Care Navigator Support for Younger Latinx Adults With Type 2 Diabetes

Study Overview
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Brief Summary
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The study proposes to rigorously evaluate a proactive, culturally responsive care navigator intervention targeting younger-onset Latinx individuals with a new T2D diagnosis (AURORA [Active Outreach to Younger Latinx]) within Kaiser Permanente Northern California (KPNC).

Detailed Description
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The study has three primary objectives: 1) learn what is required to create and sustain a care navigator workforce and document our experience hiring a care navigator for the study, 2) implement and evaluate the AURORA strategy within KPNC, and 3) refine and adapt the AURORA strategy for future Kaiser Permanente (KP) wide dissemination. The AURORA strategy centers on a care navigator who will proactively conduct three telemedicine visits tailored to Latinx adults with early onset type 2 diabetes (T2D, defined as age <45 years). The AURORA strategy will conducted with the following five goals: 1) assessment of familiarity and use of T2D care within KP, 2) assessment of individual's self-management support needs, 3) motivational interviewing to support behavior change, 4) pragmatic skills training, including use of crucial technologies to support self-management, and 5) matching member's needs with existing KPNC T2D resources.

Official Title
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A Randomized Trial of Care Navigator to Support Younger Latinx Adults Newly Diagnosed With Type 2 Diabetes (AURORA)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: AURORA Care Strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: KPNC member, age >20 and age <45 with New clinical diagnosis of T2D within the prior 1-8 months HbA1c≥8%. If the study team are having trouble recruiting an adequate sample, the study team may lower the HbA1c threshold to ≥7.5% Proficient (written and spoken) in English or Spanish Exclusion Criteria: Pregnant women Type 1 Diabetes

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study team will conduct a patient-level randomized, parallel-group pragmatic trial of usual care vs. the AURORA care strategy among Latinx members (ages 18-44), recently diagnosed with T2D with a diagnosis HbA1c ≥8% (n=102/study arm). Outcomes assessed at 6 months post-enrollment will include HbA1c changes, medication initiation and adherence, and changes in patient-reported measures (e.g., self-efficacy).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AURORA Care Strategy<br>Participants will receive the AURORA Care Strategy in addition to their usual diabetes care. | Behavioral: AURORA Care Strategy<br>* Participants will be invited to partake in three telemedicine visits with the care navigator during the months following diagnosis. The visits center around proactive and tailored T2D self-management support.<br>|
| No Intervention: Usual Care<br>No intervention will be employed. This arm will continue to receive their usual diabetes care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between study arms in HbA1c change 6-months following enrollment | Change in HbA1c will be assessed using HbA1c values obtained through routine care, with the most recent HbA1c preceding study enrollment and the HbA1c value closest to 6-months following enrollment used to assess HbA1c change. | 6-months following enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare contact | Differences in healthcare contact with members of the T2D diabetes care team, including care manager, PCPs, educators. | 6-months following enrollment | 
| Completion of recommended HbA1c monitoring | Completing HbA1c labs | 6-months following enrollment | 
| T2D-related medication initiation | Initiation of T2D-related medication | 6-months following enrollment | 
| T2D-related medication adherence | Adherence to T2D-related medication | 6-months following enrollment | 
| Use of remote glucose monitoring to measure glucose levels | Use of a remote glucose monitoring to measure glucose levels | 6-months following enrollment | 
| Participant-reported measures: Confidence in Accessing Care | Assessed at 3-month survey | 3-months following enrollment | 
| Participant-reported measures: Diet and Exercise | Assessed at 3-month survey | 3-months following enrollment | 
| Participant-reported measures: Self-efficacy for diabetes | Assessed at 3-month survey | 3-months following enrollment | 
| Participant-reported measures: Motivation and locus of control | Assessed at 3-month survey | 3-months following enrollment | 
| Participant-reported measures: Diabetes distress | Assessed at 3-month survey | 3-months following enrollment | 
| Participant-reported measures: Diabetes stigma | Assessed at 3-month survey | 3-months following enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Care Navigator, Latinx