Clinical trial NCT02834923: Enhancing Self-Management Support in Diabetes Through Patient Engagement
Official title: Enhancing Self-Management Support in Diabetes Through Patient Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-07-15
Enrollment: 725
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c (glycated haemoglobin)
timeFrame: Change from baseline to follow-up (6 to 12 months)
measure: High fat food
timeFrame: Change from baseline to follow-up (6 to 12 months)
measure: Physical activity
timeFrame: Change from baseline to follow-up (6 to 12 months)
measure: Number of days missed medications
timeFrame: Change from baseline to follow-up (6 to 12 months)
measure: Medication adherence
timeFrame: Change from baseline to follow-up (6 to 12 months)
measure: Fruit and vegetable intake
timeFrame: Change from baseline to follow-up (6 to 12 months)
measure: Sugar-sweetened beverages
timeFrame: Change from baseline to follow-up (6 to 12 months)
Secondary outcomes:
measure: Health-related distress
timeFrame: Change from baseline to follow-up (6 to 12 months)
measure: Depression symptoms
timeFrame: Change from baseline to follow-up (6 to 12 months)
measure: Weight
timeFrame: Change from baseline to follow-up (6 to 12 months)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Danielle M Hessler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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citation: Hessler D, Fisher L, Dickinson M, Dickinson P, Parra J, Potter MB. The impact of enhancing self-management support for diabetes in Community Health Centers through patient engagement and relationship building: a primary care pragmatic cluster-randomized trial. Transl Behav Med. 2022 Oct 7;12(9):909-918. doi: 10.1093/tbm/ibac046.