Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus - Type 2
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: In a pragmatic randomized trial, eligible participants who complete a baseline assessment will be randomly assigned to either a basic needs navigation intervention or usual care.Masking: Single (Investigator)Masking Description: Survey administrators also will be blinded to individual participant's study group assignment.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
Type 2 diabetes affects over 29 million US adults, with a disproportionate burden of disease borne by low-income populations. Effective self-management requires attention, planning, follow-through and consistent performance of multiple health behaviors to prevent negative health outcomes. For low-in...
Type 2 diabetes affects over 29 million US adults, with a disproportionate burden of disease borne by low-income populations. Effective self-management requires attention, planning, follow-through and consistent performance of multiple health behaviors to prevent negative health outcomes. For low-income individuals, though, health improvement is often superseded by the drive to fulfill basic needs such as food, housing, personal safety, and money for necessities. Having unmet basic needs can overwhelm a person's ability to maintain health behaviors. Prior research has demonstrated that with more unmet basic needs, low-income individuals are less likely to even remember or act on a referral for needed health services. However, when unmet needs are resolved and/or people have a personal navigator to help, the likelihood of acting on a health referral significantly increases. Traditionally, patient navigators help coordinate care, manage disease or promote screening and preventive behaviors. This study will expand the role of navigators to include identifying and resolving unmet basic needs, which is expected to facilitate behavior change and improve health outcomes. This approach will be tested in a pragmatic randomized trial conducted in partnership with Louisiana Healthcare Connections, the largest Medicaid managed care plan in Louisiana. This study will test the effectiveness of a basic needs navigation intervention compared to usual care among 500 adults (ages 18-75) with Medicaid, type 2 diabetes, and 1 or more unmet basic needs. The primary hypothesis is that intervention participants will have a greater reduction (M=0.5%) in HbA1c pre-post compared with usual care participants. Consistent with the study's conceptual model, the effects of unmet basic needs on barriers to self-care (e.g., attention, stress, sleep), health behaviors (e.g., glucose monitoring, diet, clinical screenings) and health outcomes (e.g., emergency department utilization, hospitalization, quality of life) will be examined. Louisiana Healthcare Connections will identify eligible members for study recruitment and provide basic needs navigation for 6 months. The research team will recruit, enroll, randomize, and survey study participants by phone at baseline and 3-, 6- and 12-month follow up. HbA1c data will be obtained from electronic medical records to assess change.
Tracking Information
- NCT #
- NCT03940209
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Louisiana Healthcare Connections
- Investigators
- Not Provided