Development and Feasibility Testing of DM-BOOST Intervention.

Daniel Amante

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Usual Care; Behavioral: Diabetes BOOST

Study type: Interventional

Funder types: Other

Identifiers

NCT04710940

H00017902

Details and patient eligibility

About

DM-BOOST uses clinical informatics tools to identify types of patients with gaps in diabetes care and deploy tailored, proactive outreach methods rooted in behavioral economics to nudge them towards increased engagement with diabetes self-management training and leverage patient-facing technologies to enhance longitudinal patient self-management support.

Full description

In DM-BOOST, the Principal investigator will deploy a mixed-methods, patient-centered approach to intervention development and initiate a multiphase optimization strategy (MOST) to learn how to maximize patient engagement and support of self-management training. In this pilot, study team will complete the first phase (Preparation), and initiate feasibility piloting of the second phase (Optimization). Completion of optimization and MOST's final phase (Evaluation), will occur in a subsequent project.

In the preparation phase, Principal investigator will first analyze EHR and claims data in the UMCCTS data lake to identify sociodemographic characteristics associated with gaps in diabetes care to develop patient persona archetypes (Aim 1). Next, Principal investigator will selectively recruit patients of identified persona types as consultants, elicit stakeholder feedback during community engagement studios and conduct usability testing to iteratively design the intervention (Aim 2). Study team will then conduct a feasibility pilot (Aim 3) to assess user experience of the intervention implementation and collect exploratory outcome data to be used to inform a subsequent, complete optimization trial.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults (age 18+)
• Cognitively able to consent (Aims 2 and 3)
• Diagnosed with type 2 diabetes (Aims 1-3)
• Receive primary care at UMMHC in past 12 months at time of initial analysis (Aims 1-3)
• English speaking (Aims 2 and 3)
• Have access to patient portal or a smart phone (Aim 3)

Exclusion criteria

• Adults unable to consent (lacking cognitive capacity) (Aims 2 and 3)
• Individuals who are not yet adults (infants, children, teenagers) (Aims 1-3)
• Pregnant women (Aims 1-3)
• Prisoners (Aims 1-3)
• Non-English speaking (Aims 2 and 3)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Intervention - Diabetes BOOST

Experimental group

Description:

Intervention group participants will complete a baseline survey, receive a referral to DSMT from the research team, a mailed welcome letter and self-care education sent via a series of personalized patient portal secure messages, text messages, and video call. They will be sent text messages with information about one of the American Association of Diabetes Educators 7 self-care behaviors and will receive encouragement to author their own self-management behavioral goals. Participants will also complete a telehealth training video call with research staff and review the goals that the participant replied with. The participant will then be encouraged to send a patient portal message to their DSMT CDCES that includes their personalized goals prior to their scheduled DSMT session. They will then complete a 3-month follow-up survey and qualitative interview.

Treatment:

Behavioral: Diabetes BOOST

Usual Care

Active Comparator group

Description:

Comparison Group participants will complete a baseline survey, receive a DSMT referral request from research team to their primary care provider and a mailed welcome letter. The mailed letter will welcome the participant to the study and contain general information about diabetes self-care behaviors and goal setting. They will complete a DSMT session. They will then complete a 3-month follow-up survey and qualitative interview.

Treatment:

Behavioral: Usual Care