Development and Feasibility Testing of DM-BOOST Intervention.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2024-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The purpose of this study is to develop and usability test a patient-centric intervention designed to improve implementation of diabetes self-management training. To accomplish this, 3 specific aims will be completed.

Aim 1 - Retrospective data from the UMass Medical School EHR data repository will be analyzed to identify different clusters of patients with diabetes.

Aim 2 - To facilitate a patient-centric design of the DM-BOOST intervention, Patient Research Expert Panel (PREP) members (n\</=10) will be recruited from various patient types identified in Aim 1 (Aim 2a), participate in Community Engagement Studios to inform intervention conceptualization (Aim 2b) and usability test the intervention (Aim 2c).

Aim 3 - The intervention will be pilot tested in n\</=70 patients with type 2 diabetes (T2D). Participants will be randomized to either intervention or comparison groups.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

After completing the informed consent, study staff will enter the participant's information into pre-populated REDCap identification numbers. This will assign allocation based on the randomization table. Using this technique, participants will be blinded to allocation. However, research staff will not be blinded to provide personalized training for intervention and control. The investigator will be blinded to randomization for all participants during the study.

Study Groups

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Intervention - Diabetes BOOST

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.

Group Type EXPERIMENTAL

Diabetes BOOST

Intervention Type BEHAVIORAL

Participants will receive supportive care using technology for DSMT in addition to usual care.

Usual Care

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Participants will receive usual care for DSMT.

Interventions

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Diabetes BOOST

Participants will receive supportive care using technology for DSMT in addition to usual care.

Intervention Type BEHAVIORAL

Usual Care

Participants will receive usual care for DSMT.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes