Curr Diab Rep (2015) 15:112 DOI 10.1007/s11892-015-0688-0
HEALTH CARE DELIVERY SYSTEMS AND IMPLEMENTATION IN DIABETES (EB MORTON-EGGLESTON, SECTION EDITOR)
Shared Decision-Making in Diabetes Care Shrikant Tamhane 1 & Rene Rodriguez-Gutierrez 1 & Ian Hargraves 1 & Victor M. Montori 1
# Springer Science+Business Media New York 2015
Abstract Shared decision-making (SDM) is a collaborative process by which patients and clinicians work together in a deliberative dialogue. The purpose of this dialogue is to identify reasonable management options that best fit and addresses the unique situation of the patient. SDM supports the patientcentered translation of research into practice. SDM also helps implement a core principle of evidence-based medicine: evidence is necessary but never sufficient to make a clinical decision, as consideration of patient values and context is also required. SDM conversations build on a partnership between the patient and the clinician, draw on the body of evidence with regard to the different treatment options, and consider options in light of the values, preferences, and context of the patient. SDM is appropriate for diabetes care because diabetes care often requires consideration of management options that differ in ways that matter to patients, such as the way in which they place significant demands on patient’s life and living. In the last decade, SDM has proven feasible and useful for
This article is part of the Topical Collection on Health Care Delivery Systems and Implementation in Diabetes * Victor M. Montori
[email protected] Shrikant Tamhane
[email protected] Rene Rodriguez-Gutierrez
[email protected] Ian Hargraves
[email protected] 1
Knowledge and Evaluation Research Unit, Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Department of Medicine, Mayo Clinic, 200 1st Street SW, Rochester, MN 55905, USA
sharing evidence with patients and for involving patients in making decisions with their clinicians. Health care and clinical policies advocate SDM, but these policies have yet to impact diabetes care. In this paper, we describe what SDM is, its known impact on diabetes care, and needed work to implement this patient-centered approach in the care of the millions of patients with diabetes. Keywords Shared decision-making . Diabetes . Evidence-based medicine . Decision aids
Introduction Mrs. Smith is a 50-year-old woman who has been diagnosed with type 2 diabetes for the past 5 years. Her comorbidities include obesity, hypertension, and dyslipidemia. She works in an advertising firm as a sales manager and takes metformin (1 g twice a day). Her body mass index is 32, and she exercises for 30 min five times a week and has been closely watching her calorie and carbohydrate intake. In spite of this, her hemoglobin A1c (HbA1c) has ranged from 7.6 to 8.2 % over the past 6 months. She is worried that her diabetes control is deteriorating and is concerned that she has not been able to achieve the HbA1c goal of 6.5 to 7.0 % her primary care physician specified. She is also worried about the risk of developing diabetes-related complications and wants to know if adding another medication to metformin is necessary and if so, which of the available treatment options would be better. What is the best course of action in this clinical scenario, not for any patient with type 2 diabetes, but, particularly for Mrs. Smith and her family? In almost all clinical situations, there are several, medically sensible, management options available to address their situation. It will often be unclear which of these options will be
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best for the patient, in part because what is best depends on the situation and the patient. Even in situations in which trustworthy evidence compellingly shows that a treatment option is clearly more effective than another in terms of a desired medical outcome, it is possible that an inferior option may be better for a particular patient. This may be because of that option’s effect on other outcomes of importance to the patient, including harms and costs, or because of its effect on that patient’s ability to work, support their family, serve their community, or fulfill other obligations and expectations [1••, 2, 3•, 4]. In the case of type 2 diabetes, even though several medications have the potential to reduce HbA1c, the available evidence has not shown them to be different in their impact on preventing the diabetes-related complications. However, they differ significantly in terms of their frequency and route of administration, risk of hypoglycemia and weight gain, need for glucose self-monitoring, and cost [5–8]. These differences impact the daily lives of patients. It is attention to these differences that should orient the selection of the best antihyperglycemic agent for Mrs. Smith at this time. Of note, patient preferences for a particular treatment do not exist in abstract, but form as a result of confronting the options and how each is able to address the patient situation. Thus, this process cannot take place without access to trustworthy evidence (without which the patient will be misled) or patient participation (without which the preferences used to select an option are not the right ones) or out of context (that may affect the situation and therefore the preferences formed). Therefore, the selection of the best management strategy for this patient in this situation must take place with the patient as the situation arises.
What Is Shared Decision-Making? The question that patients burdened with illness, such as diabetes, bring to their clinicians is simply what is best for me and my family? While the question is simple, answering it is not. The development of medicine over its long history can be thought of as an endeavor to find better responses to the question, what is best? A major step forward took place early in the 1990s with the formulation of evidence-based medicine (EBM) [9–13]. EBM recognized two fundamental principles: (a) research evidence with different levels of protections against error warrant different levels of confidence in the estimates they produce, a principle sometimes described as the hierarchy of evidence and (b) evidence alone is never sufficient to make a fully informed decision—treatment decisions should also take into account the values, preferences, and circumstances of the patient. As discussed by Hoffmann and colleagues, SDM is necessary for EBM to translate its two principles into patient-
centered care, a form of care that is respectful of and responsive to individual patient preferences, needs, and values. Without patient participation in SDM and the opportunity to consider patients’ values and preferences, EBM risks devolving into Bevidence tyranny,^ in which care is driven exclusively by data without sufficient and necessary individualization or contextualization [14•]. On the other hand, without considered attention to the research evidence, decisions will not reflect what is best if patient preferences are formed based on unreliable information. Consequently, EBM and SDM complement each other and SDM is a critical strategy to translate evidence into everyday clinical practice. Implementing the second principle of EBM requires bringing the patient perspective to bear on the decision-making process. In shared decision-making (SDM) both patients and clinicians are experts. While the clinician is an expert in the evidence and medical aspects of the disease, patients are experts on how they experience and live with the illness, what they value most in their lives, and how a certain course of action fits and might be implemented in their particular circumstance. SDM brings these two experts, patients and clinicians, together to deliberate [15–17]. This process of collaborative deliberation involves appreciation by both parties of the threat posed by illness that demands a decision, the different and sensible ways available in which the situation can be addressed, and how those approaches may have a different impact on the patient’s particular circumstance. For preferences to emerge that are responsive to the threats of illness and the possibilities of treatment, patients, and clinicians have to consider treatment options in a manner that explores their impact on the patient’s context. This is an interactional activity in which access to evidence about the comparative effectiveness of the management strategies (harms and benefits) is necessary, but not sufficient. SDM requires a bidirectional exchange and partnership between the health professional and the patient in order to demonstrate and agree that a course of action is best for this patient at this time (Fig. 1). In general, theorists have proposed that the SDM process involves the following: & &
&
Creating a conversation starting from a partnership formed to deal with the situation by means of identifying the best course of action. Exchanging information, a bidirectional process in which research evidence, patient and clinician experiences, expectations, concerns, fears, and values are shared. The ultimate goal of this step is to use this exchange to acknowledge what matters most to the patient. Deliberating collaboratively, a process seamlessly integrated with the prior step, by which patients and clinicians consider how the issues that matter most to the patient are impacted by the available options as they become
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Fig. 1 Shared decision-making model
&
implemented in the patient’s life. This process is akin to testing hypotheses in thought experiments. Coming, by mutual agreement, to a decision that reflects the evidence-informed patient preferences and has a good likelihood of addressing the situation [16].
The reality of SDM is probably simpler. Perhaps it is best thought as a natural conversation to address the situation of the patient, in which the patient is respected and helped to become involved. In this conversation, evidence is brought to bear to help address the patient situation. The best course of action for this patient’s situation emerges in conversation organically, from the work patients and clinicians do together.
Diabetes Care and SDM—a Perfect Match? Diabetes is a chronic illness that is a major public health concern affecting over 300 million people worldwide [18–20]. Diabetes prevention and treatment have gained priority due to the large direct and indirect costs and substantial suffering and loss of life associated with diabetes and its complications [21–23]. Diabetes is also a significant burden to the patient and to their families, with much of this burden due to the demands of treatment. For individuals and families living with diabetes, the disease represents much more than a simple HbA1c ≥6.5 % at diagnosis and a HbA1c treatment target of ≤7.0 %. Given the importance of type 2 diabetes, one would assume the availability of high-quality evidence supporting most of the current treatment recommendations. This is not the case. For diabetes, over 40 % of the recommendations of the Endocrine Society guidelines (including aspects related to diabetes, obesity, and cardiovascular disease) are based on low-quality evidence and close to 20 % of the recommendations are based
on very low-quality evidence [24]. This places heavy demands on clinicians committed to the evidence-based management of diabetes. For instance, antihyperglycemic medications have not been proved to be different in terms of their potential to prevent micro- and macrovascular diabetes complications. They differ, however, in terms of safety (e.g., hypoglycemia) and treatment burden profiles (e.g., injectable vs. oral, cost, dosing frequency, and need for glucose self-monitoring) [7, 8, 25–29]. In addition, even well-accepted recommendations such as the use of metformin as first-line therapy, are based on very limited evidence. Metformin’s convenience, inexpensive cost, and safety profile with minimum risk of hypoglycemia, weight gain, and other serious adverse effects, which makes it a common compelling monotherapy option for both patients and clinicians [29–31]. Given the state of the evidence and the differential impact of these agents on people’s lives, the choice of antihyperglycemic medication is not straightforward. It is highly appropriate for clinicians to share decision-making with their patients to find the best antihyperglycemic agent for this patient in this situation. Beyond the limitations of evidence, individualizing treatment through SDM is necessary in diabetes care because 50– 80 % of patients are accompanied by what has been called the most common chronic condition worldwide, multimorbidity [32, 33]. A patient that already has to live with the burden of diabetes and its treatment may also have to live with, treat, and manage multiple other chronic conditions such as obesity, dyslipidemia, cardiovascular disease, chronic kidney disease, hypertension, osteoarthritis, and depression, among others. Even when evidence offers high confidence in the benefit of a treatment, the context of the patient with multimorbidity has to be taken into account. Any treatment option represents not only a set of potential benefits or harms as a result of its direct action but also as a result of its interaction with the other conditions and their treatments. Also, each treatment option
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incurs an obligatory set of activities that will require the patient’s energy and time. New treatments may increase the workload of a patient that might very well be already overwhelmed by comorbidities and their complex treatment regimens [34]. SDM in this scenario offers the possibility to make treatment decisions that better fit and are more likely to safely and effectively address the needs of the patient in their specific context.
Decision Aids and the Evidence Behind SDM Tools have been developed to support shared decision-making. Most function as patient education materials—providing the patient alone with information to make decisions. More recently, SDM has moved beyond sharing information with patients to forming environments in which clinicians and patients share in addressing the challenges of illness. Tools such as encounter decision aids (DAs) have been designed specifically to lightly support patients and clinicians in deliberation during the clinical encounter [35, 36]. Our perspective is that such in-visit DAs are particularly supportive of decisional conversations in which the principles of SDM can be put into practice. To ensure that patient preferences are formed from accurate trustworthy evidence, high-quality DAs must be designed based on a comprehensive and up-to-date summary of critically appraised evidence [37]. Additionally, DAs should be designed to be used and implemented by clinicians with minimal training in SDM and at the same time be easy to understand and use with patients at various levels of literacy. A recent Cochrane Collaboration systematic review of 115 RCTs of patient DAs—most of which were used by patients alone—found that when compared to usual care, DAs increased patients knowledge, helped patients choose an option that was congruent with their values, lowered their perceived decisional conflict, reduced the proportion of patients that reported being passive in the decision-making process, decreased the number of patients that remained undecided, and had a positive effect on patient-clinician communication as perceived by both parties. Use of these DAs increased the consultation time by about 3 min on average and had no consistent effect on treatment choices, adherence to therapy, health-care use, or costs [38].
Promoting Shared Decision-Making in Diabetes Care—Our Experience After a comprehensive literature review, we found five randomized trials that have tested DAs in diabetes care (Table 1) [39–43]. Of the five trials, four were from our research group. And of these, specifically in diabetes care, our group has
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developed and trialed two DAs (Statin Choice DA and the Diabetes Medication Choice DA) (Table 1) [44, 45]. The Statin Choice DA, is intended to aid patients and their clinicians have meaningful conversations about whether to use statins in primary cardiovascular prevention. It presents the patient’s 10year cardiovascular risk in a pictogram, along with the risk reduction associated with statin use. The tool also opens the decision conversation to consideration of issues (cost, daily routine, side effects, and cost) that using statins will carry [45]. The Diabetes Medication Choice DA helps patients and clinicians consider the benefits (HbA1c reduction), harms (hypoglycemia, weigh gain, other side effects), convenience (daily routine, daily glucose self-monitoring), and cost of each of the diabetes medications when a decision about starting a diabetes medication has to be made (Fig. 2) [44]. Overall, the trials have demonstrated lessening of decisional conflict; increase in patients’ knowledge, communication, and involvement in the decision-making process; promotion of realistic expectations and autonomy; and, in the case of the Statin Choice tool, better patient estimate of their 10-year cardiovascular risk and potential absolute risk reduction with statins. In addition, time in consultation was not significantly longer (3 min) compared to usual care, despite the requirement to use the DA during the consultation. Adherence, HbA1c, and reduction in the incidence of diabetes complications did not change with one-time use of the DA. In general, adherence to medications in the trial population in both intervention and control groups was high and they evidenced good glycemic control. Larger-scale RCTs with longer follow-up may help answer questions of adherence—particularly in patients exhibiting nonadherence at baseline due to cognitive participation issues (rather than to practical issues of planning and executing routine medication use) and poorer initial glycemic control working over time with clinicians able to engage patients in care. These results are promising and exciting, but more work is needed. Only two common situations in diabetes care have been studied, diabetes medication choice and stain use for the primary prevention of cardiovascular disease. A long list of situations in diabetes care in which patients face several reasonable options and that may benefit from SDM including treatments (e.g., use and timing of bariatric surgery or weight loss medications), evaluations (e.g., manner and frequency of detection of asymptomatic retinopathy), and goals (blood pressure and HbA1c goal selection) [46–51]. If we revisit the case with which we began and imagine we are observing the encounter of Mrs. Smith and her clinician using Diabetes Medication Choice, the first thing that would be noted is that Mrs. Smith and her clinician are turned together in a side-by-side conversation. The dialogue begins with both parties recognizing that a new medication has to be started in order to achieve better glycemic control and that there are several reasonable treatment alternatives or options
Adult Urban minority To take or not take statins patients primary care For primary CV prevention with practice type 2 diabetes Adult 49 genera Treatment choices about their patients medical type 2 diabetes treatment with practices including whether or not to type 2 start insulin diabetes
Mann et al. 2010, USA DA=95 C=80
Usual care + educational pamphlet
Usual care + pamphlet about cholesterol management
Usual care
Diabetes Medication DA Usual care and Statin Choice Decision Aid
Brief training of clinicians and use of PDA with patients in single consultation
To participate in a usual Usual care + primary care visit with pamphlet the Statin Choice tool
Diabetes Medication Choice DA cards
Statin Choice DA cards
Comparator
DA decision aid, C control, CV cardiovascular, DAD decision aids for diabetes
All DAs were tested during the clinical encounter. Matherns et al.’s DA was used both during and outside the clinical encounter
Branda Adult 10 nonConsider changing their DA=53 et al. patients academic and diabetes medication or lipid- C=50 2013, with rural primary lowering regimens USA type 2 care practices DAD trial diabetes
Matherns et al. 2012, UK
DA=48 C=37
Adult 11 primary care Decision about starting a patients and family diabetes medication with medicine type 2 sites diabetes
Mullen et al. 2009, USA
DA=80 C=70
DA=52 C=46
Weymiller Adult Speciality clinic To take or not take statins et al. patients For primary CV prevention 2007, with USA type 2 diabetes
No. Intervention participants included
Population Setting
Author, year, country
Decision to be made
Randomized clinical trials that have tested decision aids in diabetes care
Table 1
Improved knowledge (diff. 2.4 on scale of 9; CI 2.2–19.7) Better estimation of CV risk (OR 22.4, CI 5.9–85.6) and potential to understand their absolute risk reduction with statin drugs (OR 6.7, CI 2.2–19.7) Less decisional conflict when compared to the control group (diff. −10.6 on scale of 100; CI −15.4 to −5.9) Improved knowledge (AMD 1.10, CI 0.11–2.09) More involvement in making decisions about diabetes medications (AMD 21.8, CI 13.0–30.5) At 6-month follow-up, both groups had a nearly perfect medication use and no significant impact on HbA1c levels (AMD 0.01, 95 % CI −0.49 to 0.50) More likely to accurately perceive their underlying risk for a heart attack without taking a statin (OR 1.9, CI 1.0–3.8) and with taking a statin (OR 1.4, CI 0.7–2.8) A decline in CV risk overestimation There was no difference in statin adherence at 3 or 6 months Lower total decisional conflict scores (17.4 vs 25.2, p
