Development and Feasibility Testing of DM-BOOST Intervention.
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Usual CareBehavioral: Diabetes BOOST
- Registration Number
- NCT04710940
- Lead Sponsor
- Daniel Amante
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. Intervention - Diabetes BOOST 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.
- Primary Outcome Measures
Name Time Method Completion of diabetes self-management training (Aim 3) 9 months Completion of diabetes self-management training.
Intervention Acceptability (Aim 2) 1 month Patient-reported assessment of intervention acceptability via usability testing. Qualitative data collection informed by the Technology Acceptance Model with assessment of perceived usefulness, ease of use, behavioral intention to use and external factors. No quantitative data measured.
- Secondary Outcome Measures
Name Time Method Clinical utilization (Aim 3) 9 months Rate of clinical utilization as measured by number of visits per participant to primary, specialty care, and emergency/hospital care visits measured 6-months after follow-up visit.
Diabetes self-efficacy (Aim 3) 3 months Diabetes self efficacy will be measured at baseline and 3 months after enrolling in the study using the Diabetes Management Self-Efficacy Scale. Participants will provide feedback on set of questions, using a 5-point Likert scale( with 1=Strong Disagree, 2=Somewhat Disagree, 3= Neutral, 4=Somewhat Agree, 5= Strongly Agree)
Diabetes treatment satisfaction (Aim 3) 3 months Diabetes Treatment Satisfaction will be measured at 3 months after enrolling in the study using the Diabetes Treatment Satisfaction Questionnaire Change tool. Participants will be asked to share how their experience of current treatment has changed from their experience of treatment before the study began. They will answer each question by choosing 3 for Much More Satisfied Now up to -3 for Much Less Satisfied Now. (3,2,1,0,-1,-2,-3)
Diabetes self-management skills (Aim 3) 3 months Self-management skills will be measured at 3 months after enrolling in the study. Participant will be asked questions about their diabetes self-care activities during the past seven days using the Summary of Diabetes Self-Care Activities Measure
Hemoglobin A1C (HbA1C) (Aim 3) 6 months Measurement of HbA1c values to determine impact of intervention. HbA1c values at baseline visit will be compared with values at 3-6 months after participant's enrollment. These data will be obtained through EHR chart review.
Patient engagement with Diabetes Self-Management Training (Aim 3) 9 months Engagement data will be collected by research staff. It will be measured by the numbers of patients who request contact, are reached, enrolled in the study and scheduled DSMT appointment.
Trial Locations
- Locations (1)
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States