Enhancing Self-Management Support in Diabetes Through Patient Engagement

Study Overview
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Brief Summary
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The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. 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. Despite its recognized importance, SMS programs for diabetes continue to demonstrate limited effectiveness in the real-world of primary care. SMS is comprised of two complementary and interactive components: (1) patient engagement (e.g., the process of eliciting and responding to patients emotions and motivations related to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals, creating action plans). While several sophisticated SMS programs have been developed for T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely ignoring unique aspects of the patient context that drive and maintain health behavior. Considerable clinical research suggests that the addition of a structured, evidenced-based program of patient engagement can maximize the effectiveness of SMS programs for patients with T2DM in primary care. To date there has been no systematic study of the degree to which fully integrating enhanced patient engagement as part of SMS will increase the initiation and maintenance of behavior change over time, and for which kinds of patients enhanced patient engagement is essential. To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program that includes a practical, time-efficient patient engagement protocol, to create a program with an integrated and comprehensive approach to SMS, called Enhanced Engagement CTH (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard to self-management behaviors and glycemic control in resource-limited community health centers, where vast numbers of patients with T2DM from ethnically diverse and medically vulnerable populations receive their care. The investigators will use an effectiveness-implementation hybrid design, employing the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to test these two SMS programs for T2DM. This will provide critical information that will support dissemination and implementation of effective SMS programs in resource-limited primary care settings, serving diverse and medically vulnerable populations with much to gain from improved SMS.

Detailed Description
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This is a two-arm, 14 month pragmatic cluster randomized trial to evaluate the added benefit of EE-CTH relative to CTH for patients with T2DM in primary care. Primary care practices (not patients) will be randomly assigned to receive and deliver CTH or EE-CTH in an innovative effectiveness-implementation hybrid design. Using the RE-AIM framework, the investigators will evaluate program effectiveness in a real world setting, while at the same time gathering information on program reach, adoption, implementation and maintenance. CTH and EE-CTH practice trainings and delivery will each follow separate and standardized protocols, with support provided to practices through staff training, ongoing supervision and case presentations, and a practice improvement team assisted by a practice facilitator to address issues of staffing and patient flow. Practice training and facilitation notes, in conjunction with feedback from patient advisory councils, will be captured and integrated to identify barriers and facilitators to the implementation process and inform dissemination efforts. Beyond the requirements of the study, practices will be permitted to use EE-CTH or CTH with other patients as wished, which will enable the investigators to document the program's reach within the practice. Patients in both study arms will receive the intervention at a minimum of two primary care appointments (baseline and follow-up between 6 and 12 months).

Official Title
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Enhancing Self-Management Support in Diabetes Through Patient Engagement

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Enhanced Engagement Protocol for CTH (EE-CTH)
* Behavioral: Connection to Health (CTH)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes; Diagnosed and receiving care at participating practices for at least 12 months; Able to read in English or Spanish (at least 6th grade level). Exclusion Criteria: Not meeting all inclusion criteria

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Connection to Health (CTH)<br>CTH is a comprehensive SMS program that focuses on behavior change. CTH utilizes web-based interactive behavior change technology, based on a logic model of behavior and maintenance that is informed by social-cognitive and social ecological theories. Prior to diabetes visits with a clinician, health educator, or care manager, patients complete a pre-visit CTH assessment at their practice through a tablet computer or computer kiosk. CTH assesses multiple diabetes management behaviors (diet, physical activity, medication adherence, alcohol and tobacco use, stress, mood) using brief assessment measures, each with cut-points highlighting areas of deficit. Action planning plays a central role, through a web-based platform that allows the patient and health care team to select and set goals collaboratively. | Behavioral: Connection to Health (CTH)<br>* CTH is a comprehensive SMS program that focuses on behavior change.<br>|
| Experimental: Enhanced Engagement Protocol for CTH (EE-CTH)<br>EE-CTH seamlessly integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol specifically designed to enhance patient engagement in SMS activities. Key components of MI have been incorporated into a practical and systematic engagement protocol that includes: (1) acknowledging the patient's point of view; (2) identifying and labeling the patient's ambivalence (both the good reasons for making the change and the good reasons for not making the change); (3) evaluating whether change is really worth the effort; (4) identifying, reflecting and labeling accompanying feelings and concerns about change; and (5) establishing a small and meaningful goal by the end of the encounter. | Behavioral: Enhanced Engagement Protocol for CTH (EE-CTH)<br>* EE-CTH integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycated haemoglobin) | Percentage HbA1c | Change from baseline to follow-up (6 to 12 months) | 
| High fat food | Amount of high fat food consumed weekly adapted from the Summary of Diabetes Self-Care Activities | Change from baseline to follow-up (6 to 12 months) | 
| Physical activity | Number of minutes of participation in physical activity from the International Physical Activity Questionnaire | Change from baseline to follow-up (6 to 12 months) | 
| Number of days missed medications | Number of days missed missing one or more medications in the past 14 days | Change from baseline to follow-up (6 to 12 months) | 
| Medication adherence | Frequency of reasons for missing medications. | Change from baseline to follow-up (6 to 12 months) | 
| Fruit and vegetable intake | Number of daily fruit and vegetable servings adapted from the Summary of Diabetes Self-Care Activities | Change from baseline to follow-up (6 to 12 months) | 
| Sugar-sweetened beverages | Number of daily sugar-sweetened beverages from the Starting the Conversation Measure | Change from baseline to follow-up (6 to 12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related distress | Modified from the Diabetes Distress Scale | Change from baseline to follow-up (6 to 12 months) | 
| Depression symptoms | Patient Health Questionnaire (PHQ8) Score | Change from baseline to follow-up (6 to 12 months) | 
| Weight | Weight (pounds) | Change from baseline to follow-up (6 to 12 months) |