, 2015 “More Risks with Long-Acting Opioids”, and our February 2017 What's New in the Patient Safety World column “FDA Approves Even More Long-Acting Opioids”).
These long-acting and extended-release opioid formulations are not intended for use as first-line agents in opioid-naïve patients. The newer opiate formulations are either more potent or designed to produce a longer peak action, two characteristics that lead to some of the greatest dangers. These have been designed to be used in patients who are opioid-tolerant and have pain of a chronic nature that has not been controlled with more conventional opiates. They were not intended to be used for treatment of acute pain nor to be used as first line agents in patients with pain. But in practice they are often being (mis)used in that way. And, unfortunately, these preparations became a prime driver of the opioid epidemic in the US.
Recognizing that ER/LA opioids were associated with greater risk of addiction, unintentional overdose and death than their immediate-release counterparts, the FDA in 2012 developed the concept of Risk Evaluation and Mitigation Strategy (REMS) programs. These were intended to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics.
So how did these REMS do? Not so good, according to a new study (Heyward 2019). Heyward et al. reviewed 9739 pages of FDA documents obtained through a Freedom of Information Act request. Their aim was to investigate whether the FDA and ER/LA manufacturers were able to assess the effectiveness of the ER/LA Risk Evaluation and Mitigation Strategy (REMS) program by evaluating manufacturer REMS assessments and FDA oversight of these assessments.
The documents show that the FDA’s REMS program was largely implemented as planned, and that tens of thousands of physicians took CE courses approved through the REMS, and that the courses generally included the content sought by the FDA.
The FDA’s goal was for 60% of ER/LA prescribers to take REMS-adherent continuing education (CE) between 2012 and 2016; Only 27.6% of prescribers had done so by 2016. Nonrepresentative cross-sectional surveys of self-selected prescribers suggested modestly greater ER/LA knowledge among CE completers than noncompleters, and claims-based surveillance indicated slowly declining ER/LA prescribing, although the contribution of the REMS to these trends could not be assessed.
The effectiveness of the REMS program for reducing adverse outcomes also could not be assessed because the analyses used nonrepresentative samples, lacked adequate controls for confounding, and did not link prescribing or clinical outcomes to prescribers’ receipt of CE training. Although the FDA had requested studies tracking adverse outcomes as a function of CE training, the FDA concluded that these studies had not been performed as of the 60-month report in 2017.
The authors conclude that, five years after initiation of the REMS program, the FDA and ER/LA manufacturers could not conclude whether the ER/LA REMS had reduced inappropriate prescribing or improved patient outcomes.
Retired FDA senior executive William Hubbard wrote the editorial accompanying the Heyward study (Hubbard 2019). He notes that actions at the federal level to combat the opioid epidemic have been “underwhelming”. He notes that more effective interventions are available, pointing to Florida’s restriction on prescribing. Florida had become known for its “pill mills”. In banned pain management clinics from dispensing drugs and established requirements for medical examinations and follow-ups before and after prescribing opioids for chronic pain. That resulted in a two-thirds reduction in pain clinics. Johnson et al. (Johnson 2014) described the multiple events that took place in Florida in response to a proliferation of pain clinics and a 61% increase in overdose death from 2003 to 2009. Pain clinic regulations were further expanded later in 2010. In February 2011, law enforcement conducted statewide raids, resulting in numerous arrests, seizures of assets, and pain clinic closures. In July of that year, coinciding with a public health emergency declaration by the Florida Surgeon General, the state legislature prohibited physician dispensing of schedule II or III drugs from their offices and activated regional strike forces to address the emergency. Mandatory dispenser reporting to the newly established prescription drug monitoring program began in September 2011. Finally, in 2012, the legislature expanded regulation of wholesale drug distributors and created the Statewide Task Force on Prescription Drug Abuse and Newborns.
Many states have implemented restrictions on prescriptions for opioids, for example, limiting initial prescriptions of opioids to a specified time period (eg seven days) for treatment of acute pain.
Long-acting and extended-release opioid preparations have clearly played a role in the opioid epidemic that has plagued the US. The crisis has been fed not only by an oversupply of opioids that often gets them into the wrong hands, but also by opioids being prescribed by healthcare professionals. Much of the FDA’s approach has been to focus on abuse-deterrent formulations to discourage abuse (see our February 2017 What's New in the Patient Safety World column “FDA Approves Even More Long-Acting Opioids”).
But our concerns over ER/LA opioid preparations extend well beyond just the issues of abuse, illicit use, and addiction. One significant factor related to the association between long-acting opioids and overdoses is dosage equipotency. The amount of morphine equivalents in these preparations is typically higher than that found in most short-acting formulations and many prescribers are not appreciative of this. Of course, the issue of dose is not unique to the long-acting opioids. We’ve highlighted the same problem with HYDROmorphone in our September 21, 2010 Patient Safety Tip of the Week “Dilaudid Dangers” and the other columns on HYDROmorphone safety issues listed below. It is also problematic that when switching from short-acting opioids to long-acting or extended-release opioids it is very common to see misunderstandings of the relative potencies of the various opiate preparations.
We’ve also seen patients develop delayed-onset coma after attempting suicide. If the specific formulation they took is unknown, they may be evaluated in an ER prior to admission to a behavioral health unit, at which time they lack clinical signs of opioid intoxication and may have very low toxicology levels. They are given “medical clearance” and admitted to the behavioral health unit. Overnight they get further release of the opioid into their bloodstream and the following morning they may be comatose.
Another important issue for these long-acting and extended release opioids is the phenomenon of re-narcotization. The effect of the reversal agent naloxone may wear off long before the effect of the opioid wears off, raising the danger of recurrence of respiratory depression.
We’ve also seen rare cases in which patients on these long-acting opioid formulations have developed acute opioid withdrawal symptoms following naloxone injections.
Note that long-acting opioid formulations (particularly those in transdermal patches) are also now frequent causes of accidental overdoses, including those for whom they were not prescribed such as children and pets (see our September 13, 2011 Patient Safety Tip of the Week “Do You Use Fentanyl Transdermal Patches Safely?” and our May 2012 What’s New in the Patient Safety World column “Another Fentanyl Patch Warning from FDA”).
These are all issues that should be addressed in the ER/LA REMS programs, but not all of them are. We find it particularly bothersome that the Heyward study has shown that, five years after initiation of the REMS program, the FDA and ER/LA manufacturers could not conclude whether the ER/LA REMS had reduced inappropriate prescribing or improved patient outcomes.
Our prior articles pertaining to long-acting and/or extended release preparations of opioids:
Our prior columns on patient safety issues related to Dilaudid/HYDROmorphone:
Some of our other Patient Safety Tips of the Week regarding fentanyl and fentanyl patches:
References:
Heyward J, Olson L, Sharfstein JM, Stuart EA, Lurie P, Alexander GC. Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration: A Review. JAMA Intern Med 2019; Published online December 30, 2019
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2757791
Hubbard WK. Getting Serious About Opioid Regulation. JAMA Intern Med 2019; Published online December 30, 2019
https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2757786
Johnson H, Paulozzi L, Porucznik C, et al. Decline in Drug Overdose Deaths After State Policy Changes — Florida, 2010–2012. MMWR Morb Mortal Wkly Rep 2014; 63(26): 569-574; Published online July 4, 2014.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4584904/
Print “February 2020 The FDA and Long-Acting Opioids”
In our February 6, 2018 Patient Safety Tip of the Week “Adverse Events in Inpatient Psychiatry” we noted that, although deep venous thrombosis (DVT) is relatively rare on behavioral health units, every year state incident reporting systems receive reports of DVT or even fatal pulmonary embolism in patients on behavioral health units. This most often occurs in patients with severe behavioral health problems that leave them bedridden. We’ve seen DVT in one patient who had laid in bed at home several weeks prior to admission. Therefore, it is essential that every patient admitted to behavioral health units received an assessment for DVT risk factors just as if they had been admitted to a med/surg unit.
But, just as your risk of falling may change during a hospital stay, your risk for DVT may also change due to events that happen during a hospital stay. One of those events on a behavioral health unit is the use of restraints. A recent study (Funayama 2020) found that use of physical restraints was associated with a 6-fold higher risk of DVT. The researchers analyzed medical records of over 1300 psychiatric inpatients and compared a physical restraint group (those who had been subjected to physical restraint while hospitalized) to a non-physical restraint group. The physical restraint group had a higher risk for deep vein thrombosis (OR = 6.0). Even after controlling for potentially confounding factors, physical restraints substantially raised the risk of deep vein thrombosis. The physical restraint group had a higher risk for aspiration pneumonia (OR = 4.1) when compared with the non-physical restraint group.
Immobility, of course, is probably the most important risk factor for DVT and venous thromboembolism. And, patients on behavioral health units are not immune from the comorbidities that may predispose to DVT in the general population.
But there are other risk factors for DVT that occur in the behavioral health population. A recent study from Taiwan (Lin 2019) found that patients with depressive, bipolar, and schizophrenic disorders had a roughly 3-fold higher risk of DVT and 2.5-fold higher risk of pulmonary embolism than the general population. One possible contributing factor may be the use of certain medications. In our October 2010 What's New in the Patient Safety World column “Antipsychotic Drugs and Venous Thrombembolism” we noted a large population-based case-control study (Parker 2010) showed a 32% increased risk for VTE in patients prescribed antipsychotic medications within the past 24 months. The risk was almost double in patients newly prescribed antipsychotics (within the past 3 months) and was higher for atypical antipsychotics and for low rather than high potency drugs. The overall absolute risk, however, was low. The estimated number of excess cases per 10,000 patients was 4 for all ages and 10 for patients aged 65 or older.
Therefore, it is essential that every patient admitted to behavioral health units receive an assessment for DVT risk factors just as if they had been admitted to a med/surg unit. And that risk assessment should be updated when certain events occur during a hospitalization. Perhaps your restraint protocol should include an item reminding you to update that DVT risk assessment. We’re not advocating that you put such patients on pharmacoprophylaxis. Administration of injections of prophylactic agents might even be detrimental to a patient with a mental state that merits restraint use. But that DVT risk assessment should remind you to be on the lookout for signs or symptoms of DVT or pulmonary embolism. It also emphasizes the need for frequent release of restraints, and perhaps active or passive range-of-motion exercises of the limbs. And, of course, any decision about possible use of DVT prophylaxis should also take into account any other medical conditions that might increase the risk of DVT.
Some of our past columns on DVT risk in behavioral health settings:
Some of our past columns on issues related to behavioral health:
References:
Funayama M, Takata T. Psychiatric inpatients subjected to physical restraint have a higher risk of deep vein thrombosis and aspiration pneumonia. General Hospital Psychiatry 2020; 62: 1-5
https://www.sciencedirect.com/science/article/pii/S0163834319303378
Parker C, Coupland C, Hippisley-Cox J. Antipsychotic drugs and risk of venous thromboembolism: nested case-control study. BMJ 2010; 341:c4245
https://www.bmj.com/content/bmj/341/bmj.c4245.full.pdf
Lin C-E, Chung C-H, Chengh L-F, Chen W-C. Increased risk for venous thromboembolism among patients with concurrent depressive, bipolar, and schizophrenic disorders. General Hospital Psychiatry 2019; 61: 34-40
https://www.sciencedirect.com/science/article/abs/pii/S0163834319303627
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No organization or individual wants to be accused of age discrimination. Yet, we have an obligation to our patients to police ourselves and ensure the competency of our clinicians to provide safe and effective care. The reality is that the incidence of both dementia and mild cognitive impairment (MCI) increase substantially after the age of 65. Prevalence rates for mild cognitive impairment and dementia in those ≥65 years old in the general population have been estimated to be up to 20% and 13%, respectively. While we know of no study that looked at such rates in the physician population, there is no reason to suspect that the rates in physicians differ from that of the general population. And the physician population over the age of 65 continues to increase.
In 2 of our previous columns we discussed some approaches to the issue of how to deal with the issue of credentialing and privileging of older physicians (see our Patient Safety Tips of the Week for July 7, 2015 “Medical Staff Risk Issues” and May 28, 2019 “The Older Physician”).
Recently, Yale New Haven Hospital developed a very practical process for dealing with this issue (Cooney 2020). In their process, physicians age 70 and older undergo a screening cognitive test developed by a neuropsychologist. The Cooney paper does not publish the actual test, noting that the test questions remain confidential so that prospective test takers cannot practice for it. But the article describes the general content of the test.
The screening battery used consisted of 16 brief tests including rudimentary information processing (2 tests), visual scanning and psychomotor efficiency (2 tests), processing speed and accuracy under decision load (1 test), concentration and working memory (1 test), visual analysis and reasoning (2 tests), verbal fluency (2 tests), memory (1 visual test and 1 verbal test), “prefrontal” self-regulation (1 test), and executive functioning (3 tests).
A Medical Staff Review Committee (MSRC) consisting of the previous and current chief medical officers of the hospital, a faculty geriatrician, and the neuropsychologist performing the examinations, review the results of this testing and make recommendations to the medical staff’s credentialing committee. Where concerns were raised, the committee reviews the case with the section chief or departmental chair. This review outlines the scope of the clinician’s practice and any concerns that his or her supervisor had about the candidate’s capabilities.
Practitioners with global scores considered within normal limits are allowed to proceed with the regular medical credentialing process. Those individuals are to be rescreened at subsequent recredentialing at 2-year intervals. Practitioners with somewhat lower global scores or who demonstrated relative weakness but not deficits in 1 or 2 abilities proceed with the credentialing process but are scheduled for rescreening in 1 year. Practitioners whose profiles indicate some weaknesses with possible implications for unsafe practices are requested to undergo a comprehensive neuropsychological examination, which involves an in-depth assessment of intellectual, memory, and executive function.
If, at the end of the review, the committee decides that an individual did not have adequate cognitive abilities to practice medicine, the chief medical officer, often with the assistance of another committee member, meets with the clinician to discuss options, including working in a highly structured proctored clinical environment or retirement from clinical practice. These individuals are offered assistance in evaluating medical conditions that may have contributed to their poor examination performance.
The Cooney paper described the results of the new process on a total of 141 clinicians aged 70 years or older. 88.7% were physicians, and the remainder included advanced practice registered nurses, dentists, psychologists, podiatrists, physician associates, and a midwife. 57.4% completed the screening test requirements and proceeded with the regular credentialing process. They were to be retested at 2 years at the time of the regular reappointment cycle. 24.1% proceeded with the credentialing process but were scheduled for rescreening in 1 year because of minor abnormalities on the screening test results. 5% had limitations in domains such as memory, executive function, processing speed, or constructional skills that could impair their capacity to practice medicine. These clinicians were asked to undergo a comprehensive assessment. At the completion of this assessment, 4 of the individuals were determined to be capable of continuing with the recredentialing process. Three clinicians were determined to have significant problems and either retired or resigned from the active medical staff.
Nineteen clinicians (13.4%) were identified as performing substantially less well than their colleagues on the global score of the screening neuropsychological assessment. Twelve of these had such substantial problems on their screening tests that discussions were undertaken with these clinicians to determine how to address these problems. Following those discussions, these clinicians either entered a proctored setting for their practice or retired from medical practice. The other 7 of these 19 clinicians were asked to undergo a full neuropsychological evaluation. At the conclusion of these tests, 4 individuals were allowed to proceed with the recredentialing process and 3 individuals were asked to limit their practice or retire.
After completion of screening and/or full neuropsychological testing, the MSRC determined that 18 clinicians (12.7%) demonstrated cognitive deficits that were likely to impair their ability to practice medicine independently. Of interest, none of these 18 clinicians had previously been brought to the attention of medical staff leadership because of performance problems. These 18 clinicians elected to discontinue their practice or moved into a closely proctored environment. All of these practitioners agreed to make changes in their practice voluntarily.
Two editorials accompanying the Cooney paper (Saver 2020, Armstrong 2020) describe programs utilized at some other organizations and discuss the many challenges in addressing the problem.
Of particular concern, but not surprising to us, was the fact that none of the 18 clinicians in the Yale New Haven experience who had cognitive deficits likely to impair their ability to practice independently had previously been brought to the attention of medical staff leadership because of performance problems. In our two previous columns dealing with the aging physician we described some of the barriers to raising concerns. The physician is often a very well liked and respected physician who has practiced at the hospital and community for many years. But he/she may not be aware of any decline and everyone is afraid to confront him/her about it. Most of his/her patients still love him/her and the board members are his/her friends or have long interacted with him/her in community activities. You may hear whispers amongst staff about their concerns regarding this physician. They all know that sooner or later he/she is going to do something that might result in patient harm. But they are not willing to come forward with specific examples. Medical directors and medical executive committees are often handcuffed when no one is willing to formally come forward with negative information on such physicians. Having a formal process, such as the Yale New Haven one, is one way to bring problems forward without appearing discriminatory toward any one clinician.
We think the process developed at Yale New Haven is both practical and considerate of the individual’s status. It adds an element of objectivity to processes that have often been purely subjective in the past. It can serve as a model to replicate in your organizations.
Our prior columns dealing with the issue of the aging physician:
References:
Cooney L, Balcezak T. Cognitive Testing of Older Clinicians Prior to Recredentialing. JAMA 2020; 323(2): 179-180
https://jamanetwork.com/journals/jama/article-abstract/2758602
Armstrong KA, Reynolds EE. Opportunities and Challenges in Valuing and Evaluating Aging Physicians. JAMA 2020; 323(2): 125-126
https://jamanetwork.com/journals/jama/article-abstract/2758580
Saver JL. Best Practices in Assessing Aging Physicians for Professional Competency. JAMA 2020; 323(2): 127-129
https://jamanetwork.com/journals/jama/article-abstract/2758581
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