Adults with type 2 diabetes mellitus often struggle with their antihyperglycemic medication regimens. To improve medication management, providers must ensure that their patients understand potential benefits, harms, and burdens of available options and elicit patients' preferences and barriers to taking medications. Patients who are actively involved in treatment decision making tend to be more satisfied with their health care, be more adherent to treatment, and have improved clinical outcomes (13). Such discussions, however, can be too time-consuming for clinic visits. For inner-city low-income African American and Latino adults, low health literacy and limited English proficiency are often additional barriers (4) that reduce the exchange of information and decrease patient participation during primary care visits (58). This contributes to less optimal treatment decisions and lower patient satisfaction, leading to poor medication adherence and outcomes (3, 911). There is therefore an urgent need for cost-effective approaches to enable low-resource health systems to help these high-risk populations gain information and decision support so that they can more actively participate in and improve satisfaction with their treatment decision making. Since 2000, the REACH (Racial and Ethnic Approaches to Community Health 2010) Detroit Partnership, a coalition of community, health system, and academic partners, has used community-based participatory research principles to guide development, implementation, and evaluation of interventions to meet this need among African American and Latino adults with diabetes in Detroit, Michigan. These interventions have built on evidence that community health workers (CHWs) are effective in improving diabetes outcomes, particularly among racial and ethnic minority communities (12). CHW interventions train community members to work as bridges between their ethnic, cultural, or geographic communities and health care providers (13). Two cohorts of participants in our previous CHW-led diabetes self-management support interventions improved hemoglobin A1c (HbA1c) levels and diabetes distress compared with usual care (14, 15). An important next step in increasing the potential effect of CHWs and other lay health care workers is to develop and test effective tools they can use to better present evidence-based information to patients and to help patients make better self-management decisions (16). Little is known about the effectiveness of different approaches for nontraditional care providers, such as CHWs, to deliver health information to ethnic minority and low-literacy populations (17). By definition, CHWs and other lay workers do not have medical expertise and thus rely on effectively sharing printed educational and support materials with patients as part of their coaching and counseling efforts. Decision aids can increase satisfaction with treatment decisions and result in treatments that better reflect patients' preferences (18, 19). There is also evidence that tailored health messages are more effective than generic group messages (20, 21), including for patients with diabetes (22, 23). Tailoring individualizes information and behavior change strategies to reach each person based on characteristics unique to that person derived from an individual assessment and related to the outcome of interest (24). Software programs that are being developed to automatically embed tailored content into portable e-health Web applications show promise in improving health behaviors and outcomes (25, 26). To date, however, most e-health applications have been designed for use by patients with relatively high literacy and the skills to navigate them (27). Do more sophisticated, tailored, interactive e-health tools increase the effectiveness of CHW outreach with underserved patients compared with reliance on printed educational materials alone? We addressed this question by developing and evaluating a personally tailored, interactive diabetes medication decision aid (iDecide [in English] or iDecido [in Spanish]) designed for CHWs to deliver on tablet computers with 3G wireless access to African American and Latino adults with diabetes and low health literacy. We then evaluated the effectiveness of iDecide in improving key diabetes outcomes compared with CHW delivery of the same evidence-based information, without tailoring, through print consumer booklets developed by the Agency for Healthcare Research and Quality (AHRQ). Methods Setting This study was developed and implemented by using community-based participatory research principles (28) in partnership with the REACH Detroit Partnership and the Community Health and Social Services Center (CHASS), a federally qualified health center in Southwest Detroit serving more than 13000 patients with 47099 visits in 2012 (29). The University of Michigan and CHASS institutional review boards approved the study. Content of AHRQ Consumer Guides The AHRQ guides (Pills for Type 2 Diabetes and Premixed Insulin for Type 2 Diabetes) (30, 31) provide information on diabetes and summarize the effectiveness of currently available medication classes (oral and insulin) on HbA1c. They also provide information on administration methods, costs, medication adverse effects, risks for diabetes complications, suggested questions to discuss with health care providers, and prompts to make notes of any questions for the doctor. The booklets include pictures of patients and tables and graphs summarizing information. Content of iDecide The development process and content of the iDecide program have been described in detail elsewhere (32). Briefly, we used community-based participatory research and user-centered design (33, 34) principles to iteratively develop and refine the iDecide tool. iDecide is available in English and Spanish, can be delivered via tablet computers, and enables navigation by the CHW and participant to selectively explore issues most important to the participant. The iDecide program is organized into 4 main sections and includes the same content as the AHRQ consumer guides. However, its information is presented in a more graphical style suited to patients with low literacy. Table 1 summarizes key differences between the presentation of information in iDecide and the printed materials. The first section illustrates, through animations, how diabetes affects the way glucose is processed in the body and how different medication classes, foods, and physical activity affect blood glucose. The second section includes pictographs showing participants' own risk for diabetes complications (tailored according to their baseline HbA1c) and enabling participants to explore how their risk for different complications changes with their HbA1c levels. In the third section, participants review their current diabetes medications and barriers to taking the medications they had reported on the baseline survey. This section includes an interactive issue card approach to help elicit patient preferences and priorities about different medication characteristics (for example, cost, adverse effects, effects on weight, and dosing schedules) (22, 35). The fourth section prompts participants to set goals and develop specific action plans to address identified barriers or other concerns and identify specific questions and concerns to discuss with their doctor about their medications or making lifestyle changes. Personal information from the baseline assessment is interwoven throughout the program (high-depth tailoring within sentences). Motivational interviewingbased, tailored discussion prompts encourage autonomy-supportive CHWpatient interactions at key points with open-ended questions and values exploration to help participants discover their motivation, overcome barriers to change, and develop an action plan (36). Table 1. Comparison of Content and Mode of Delivery Between the iDecide Study Group and the Printed Materials Group Recruitment and Randomization From September 2011 to August 2012, potentially eligible participants were identified from a computer-generated list of CHASS patients with physician-diagnosed type 2 diabetes. Inclusion criteria required a HbA1c value greater than 7.5% in the previous 6 months or expressed concerns about current diabetes medications during the screening assessment. Exclusion criteria were age younger than 21 years, terminal health conditions, self-reported alcohol or drug abuse, and conditions (such as blindness and dementia) that would impede meaningful participation. Pregnant women and individuals who reported that they could not be contacted by telephone were also excluded. Introductory letters were sent in timed batches. Research staff then telephoned patients and screened them for eligibility. Interested eligible patients met with research staff, who facilitated completion of written informed consent, administered baseline surveys in English or Spanish, and measured HbA1c and blood pressure. Participants received a stipend of $20 after each assessment. Within 1 to 14 days, participants were scheduled for a visit with a CHW (at home, the clinic, or another agreed-upon place). At the beginning of the CHW visits, participants were registered into the iDecide program and randomly assigned by the computer program, through use of a random-sequence algorithm, into 1 of 2 study groups. There were no differences between the steps to participate in either study group. Patients, research staff, and CHWs were blinded to randomization results through completion of all baseline measures up to the start of the intervention. Data assessors remained blinded to group assignment throughout the study. CHW Intervention for Both Study Groups All participants received an initial one-on-one, face-to-face session with a CHW and a copy of the printed materials to take home. The iDecide sessions lasted approximately 2 hours, and the sessions using printed materials lasted appr
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