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Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries

  • Clinicaltrials.gov identifier

    NCT03940209

  • Recruitment Status

    Enrolling by invitation

  • First Posted

    May 7, 2019

  • Last update posted

    May 10, 2021

Study Description

Brief summary:

This pragmatic randomized trial 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. Basic needs includes having such things as adequate food, housing, personal safety, and money for necessities. The primary study hypothesis is that participants who receive navigation to address unmet basic needs will have a greater reduction (M=0.5%) in HbA1c pre-post compared with participants receiving usual care. 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.

  • Condition or Disease:Diabetes Mellitus, Type 2
  • Intervention/Treatment: Behavioral: Basic needs navigation
  • Phase: Phase 2

Detailed 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 For low-income individuals, though, health improvement is often superseded by the drive to fulfill basic needs such as food, housing, personal safety, and money for necessities.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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 500 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention 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)
  • Primary Purpose: Supportive Care
  • Official Title: Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries
  • Actual Study Start Date: November 2019
  • Estimated Primary Completion Date: June 2023
  • Estimated Study Completion Date: June 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Basic needs navigation
Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan (usual care) as well as a navigator for 6 months to address any unmet basic needs, provide instrumental and emotional social support, and improve self-management capabilities.
Behavioral: Basic needs navigation
Navigators will help participants address unmet basic needs for 6 months by telephone. Either party can initiate a call. On every call, navigators will: (1) review unmet needs previously reported (baseline survey for first call) and ask participants to report new needs; (2) jointly prioritize among multiple needs based on severity and resource availability; (3) identify community resources that could help solve the problem; (4) evaluate eligibility for those resources; and (5) prepare participants to interact with service agencies and/or act as an advocate on their behalf. On each subsequent call, navigators will review progress toward resolving those needs, assess emergent needs, and adapt priorities accordingly. Navigators will provide instrumental and emotional social support through regular friendly contact, and will attempt to reduce barriers to needs resolution to improve stability and security for participants longer-term.

Outcome Measures

  • Primary Outcome Measures: 1. HbA1c [ Time Frame: 12 months ]
    Glycated haemoglobin (A1c) values will be abstracted from participants' medical record lab reports reflect average plasma glucose concentration over 8-12 weeks
  • Secondary Outcome Measures: 1. Health-related Quality of Life [ Time Frame: 12 months ]
    Physical and mental summary (subscale) scores from the Short Form-12 item (SF-12) self-report survey instrument will be created following standard scoring guides. Responses are weighted (using regression weights from a general United States population) then summed then standardized to a mean of 50 and standard deviation of 10 (Range 0-100). Higher scores indicate better health status and better health-related quality of life.

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

- Medicaid beneficiary

- Member of Louisiana Healthcare Connections

- Age 18-75 years old

- Diagnosed with type 2 diabetes

- Had a HbA1c test in the 3-4 months prior to baseline assessment

Exclusion Criteria:

- HbA1c <7.0 in the 3-4 months prior to baseline assessment - Enrolled in case management at Louisiana Healthcare Connections in the 3 months prior to baseline assessment - Are currently pregnant or have only been diagnosed with gestational diabetes at baseline - Have cognitive or hearing impairments that significantly impede participation in telephone-based survey and intervention protocols. - Individuals not living independently (e.g., nursing homes, rehab or correctional facilities)

Contacts and Locations

Contacts

Locations

United States, Missouri
Washington University
Saint Louis

Sponsors and Collaborators

Washington University School of Medicine

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Louisiana Healthcare Connections

More Information