Background
Most patients with type 2 diabetes mellitus (T2DM) in the U.S. receive diabetes care in primary care settings, which are undergoing rapid transformations due to the need to improve quality and decrease costs. The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly employed to support better T2DM outcomes in primary care [
1‐
7]. Self-management Support (SMS) is a core component of both the PCMH and CCM, and focuses on the central role of patients in managing their illness by engaging with and adopting healthy behaviors that promote optimal clinical outcomes [
6,
8‐
10]. SMS typically targets improvements in medication adherence, diet, exercise, and other risk-related behaviors; all of which are crucial for maintaining good glycemic control and reducing the risks of diabetes-related complications. Despite its recognized importance, SMS programs for diabetes continue to demonstrate limited effectiveness and sustainability in the real world of primary care [
11,
12]. Primary-care physicians have been unable to comprehensively and consistently address diabetes self-management within an efficient and systematic SMS framework for several interrelated reasons: they are often overwhelmed by competing demands, poorly trained in assessing and intervening with health behavior change, lack practice systems for implementing change and quality improvement, and receive inadequate reimbursement for time spent in SMS activities [
13‐
16].
Few tools are available to assist practices with self-management support. Interactive behavior-change technology (IBCT) can facilitate the adoption of crucial SMS interventions in primary care for patients with diabetes and related health risk behaviors [
17‐
20]. Compared with traditional, unstructured programs, technological options for delivery have the advantage of increased convenience and accessibility, and may provide individualized support and resources necessary for initiating and maintaining healthful lifestyles, especially when they include non-automated options to address patient preference and permit patient tailoring [
19‐
22] There is strong evidence that Internet-based programs can effectively promote health behaviors to support diabetes self-management, [
23] such as healthful eating/weight management, [
24‐
27] increasing physical activity, [
28‐
30] reducing depression symptoms, and smoking cessation [
31,
32]. Multiple randomized trials have been conducted using IBCT programs for diabetes self-management with positive results [
33,
34]. However, most current IBCT self-management programs contain several limitations to translation into primary care settings: [
35,
36] they are largely informational, they require high literacy, they are limited to simple health-risk assessment without goal setting, action planning or follow-up, they fail to provide physician decision support, and they do not emphasize patient-physician collaboration. Furthermore, most are exclusively automated and do not take into account the preference of many patients and clinicians for different modes of assessment and intervention.
Connection to Health (CTH) is a comprehensive, evidence-based SMS program that supports behavior change through IBCT. The CTH logic model is informed by social-cognitive [
37‐
39] and social-ecological [
40‐
42] theories and is inclusive of the evidence based principles for implementing SMS in primary care [
43]. Multiple intervention components work together to promote enhanced, tailored diabetes management, which is linked to positive health outcomes [
44‐
46]. Patients complete a CTH assessment that covers multiple issues related to diabetes and co-morbid conditions using state-of-the-art measures, each with cut-points defining a flagged area for concern. Patients receive an immediate summary, along with profiles from prior assessments to denote change over time. Patients are asked to review the summary and identify areas to discuss with their care team in preparation for making an action plan. A parallel report is prepared for the clinician that also includes decision support tools and options for the clinician for each flagged area on the profile, all to assist in beginning a conversation with the patient about specific problems and how they might be addressed. Action planning plays a central role, and includes goal setting and problem solving [
47] through an automated, web-based action planning program. CTH also includes patient resources and tips to improve diabetes management. CTH is avehicle for structuring and guiding a time-effective clinical conversation between patient and the care team, enabling clinicians and patients to regularly assess, monitor, and intervene with self-management issues using a patient-centered approach that allows for practice and patient tailoring and encourages patient/care team interaction.
The simple availability of effective IBCT tools like CTH does not assure their successful implementation [
15,
16,
48‐
50]. Primary care practices are experiencing multiple pressures to see a large number of patients, to provide improved care, and to do so with very constrained reimbursement. Practices have few mechanisms to integrate new programs into routine care, which can exert major pressures on practice operations – even small changes can have substantial consequences that limit their effectiveness and sustainability [
15,
16,
48‐
50]. Adoption and implementation of new care programs varies across practices based on practice characteristics, including practice culture and change capacity, practice size, location (rural vs. urban), previous change experience, and decision-making style [
13,
14,
51].
Practice facilitation has been effective in assisting practices in implementing organizational changes such the CCM and PCMH [
52‐
58]. A facilitator can assist a practice in tailoring a new program to fit their unique practice situation, resources, and culture, improving its implementation and its sustainability over time. Practice facilitators use a motivational interviewing approach in assessing and increasing key stakeholders’ motivation for change. The practice facilitation intervention impacts the practice’s capacity for change through forming a quality improvement team, [
59] training the team in quality improvement techniques including the use of Plan-Do-Study-Act (PDSA) for rapid cycle change, planning and implementing work flow and other changes, and identifying and working to overcome barriers. The quality improvement team consists of a diverse group of representatives from the various clinician and staff roles in the practice and meets regularly to plan the adoption and implementation of programs like CTH.
This study has been designed to promote the translation of SMS into primary care practices for patients with T2DM by combining two promising lines of research; specifically, testing the effectiveness of CTH for patients with T2DM in diverse primary care practices and evaluating the impact of practice facilitation to enhance uptake and maintenance of the intervention. Our specific aims for this project are:
1. To conduct a cluster randomized trial to examine the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of CTH for patients with T2DM in primary care practices.
2. To determine the incremental benefit of brief targeted practice facilitation on the implementation of CTH in diverse primary care practices.
3. To identify key practice characteristics (e.g., practice size, organization, setting, and level of experience with practice redesign efforts) that affect CTH RE-AIM outcomes.