Diabetes mellitus is a chronic, progressive disease affecting 30.3 million people in the United States [1]. In addition to being the 7th leading cause of death in the United States, diabetes contributes to serious microvascular and macrovascular complications [1]. Diabetes self-management is the cornerstone to avoiding or delaying diabetes complications, and ongoing self-management is necessary. Self-management behaviors involve an often-challenging daily diet, medication, exercise, and glucose monitoring regimen, among others, and is complicated by social determinants of health (eg, transportation and access to high-quality care). Diabetes self-management education and support (DSMES) is a crucial component of diabetes care that provides the foundation necessary to self-manage diabetes. The American Association of Diabetes Care and Education Specialists, the American Diabetes Association, and the American Academy of Family Physicians all recommend DSMES [2]. DSMES can improve outcomes in both type 1 (T1D) and type 2 diabetes (T2D), including improving hemoglobin A_1c, quality of life, diabetes distress, and healthy coping [3-6]. However, there is variation in how DSMES interventions are structured, in terms of both content and delivery, and as such, some DSMES programs may be more acceptable, feasible, and effective than others [7].

Approximately 50% of adults with T1D [8] and 90% of adults with T2D in the United States are managed in primary care settings and not in endocrinology specialty practice offices [9], and therefore often lack access to services such as DSMES. Strikingly, 75% of counties in the United States have no endocrinologists at all, while primary care can be found in 96% of US counties [10]. Especially in rural areas, many people with diabetes receive their diabetes care at primary care practices and may have to travel long distances to access DSMES when not available in their medical home. When DSMES is available, there can be a lack of fit between the curriculum, materials, or mode of delivery and the resources of rural primary care practices and communities, including a lack of staff and lack of information tailored to the resources and culture in rural communities. There is a clear need for DSMES interventions, feasible for delivery in rural settings, that can address the unique social determinants of health and cultural adaptations appropriate for people with diabetes living in rural communities.

The 2017 National Standards for DSMES recommend a multidisciplinary team delivering DSMES, a curriculum reflecting current evidence and practice guidelines, individualized plans, and sources for ongoing support [11]. Personalizing care via DSMES is critical because it allows individuals to identify how to incorporate self-management into their own daily life [12,13]. While individual DSMES may be better suited for personalized approaches to care, group sessions can be more cost-effective than individual sessions [14] and offer opportunities for peer support. However, when sessions are held over several weeks, it can be challenging for individuals to complete leading to attrition [15]. A systematic review of 118 unique DSMES interventions found that patients who receive group and individual DSMES sessions, from multidisciplinary teams, are the most effective at reducing A_1c [15]. Interventions that address the need for group and personalized care can reduce disparities in rural populations. This study will address current gaps in rural diabetes care research and a widely recognized need to enhance access to DSMES among rural populations.

National data indicate that diabetes prevalence is higher in rural areas. Rural-dwelling adults are 17% more likely to have diabetes than their urban counterparts nationally [16]. For instance, the rates of diabetes in rural eastern Colorado average 12.3% compared to the state average of 7.3% [17]. Rural populations have limited access to DSMES, and health care access is more limited in rural areas, impeded with long travel distances, as well as higher rates of poverty than those individuals in urban settings [14]. These challenges contribute to a greater risk of suboptimal diabetes management and higher rates of diabetes-related complications [18]. The Diabetes One-Day (D1D) intervention is a condensed, one-day group DSMES session delivered via telehealth by a multidisciplinary team at a diabetes and endocrinology center. Patients are encouraged to invite a care partner (family member or friend) to attend D1D given that diabetes is managed in a social context. D1D was designed to address DSMES access challenges seen with multiple-day DSMES interventions. Evidence suggests that the D1D intervention is effective for improving diabetes self-management outcomes [19,20] and is a promising intervention to address specialty care access challenges seen in rural communities. Further consideration of cultural and social adaptations to D1D (ie, a Rural D1D [R-D1D] program) is needed to ensure fit for rural communities, especially those where English and Spanish are the primary languages spoken. We describe our protocol for adapting D1D for rural primary care and implementing, evaluating, and refining the resulting R-D1D intervention.

The logic model for this project (Figure 1) depicts the process by which the D1D intervention (Box A) is adapted, implemented, and refined for rural settings (R-D1D, Box B), to promote the successful adoption and implementation by rural practices and reach to patients in the target audience (Box C). Once adopted and implemented, a future study will assess effectiveness for patient-reported and clinical outcomes at the patient level and maintenance at the practice level (Box D). That is, to achieve impact on patient-level outcomes and to be sustainable for practices, the intervention must be acceptable, appropriate, and feasible for delivery in rural primary care, be implemented well, and reach target populations. The intermediate outcomes and impact outcomes align with the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, a well-established framework for program planning and evaluation [21].

The coprimary aim of this study is to adapt the existing D1D program for use in rural communities (R-D1D). Boot Camp Translation (BCT) [22,23] will be used to partner with diverse community members, including members from Spanish-speaking communities, to adapt diabetes self-management language and tools and delivery of D1D into a culturally relevant R-D1D for rural primary care practices, patients, and care partners.

The secondary coprimary aim is to conduct a patient-level pilot randomized controlled trial (RCT) to examine the effects of R-D1D (intervention group) vs standard patient education (attention control group), guided by the RE-AIM framework. We will implement and refine the R-D1D intervention, evaluate implementation at the practice level, and evaluate reach and effectiveness at the patient level.

This study will use the BCT method to adapt the medical information, guidelines, and materials in the current D1D intervention for use with English-speaking and Spanish-speaking people living in rural eastern Colorado (R-D1D). Then, using a 1:1 type 2 hybrid trial, we will conduct a pilot test in 64 total patients from 2 practices to compare R-D1D to a standard education control. Acceptability and feasibility of R-D1D will be assessed at the patient and practice levels.

This project will take place in the High Plains Research Network, a practice-based research network of 53 primary care practices, hospitals, and communities in a 16-county region of rural eastern Colorado. Two High Plains Research Network primary care clinics will be included. To participate, clinical practices must be willing to identify and refer potential English-speaking and Spanish-speaking participants with T1D or T2D to the research team at the University of Colorado for eligibility screening and informed consent.

R-D1D will be delivered to patients who receive diabetes care at 2 practices, once in English and once in Spanish at each practice. Thus, each site will have a total of N=32 persons with disability split into 4 groups (8 English control, 8 English R-D1D, 8 Spanish control, and 8 Spanish R-D1D). For each site and language, the participants will be randomized using alternating blocks of 2 and 4.

The intervention is the adapted R-D1D from the existing D1D program. D1D was designed for adults with T1D and T2D and is delivered using a hybrid model that includes in-person small-group and individual DSMES sessions. D1D is delivered by an interdisciplinary faculty specializing in diabetes care, including a nurse practitioner, certified diabetes care and education specialist, pharmacist, exercise specialist, ophthalmology technician, chef, licensed clinical social worker, endocrinologist, and obesity medicine physician. The topics included pathophysiology, complications, screenings, laboratories, medication options, weight management, the importance of exercise, healthy eating, troubleshooting glucose levels, diabetes technology, and healthy coping with diabetes. A healthy breakfast, interactive lunch with a chef demonstration, and snacks were also provided (Multimedia Appendix 1). An emphasis on participants providing education and support to others in the group sessions was encouraged. The participants received written and digital educational materials, recipes, a copy of the Calorie King Book, and resistance bands.

We anticipate R-D1D adaptations may focus on healthy eating based on food available in rural communities, stigma surrounding mental health in rural communities as it relates to diabetes management, and program structure and timing.

R-D1D will be delivered by an interdisciplinary team of health care professionals specifically trained in the D1D program, including a nurse practitioner, physician, registered dietitian, certified diabetes care and education specialist, pharmacist, and a licensed clinical social worker. The R-D1D program will be delivered by telehealth by members of the original D1D team. An overview of the D1D curriculum that will be adapted is detailed in Multimedia Appendix 1.

Intervention group participants will meet with study staff to assess the participant’s technology literacy, test the participant’s internet connection and chosen electronic device, and provide instruction and demonstration for connecting to the videoconference platform. More than 1 meeting may be required. These meetings will be held via the same platform used for R-D1D intervention to allow the opportunity to troubleshoot directly with the participant.

The control group will receive a standard patient education handout that covers the ADCES7 self-care behaviors (healthy coping, healthy eating, being active, monitoring, taking medication, problem solving, and reducing risks) [24].

Implementation strategies refer to “methods or techniques used to enhance the adoption, implementation, and sustainability of a clinical program or practice” [25]. For this study, we will use several implementation strategies [26], including the following: (1) BCT to adapt and tailor D1D for the rural setting; and (2) technical assistance and workflow design. Grounded in the principles of community-based participatory research, BCT is a process used by partnerships of community members and academic researchers to translate medical information and guidelines into concepts and messages that partnerships believe will be relevant and actionable to local communities [27-30]. Partnerships develop materials and dissemination strategies that use and reflect local culture and assets to effectively move messages and materials to the desired audience. In the traditional BCT, community-academic partnerships are guided by the questions, “What is the message to our community?” and “How do we effectively share these messages with the community?” [31]. The process relies on the community members’ and researchers’ unique expertise, experiences, and perspectives. For this study, a modified BCT process will be used to adapt the existing D1D program for use in rural communities and primary care practices. Telehealth technical assistance will be provided by the community research liaisons or practice facilitators as needed.

The outcomes for this study are informed by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework [32]. We will use multiple methods (qualitative and quantitative) to assess select RE-AIM domains. Reach and Effectiveness are both patient-level outcomes. Reach refers to the number and percent of eligible patients who participate in the intervention, characteristics of those who participate and complete the measures, and reasons for not participating. Effectiveness refers to clinical and behavioral patient-level outcomes. Adoption, Implementation, and Maintenance are practice-level outcomes (maintenance can also refer to patient-level maintenance of health outcomes over time). Adoption refers to the number, percent, and characteristics of clinical practices who were invited to offer the intervention to their patients who participate in the study. Implementation refers to consistency of delivery of the intervention as intended (ie, fidelity), as well as practice perceptions of the acceptability, appropriateness, and feasibility of delivering the intervention in their clinical practice setting [33]. Maintenance refers to sustained effects on patient outcomes over time and to continued intervention delivery within the clinical setting beyond the study period, which will be explored in a future study.

R-D1D is designed to be completed in 1 day. Study staff will encourage patient participants to participate in the study activities (intervention, follow-up surveys, and interviews) through phone calls, text messages, and email reminders.

Data use agreements among participating organizations have been established. The study procedures were approved by the University of Utah Multiple Institutional Review Board on October 28, 2020 (IRB_00133179).