Diabetes Mellitus, Type 2
Conditions
Keywords
Care Navigator, Latinx
Brief summary
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
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.
Interventions
BEHAVIORALAURORA Care Strategy
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.
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
21 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences between study arms in HbA1c change 6-months following enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of recommended HbA1c monitoring | 6-months following enrollment | Completing HbA1c labs |
| T2D-related medication initiation | 6-months following enrollment | Initiation of T2D-related medication |
| T2D-related medication adherence | 6-months following enrollment | Adherence to T2D-related medication |
| Use of remote glucose monitoring to measure glucose levels | 6-months following enrollment | Use of a remote glucose monitoring to measure glucose levels |
| Participant-reported measures: Confidence in Accessing Care | 3-months following enrollment | Assessed at 3-month survey |
| Healthcare contact | 6-months following enrollment | Differences in healthcare contact with members of the T2D diabetes care team, including care manager, PCPs, educators. |
| Participant-reported measures: Self-efficacy for diabetes | 3-months following enrollment | Assessed at 3-month survey |
| Participant-reported measures: Motivation and locus of control | 3-months following enrollment | Assessed at 3-month survey |
| Participant-reported measures: Diabetes distress | 3-months following enrollment | Assessed at 3-month survey |
| Participant-reported measures: Diabetes stigma | 3-months following enrollment | Assessed at 3-month survey |
| Participant-reported measures: Diet and Exercise | 3-months following enrollment | Assessed at 3-month survey |
Countries
United States
Contacts
Primary ContactAmy Valdati
Outcome results
None listed