key: cord-1049558-3eovj63c
authors: Abrams, Elissa M.; Shaker, Marcus; Oppenheimer, John; Davis, Ray S.; Bukstein, Don A.; Greenhawt, Matthew
title: The Challenges and Opportunities for Shared Decision Making Highlighted by COVID-19
date: 2020-07-14
journal: J Allergy Clin Immunol Pract
DOI: 10.1016/j.jaip.2020.07.003
sha: d0e5364fabba76d418cd36decad9ea90c3ffb9ee
doc_id: 1049558
cord_uid: 3eovj63c

Abstract Shared decision making (SDM) is a management paradigm that empowers patients as partners in their own care in a bidirectional exchange of information and values, and optimize the decision-making process. During the current COVID-19 pandemic, there is a greater need to encourage participation in the SDM process. The pandemic has created both challenges and opportunities for delivering care, as system adaptations influence the physician-patient relationship. While social distancing and health service reallocation can interfere with preference for an in-person visit, these measures also provide an avenue to study and implement virtual SDM processes. Communicating risk at a time of heightened uncertainty may pose a barrier to SDM engagement but provides the opportunity to foster a patient-centered approach within a more personalized context. Social media influence during COVID-19 has resulted in an ‘infodemic’ but highlights the importance of patient engagement. The pandemic has changed how we deliver care but allows us to re-evaluate common practices and enhance effectiveness of our management strategies. Navigating the uncertainty of subsequent pandemic waves creates confusion about how to safely reinitiate clinical service. This will require ongoing SDM with our patients and amongst colleagues through current—and future—challenges. COVID-19 has created many difficulties but has forced us to re-examine how to provide more patient-centered and high-quality care.

Allergy and Clinical Immunology In Practice, the Journal of Food Allergy and the Annals of 44 Allergy, Asthma, and Immunology. 45 46 John Oppenheimer has received financial support from DBV, TEVA, GlaxoSmithKline 47 adjudication/data safety monitoring board, AstraZeneca, Novartis, and Sanofi; is Associate 48

Editor of the Annals of Allergy, Asthma, and Immunology and AllergyWatch, an American 49

Board of Internal Medicine (ABIM) Council Member and American Board of Allergy and 50

Immunology Liaison to the ABIM * , UpToDate Reviewer, ACCP Cough Guideline Committee 51

Member, and WebMD Editor. 52 53

Ray Davis is a consultant for Shire, Baxalta, Circassia, Takeda, Genentech, Novartis, ALK, 54 AAOA, Eastern Pulmonary Conference 2019, DBV Technologies, Maculogix, and speaker for 55 DBV Technologies, Novartis, ALK and is the co-owner of The PBL Institute, LLC, and teaches 56 problem-based learning techniques for many companies & CME conferences. 57 58 59

Don Bukstein is a consultant for the American Academy of Otolaryngic Allergy; has a CME 60 grant; is a speaker for Odactra from ALK, AstraZeneca, Niox from Circassia, Teva 61

Pharmaceutical Industries, Novartis, and Genentech; is a consultant for Cuvitru and HyQvia 62 from Baxalta, and for Cuvitru, HyQvia, Xiidra, and Vyvanse from Shire; is the co-owner of 63

The PBL Institute, LLC, and teaches problem-based learning techniques for many companies 64 & CME conferences. 65 66 Matthew Greenhawt is supported by grant #5K08HS024599-02 from the Agency for 67

Healthcare Research and Quality; is an expert panel and coordinating committee member 68 of the NIAID-sponsored Guidelines for Peanut Allergy Prevention; has served as a consultant 69

for the Canadian Transportation Agency, Thermo Fisher, Intrommune, and Aimmune 70

Therapeutics; is a member of physician/medical advisory boards for Aimmune Therapeutics, 71 DBV Technologies, Sanofi/Genzyme, Genentech, Nutricia, Kaleo Pharmaceutical, Nestle, 72

Acquestive, Allergy Therapeutics, Allergenis, Aravax, and Monsanto; is a member of the 73 scientific advisory council for the National Peanut Board; has received honorarium for 74 lectures from Thermo Fisher, Aimmune Therapeutics, DBV Technologies, Before Brands, 75 multiple state allergy societies, the American College of Allergy Asthma and Immunology, 76

the European Academy of Allergy and Clinical Immunology; is an associate editor for the 77 Annals of Allergy, Asthma, and Immunology; and is a member of the Joint Taskforce on  78  Allergy Practice Parameters  79  80  81  incorporating best available evidence and patient preference. 1 SDM integrates all available  104 evidence-based screening, treatment, or management options and provides the 105 opportunity to explore potential benefits, trade-offs, and risks of each approach before a 106 decision is made, promoting patient engagement in decisions regarding their healthcare. 1 107 SDM has been touted as a national priority for comparative effectiveness research by the 108 Institute of Medicine due to the ability to emphasize 'patient choice for preference-109 sensitive care' 2 and has been adopted as a research priority by PCORI (Patient-Centered 110

Outcomes Research Institute). 3 The Salzburg statement on shared decision making notes an 111 ethical imperative on the part of clinicians to 'stimulate a two-way flow of information' and 112

to 'tailor information to individual patient needs and allow them sufficient time to consider 113 their options.' 4 The use of SDM speaks to the larger context that evidence doesn't make 114 decisions, people do. 5 115 SDM has been incorporated into national policy in multiple countries. 1,6-8 In the US, 116 five states have incorporated SDM laws, with some linking an SDM requirement to 117 formation of any Accountable Care Organizations. One such example is the Washington 118 State law, which provides a higher level of protection in informed consent liability claims 119 when SDM was used in keeping with state requirements. 9 SDM has been shown to improve 120 decision quality, 10 decision making processes, 10 patient adherence, 11 risk perception, 1,11 and 121 patient outcomes, 12 while lowering healthcare costs, 12 health care resource utilization 12 122 and enhancing patient autonomy with respect to decision-making. 12,13 Within allergy and 123 immunology, studies regarding the use of SDM have been predominantly within the field of asthma, which showed improved medication adherence, 14 asthma clinical outcomes, 14 We face unprecedented times in healthcare with the novel coronavirus pandemic 138 COVID-19, caused by the pathogen SARS-CoV-2, which has affected over 11.5 million people 139 internationally with over 539,000 deaths as July 6, 2020. 24 The highest caseload is in the 140 United States, with over 2.9 million cases of COVID-19, which threatens to exceed 141 healthcare capacity in certain areas over the next year. 24,25 COVID-19 has forced a 142 reconceptualization of how to provide quality health care while enforcing public health 143 measures necessary for pandemic containment and optimal allocation of healthcare 144 resources. 26 With tough decisions, there is an even greater imperative to engage patients 145 regarding care options, creating a unique role for SDM. This unparalleled time presents some barriers to traditional SDM engagement given 147 reduced face-to-face contact, but also an opportunity to evolve incorporation of SDM into 148 our practices both during, and in the post-pandemic landscape. Herein, this paper will 149 discuss the challenges that COVID-19 poses for SDM, in terms of health service reallocation, 150 communicating uncertainty, social media influence, re-evaluation of many of the current 151 assumptions that guide the practice of allergy/immunology, and navigating the uncertainty 152 of future pandemic waves. can evolve in a pandemic in some practices, though data are needed to ensure safety is not 176 sacrificed. Evidence also suggests for highly health-literate patients, home allergen 177 immunotherapy can be a cost-effective alternative to clinic immunotherapy during the 178 pandemic in some circumstances. 28 179 Enforced social distancing also provides a unique opportunity to study and implement 180 'virtual' shared decision making (VSDM). It is unknown how significantly virtual visits impact 181 the physician-patient relationship and the ability to engage in the SDM process, nor its 182 utility in those with low health literacy or those who are less technologically adept. VSDM 183 has not been studied in allergy/immunology, but other specialties have demonstrated 184 improvement in clinical outcomes with a VSDM telemedicine approach. 29 A sub-analysis of a 185 stratified randomized controlled trial (N=60,185) showed that a telephonic SDM approach 186 (incorporating telephonic coaching with decision aids that could be mailed, emailed or 187 delivered online) resulted in lower medical cost, hospital admission rate, and fewer 188 preference-sensitive interventions compared to the usual care group in patients with a 189 variety of chronic health conditions such as diabetes, asthma, and chronic obstructive 190 pulmonary disease. 12 This suggested 'a remote model, combining telephonic coaching with 191 decision aids, should be considered as either an add-on to provider-based interventions or a 192 stand-alone option.' While SDM models often incorporate a team-based approach, 30-33 193 which is more difficult to implement and coordinate during a pandemic, telephonic SDM 194 provides the potential to maintain a team-based SDM despite such circumstances. facilitators of pediatric SDM noted that for adopters, in particular parents, lack of research 218 for diagnostic and/or therapeutic options is a barrier to engaging in SDM, and that higher 219 stake decisions reduced willingness to participate in SDM. 40 While SDM in the context of a 220 pandemic has not been studied, higher degrees of uncertainty and perceived higher stakes 221 with particular decisions may be a distinct barrier to the SDM process until more accurate 222 data are available regarding the relative risks/benefits of options within the broader context 223 of allergy/immunology services and COVID-19. 224

Opportunities: One patient-centered step that could be taken, which incorporates 225 medical uncertainty, is to include goal setting and dispositional hope as a component of any 

Challenges: The pandemic has unequivocally forced change in how we deliver 257 allergy/immunology care as a by-product of limited resources and heightened infection risk. 258

However, there is a tendency for "paralysis by analysis", in necessitating evidence from 259 randomized controlled trials that are unlikely to be funded/performed. There are many 260 decisions that are made -such as intradermal testing for delayed amoxicillin exanthems, 261 pre-emptive screening prior to food introduction, and administering maintenance 262 immunotherapy in the office in select circumstances-that have been shown to be largely 263 unnecessary from a safety standpoint, not cost-effective, and even potentially harmful in 264 some situations. 50-54 265

Opportunities: This unprecedented time allows us to reopen the conversation that 266 'evidence is derived from groups, whereas medicine is applied to individuals.' 39 Every 267 specialty has practices that require an evolutionary nudge to enhance effectiveness. March/April 2020, most states issued stay at home orders and halted non-essential 295 ambulatory care services. As regional first waves of the pandemic subside, many 296 ambulatory care services deemed elective or less essential at the start of the pandemic may 297 begin to resume. 58 It is highly unlikely that treatment, vaccination, or cessation of SARS-298 CoV-2 transmission will occur in the coming months to allow normal medical practices to 299 resume without needing PPE, and some measure of physical distancing. Adding to this 300 uncertainty is if second/third pandemic waves will cause resumption of strict physical 301 distancing, stay at home orders, and repeated start/stop cycles of many aspects of society, 302 including ambulatory care. Already, in response to a subjective determination of what 303 constitutes 'essential care' some practices have forged ahead, whereas others have scaled 304 back. Patient demand may be dependent on regional density of infection, and personal 305 beliefs regarding the state of allergic/immunologic conditions versus their risk perception of 306 acquiring COVID-19 through routine care. 307

Many of us will face a decision shortly (if not already) how to re-initiate service, and how 308 to prioritize certain patients/diagnoses over others as capacity to provide more routine care 309 emerges-a recently published document in this Journal discusses a phased approach in 310 doing so, which aims to help the clinician consider different choices and trade-offs, 311

including the role of SDM 58 . SDM needs to occur on two levels-within clinicians and then 312 between the clinician and patient. At the clinician level, decisions about the ability to 313 protect staff/ patients and sanitize rooms while maintaining effective spacing, as well 314 decisions reflecting office/practice finance are crucial. Hard decisions will have to be made, 315 based on imperfect information, and some degree of trade-off that we may rather avoid in 316 any other context. A parallel to this untenable decision-making situation can be drawn from 317 the movie Star Trek 2: Wrath of Kahn, and the Kobyashi Maru training exercise, where 318 cadets in leadership must choose between abandoning a disabled ship that has lost 319 communication capacity in Klingon territory (where they will be destroyed) vs. entering into the territory, sparking a war, and risking their own lives as well as the lives of the other ship 321 in a rescue attempt. 59 The point of the exercise is not to "win", but to understand 322 decisional trade-offs that may have to occur. Reflecting on the cultural reality of situations 323 dominated by some degree of loss is informative and reminds us that we are neither alone 324 nor at the end of this journey. Many may have faced, or will face, such untenable decisions 325 to close their office, furlough/fire staff, curtail salary, or to remain open at a significant loss 326 of revenue, and clinicians need to understand their own decisional needs in this context. 327

Opportunities: SDM with our patients in this context, where we contemplate starting to 328 offer more services, has to be handled carefully but provides the opportunity to re-examine 329 what is considered essential in-person care. 58 Infection risk may be low enough to cross a 330 threshold in favor of resumption of allergy/immunology care, though again this is a 331 discussion to have with patients, possibly through telemedicine visits prior to an in-person 332 appointment. For example, face-to-face visits for stable asthma, in someone due for a 333 yearly evaluation, may have a different threshold than someone with asthma that has been 334 less adequately controlled in the last few months. Making these decisions will require 335 knowledge of community transmission risk and emergency services capacity. The 336 opportunity to re-examine how to proceed with routine evaluation for allergic rhinitis and 337 initiating immunotherapy exists, which may be viewed as less acute needs by some, but 338 highly important to others. The clinician must be aware of the risks/ benefits of the 339 condition, deferment of traditional routes and time intervals of evaluations with respect to 340 the condition, the risk of contracting COVID-19, and their own countertransference 341 issues/financial conflicts as well. 342 Table 2 outlines a needs assessment for SDM in the current pandemic that includes 345 defining a SDM process (either in person or virtually), developing a certification process for 346 decision aids and providing incentives for their evaluation and maintenance, promoting 347 competency in SDM, developing pandemic-specific SDM measures, fostering a culture of SDM 348 and using SDM to help with documentation of quality improvement. 349

It could be argued that SDM is more essential than ever to meet the individual needs of 350 our patients during this era of change. In the day-to-day allergy practice, incorporating SDM 351 when evaluating in-person versus virtual visits, and essential versus non-essential care, is of 352 paramount importance. Decision aids are necessary for many aspects of ongoing allergy care. 353 SDM should be incorporated into allergy policy and guidelines, and considered an inherent 354 aspect of medical education. 355

In general, SDM has focused on short-term outcomes such as patient satisfaction, 356 short-term clinical outcomes, or decisional conflict. However, there has been a call to 357 conceptualized SDM within a broader interactional/adaptable and organizational framework. 60 Where SDM occurs is likely far less important than if the process itself occurs. While this has traditionally been achieved with in-office, inperson discussion, use of telehealth tools can extend the definition of the "office" and "inperson". At home with the family may be superior for some, as it may allow for more individuals affected by the decision beyond the patient to participate. Shared decision making takes too much time Incorporating SDM should be viewed as an extension of the normal planning for any treatment decision, where patient input should be sought. Some discussions and decisions may be more involved and may require additional visits or conversations. Involving staff and validated SDM aids may be helpful to facilitate this process and can be distributed to the patient before or after a visit, which could save face-to-face time if this is a concern. Most patients prefer not to participate in medical decision making

There is no evidence that this is factual. The degree to which a patient wants to participate in this process is variable, and may depend on the issue at hand, the treatment decision, the patient, and the perception the clinician is receptive to patient input. Few health care decisions are appropriate for SDM All decisions should have patient input. Where there is a very clear and strongly recommended treatment (e.g. treating asthma vs. leaving it untreated), there may be less efficacy of SDM tools vs. situations where there is less clarity in which option to choose (e.g., which asthma treatment should be chosen) SDM conflicts with guidelines and quality measures SDM has been shown to only enhance not deter clinical outcomes, improve engagement, and would involve choices that are derived from guidelines and quality measures as part of the considerations in the treatment decision Clearly define the SDM process through either in-person or virtual encounters Develop a certification process for decision aids and provide incentives for their evaluation and maintenance.

Promote competency in shared decision making, and a skills assessment so that clinicians can understand their current competency level and needs assessment in SDM Develop pandemic-specific SDM measures

Foster a culture of shared decision making Use SDM to help with documentation of quality improvement 

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