Background Person-centered care is critical for delivering high-quality diabetes care. Shared decision making (SDM) is central to person-centered care, and in diabetes care, it can improve decision quality, patient knowledge, and patient risk perception. Delivery of person-centered care can be facilitated with the use of patient decision aids (PtDAs). We developed MyDiabetesPlan, an interactive SDM and goal-setting PtDA designed to help individualize care priorities and support an interprofessional approach to SDM. Objective This study aims to assess the impact of MyDiabetesPlan on decisional conflict, diabetes distress, health-related quality of life, and patient assessment of chronic illness care at the individual patient level. Methods A two-step, parallel, 10-site cluster randomized controlled trial (first step: provider-directed implementation only; second step: both provider- and patient-directed implementation 6 months later) was conducted. Participants were adults 18 years and older with diabetes and 2 other comorbidities at 10 family health teams (FHTs) in Southwestern Ontario. FHTs were randomly assigned to MyDiabetesPlan (n=5) or control (n=5) through a computer-generated algorithm. MyDiabetesPlan was integrated into intervention practices, and clinicians (first step) followed by patients (second step) were trained on its use. Control participants received static generic Diabetes Canada resources. Patients were not blinded. Participants completed validated questionnaires at baseline, 6 months, and 12 months. The primary outcome at the individual patient level was decisional conflict; secondary outcomes were diabetes distress, health-related quality of life, chronic illness care, and clinician intention to practice interprofessional SDM. Multilevel hierarchical regression models were used. Results At the end of the study, the intervention group (5 clusters, n=111) had a modest reduction in total decisional conflicts compared with the control group (5 clusters, n=102; −3.5, 95% CI −7.4 to 0.42). Although there was no difference in diabetes distress or health-related quality of life, there was an increase in patient assessment of chronic illness care (0.7, 95% CI 0.4 to 1.0). Conclusions Use of goal-setting decision aids modestly improved decision quality and chronic illness care but not quality of life. Our findings may be due to a gap between goal setting and attainment, suggesting a role for optimizing patient engagement and behavioral support. The next steps include clarifying the mechanisms by which decision aids impact outcomes and revising MyDiabetesPlan and its delivery. Trial Registration ClinicalTrials.gov NCT02379078; https://clinicaltrials.gov/ct2/show/NCT02379078

The primary outcome is to evaluate the relationship between diabetes distress and decisional conflict regarding diabetes care in patients with diabetes and two or more comorbidities. Secondary outcomes include the relationships between diabetes distress and quality of life and patient perception of chronic illness care and decisional conflict. RESEARCH DESIGN AND METHODS This was a cross-sectional study of 192 patients, ‡18 years of age, with type 2 diabetes and two or more comorbidities, recruited from primary care practices in the Greater Toronto Area. Baseline questionnaires were completed using validated scales: Diabetes Distress Scale (DDS), Decisional Conflict Scale (DCS), Short-Form Survey 12 (SF-12), and Patient Assessment of Chronic Illness Care (PACIC). Multiple linear regression models evaluated associations between summary scores and subscores, adjusting for age, education, income, employment, duration of diabetes, and social support. RESULTS Most participants were >65 years old (65%). DCS was significantly and positively associated with DDS (b = 0.0139; CI 0.00374-0.0246; P = 0.00780). DDS-emotional burden subscore was significantly and negatively associated with SF-12-mental subscore (b =23.34; CI 24.91 to 21.77; P < 0.0001). Lastly, DCS was significantly and negatively associated with PACIC (b = 26.70; CI 29.10 to 24.32; P < 0.0001). CONCLUSIONS We identified a new positive relationship between diabetes distress and decisional conflict. Moreover, we identified negative associations between emotional burden and mental quality of life and patient perception of chronic illness care and decisional conflict. Understanding these associations will provide valuable insights in the development of targeted interventions to improve quality of life in patients with diabetes.

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Objective To assess the relationship between empathic communication, shared decision-making, and patient sociodemographic factors of income, education, and ethnicity in patients with diabetes. Research Design and Methods This was a cross-sectional study from five primary care practices in the Greater Toronto Area, Ontario, Canada, participating in a randomized controlled trial of a diabetes goal setting and shared decision-making plan. Participants included 30 patients with diabetes and 23 clinicians (physicians, nurses, dietitians, and pharmacists), with a sample size of 48 clinical encounters. Clinical encounter audiotapes were coded using the Empathic Communication Coding System (ECCS) and Decision Support Analysis Tool (DSAT-10). Results The most frequent empathic responses among encounters were “acknowledgement with pursuit” (28.9%) and “confirmation” (30.0%). The most frequently assessed DSAT components were “stage” (86%) and knowledge of options (82.0%). ECCS varied by education (p=0.030) and ethnicity (p=0.03), but not income. Patients with only a college degree received more empathic communication than patients with bachelor’s degrees or more, and South Asian patients received less empathic communication than Asian patients. DSAT varied with ethnicity (p=0.07) but not education or income. White patients experienced more shared decision-making than those in the “other” category. Conclusions We identified a new relationship between ECCS, education and ethnicity, as well as DSAT and ethnicity. Limitations include sample size, heterogeneity of encounters, and predominant white ethnicity. These associations may be evidence of systemic biases in healthcare, with hidden roots in medical education.

BACKGROUND Person-centred care is critical to delivering high quality diabetes care. Shared decision-making is central to person-centred care, and in diabetes care, improved decision quality, patient knowledge and patient risk perception. Delivering person-centred care can be facilitated with the use of patient decision aids. We developed MyDiabetesPlan, an interactive shared decision-making and goal-setting patient decision aid designed to help individualize care priorities and to support an interprofessional approach to SDM. OBJECTIVE To assess the impact of MyDiabetesPlan (an interactive online shared decision-making and goal-setting aid) on decisional conflict, diabetes distress, health-related quality of life and patient assessment of chronic illness care. METHODS A two-step, parallel 10-site clustered randomized controlled trial (first step: provider-directed implementation only; second step: both provider- and patient-directed implementation 6 months later). Population: Adults aged 18 and older with diabetes and 2 other comorbidities at 10 family health teams in Southwestern Ontario. Intervention: MyDiabetesPlan was integrated into intervention practices, and clinicians (first step) then patients (second step) were trained on its use. Control participants received Diabetes Canada resources. Data collection: Participants completed validated questionnaires at baseline, 6 and 12 months. Outcomes: Primary outcome was decisional conflict; secondary outcomes were diabetes distress, health-related quality of life, chronic illness care and clinician intention to practice interprofessional shared decision-making. Analysis: Multilevel hierarchical regression models were used. RESULTS At study end, the intervention group (n=111) had a greater reduction in total decisional conflict compared to the control group (n=102) (-3.5, 95% confidence interval (CI) -6.6 to -0.5). While there was no difference in diabetes distress nor health-related quality of life, there was an increase in patient assessment of chronic illness care (0.7, 95% CI 0.4 to 1.0). CONCLUSIONS Our findings may be due to a gap between goal setting and attainment, suggesting a role for optimizing patient engagement and behavioral supports. Next steps include clarifying the mechanisms by which decision aids impact outcomes and revising MyDiabetesPlan and its delivery. CLINICALTRIAL Clinicaltrials.gov NCT02379078 Date of Registration: February 11, 2015