Designing and evaluating an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes in clinical care - systematic decision aid development and study protocol

Prevention of diabetes complications requires a multitude of self-management tasks which are time-consuming. For example, following the American Diabetes Association recommendations for self-management would take 143 minutes per day [1]. Patients spend a mean of 58 minutes per day on self-care, with the largest barrier to additional care being ‘not enough time’ [1]. To compound this, the majority (56%) of people with diabetes have two or more additional chronic conditions [2]. Patient adherence to clinical practice guideline (CPG) recommendations is impacted by multi-morbidity, as it directly impacts self-management ability (e.g., depression) [3] and competes for time and attention [4] (Yu CH: Impact of a web-based self-management intervention for patients with type 2 diabetes on self-efficacy, self-care and diabetes distress, submitted). For example, patients with a greater overall number of comorbidities placed lower priority on diabetes, had worse diabetes self-management ability [5, 6] and poor cardiometabolic control [7]. Patients with a greater number of comorbidities also valued longevity and quality of life (e.g., reduction in complications) [8, 9]. In contrast, primary care physicians prioritized glycemic control, blood pressure control, and lipid lowering over interventions such as retinal and renal screening [10]. In one study where primary care physicians were mailed a clinical vignette of a patient with diabetes whose main issue was worsening chronic low back pain, only 44% of physicians prioritized pain as the primary issue [11]. Thus, competing disease priorities and competing patient-physician priorities present challenges in the provision of care for the complex patient.

To help patients and providers reach goals in managing multiple risk factors, effective shared decision-making (SDM) tools, or decision aids, are needed to facilitate prioritization of treatment options. SDM consists of patients and providers establishing an ongoing partnership in exchanging information; deliberating on options; and deciding upon the priority for taking action and acting on the decision [12]. Though initially developed for use in acute care contexts, it has been adapted for use in chronic care, including diabetes [13]. SDM has the potential to improve patient care. A systematic review of randomized controlled trials of SDM identified 11 studies [14]; interventions included an interactive video program, question/information sheet, or card-ranking discussion. Of the five studies that examined physical and psychological wellbeing, two studies reported positive outcomes; both were characterized by long-term decisions that occurred over more than one session in the setting of chronic disease, thereby indicating a role for SDM in complex diabetes care.

Mediating factors to the successful implementation of SDM have been reported. In a review of 38 studies [15], the most common barriers were time constraints, and lack of applicability due to patient characteristics and his/her clinical situation. Facilitators of SDM included provider motivation, having a positive impact on clinical process and outcome [16], healthcare provider training, and patient-mediated interventions [17]. Specific to diabetes, patients have reported that patient/provider power imbalance, health literacy and denial of the condition were barriers to SDM. Provision of medical knowledge, validation of patient experiences, strong interpersonal skills, and provider availability were facilitators of SDM [18].

These barriers to SDM can be overcome by incorporating IP care providers. Furthermore, diabetes care may occur in the context of interprofessional (IP) care [19], defined as promotion of high-quality care through synergistic efforts of multiple healthcare professionals’ [20‐23]. Several systematic reviews in diabetes care have shown that role expansion, active participation by more than one discipline, and the addition of new healthcare team members [24‐26] improve clinical outcomes. In addition to improving clinical parameters, incorporating an IP approach may facilitate uptake of SDM [27].

SDM can be facilitated by the use of patient decision aids (PtDAs) [17, 28, 29], as they help frame the decision to be made. A 2011 Cochrane review of PtDAs [30] identified 86 studies and found that PtDAs improved decision quality and process, and that detailed PtDAs were more effective than simpler PtDAs [31]. Furthermore, when the PtDA was used within the consultation with the healthcare practitioner, patients were more likely to achieve SDM with their practitioner when compared to patients using a PtDA on their own [31, 32]. In a search of the published literature, we identified four PtDAs focusing on diabetes, one evaluated with a prospective observational study [33], and three evaluated through randomized controlled trials [34‐37]. These PtDAs included a goal-setting intervention [33], ‘Diabetes Medication Choice’ [38], ‘Statin Choice’ [34‐36, 39], and a ‘Metabolic control’ aid [37]. These were studied in specialty clinics [33‐36], primary care [38, 39] and general public [40]. While knowledge, risk perception, satisfaction, decision-making participation, trust, decisional conflict, and documented goals improved, there was no impact on diabetes empowerment nor clinical outcomes; effect on adherence was mixed. With the exception of one tool [33], these PtDAs focused on one specific decision (such as the decision to initiate lipid-lowering therapy) and did not specifically address patient-important priorities and decisions. However, potential exists for their use in setting healthcare goals and prioritizing disease management strategies in patients with diabetes and other comorbidities [33]. Corser et al. (2007) has set the precedent with a brief SDM goal-setting intervention in an American primary care clinic [33]. This intervention consisted of a 28-page patient workbook, a 2-hour patient education session and two 2-hour medical resident seminars. Post-intervention knowledge increased significantly (P = 0.001), as did a number of documented diabetes goals (pre: 0.67 goals; post: 1.09 goals; P <0.001). Glycemic control, weight, and diabetes empowerment scores showed a trend toward improvement. While this study was limited by its observational nature, it suggests a role for SDM in goal-setting in patients with diabetes. We anticipate that effectiveness can be further optimized with the additional provision of a point-of-care tool for use at the time of consultation and a provider-specific tool, to be used longitudinally, and with more explicit integration of the interprofessional team.

We hypothesize that a multi-component PtDA toolkit (patient-directed, provider-directed and point-of-care tools) that individualizes care priorities and incorporates an IP approach to SDM may help to prioritize complex guideline recommendations for patients with type 1 or type 2 diabetes and other comorbidities. Therefore, such a tool may improve the relevant uptake of the Canadian Diabetes Association (CDA) 2013 CPG [41] into practice.

This study will be guided by the Knowledge to Action (KTA) framework [42] to develop, test and refine a multi-component IP-SDM toolkit designed to help prioritize guideline-based disease management in patients with multimorbidity, defined as those with type 1 or type 2 diabetes and additional chronic conditions. In the KTA framework, knowledge is created, refined, then applied through seven iterative steps. This model is appropriate for the systematic development and evaluation of our intervention as it allows for close integration of researchers and knowledge-users, systematic and iterative intervention development, rigorous evaluation and sustainability. In this protocol, we outline the first four steps (Table 1). We also integrated the Medical Research Council framework for the development and evaluation of complex interventions [42], as it provides additional rigour regarding complex interventions, defined as those that entail numerous interacting components, numerous behaviours required, numerous groups targeted, or numerous outcomes [42]. This combined model is appropriate for the systematic development and evaluation of this intervention [43].

Diabetes is a complex disease, often associated with multiple other conditions. Competing disease priorities and competing patient-physician priorities present challenges in the provision of care for the complex patient, thereby reducing guideline adherence. Adopting a patient-centered SDM model of care, wherein the patient sets goals and management priorities with the support of healthcare providers, has the potential to improve uptake of patient-relevant guideline recommendations, improve the process of care and patient-important outcomes such as quality of life. Our objective is to systematically develop, test and refine a diabetes-focused SDM and priority-setting PtDA following the KTA framework [32].

While SDM and the use of PtDAs hold promise, successful implementation would require good quality PtDAs targeting the users’ needs with careful attention to development [48], effective mechanisms and formats to deliver it in clinical care [30], and models to support their implementation in clinical practice [31]. We will address these factors in our project.

Study strengths include our systematic evidence-based and user-centered development and implementation, enabled by team expertise and knowledge-user engagement. The team includes expertise in shared decision-making, knowledge translation, information technology, primary care diabetes, and qualitative and quantitative research methods, as well as key knowledge users – primary care providers and people with diabetes.

Study limitations include potential volunteer bias and recruitment. To address volunteer bias, we will compare socio-demographic characteristics of participants and non-participants. Successful recruitment and implementation will depend on strong knowledge user engagement, which we have developed by creating a combined knowledge user-researcher team.

Competing health concerns present real obstacles to people living with diabetes and other chronic disease and their primary care providers. Guideline implementation interventions to date do not acknowledge these impediments, and as a result, patients and providers are left overwhelmed by the sheer volume of recommendations. Shared decision-making regarding priority-setting with the use of PtDAs may help focus care of these individuals. An interprofessional approach to SDM may also overcome the barriers to implementation of the PtDA such as time, availability and perceived power imbalance. Adhering to principles of user-centered design, this toolkit will be developed and refined to assess the feasibility of this approach. Given the growing prevalence of diabetes and multimorbidity, effectively bridging the knowledge to practice gap in this area has the potential to significantly improve patient-important outcomes, healthcare delivery and system sustainability.