Care Navigator Support for Type 2 Diabetes

(AURORA Trial)

Overseen By Amy Valdati

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Pregnancy, Type 1 diabetes

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 months

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Care Navigator Support for Type 2 Diabetes safe for humans?

The research does not provide specific safety data for the Care Navigator Support for Type 2 Diabetes or its related programs like AURORA Care Strategy. However, similar navigator programs have been used in healthcare settings to improve patient outcomes, suggesting they are generally considered safe. ^{1 2 3 4 5}

What makes the AURORA Care Strategy treatment unique for managing Type 2 Diabetes?

The AURORA Care Strategy is unique because it uses patient navigators to provide culturally sensitive support and education, helping younger Latinx patients overcome barriers to healthcare access and improve diabetes management, which is not typically a focus of standard diabetes treatments. ^{4 6 7 8 9}

What data supports the effectiveness of the AURORA Care Strategy treatment for Type 2 Diabetes?

Research shows that culturally tailored diabetes self-management education, which includes coaching and navigator programs, is effective in improving diabetes knowledge and health outcomes among Latinos. Additionally, using health information technology tools and patient navigators can help reduce healthcare disparities in this population. ^{4 5 9 10 11}

Who Is on the Research Team?

Anjali Gopalan, MD, MS

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for younger Latinx adults aged between 20 and 45 who are members of Kaiser Permanente Northern California, have been newly diagnosed with Type 2 Diabetes in the last 1-8 months, and have an HbA1c level of at least 8%. They must be proficient in English or Spanish. Pregnant women and individuals with Type 1 Diabetes cannot participate.

Inclusion Criteria

I am between 21 and 44 years old, recently diagnosed with Type 2 Diabetes, and my HbA1c is at least 8%.

I can communicate well in English or Spanish.

Exclusion Criteria

Pregnant women

I have Type 1 Diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AURORA Care Strategy, including three telemedicine visits tailored to Latinx adults with early onset type 2 diabetes

3 months

3 visits (telemedicine)

Follow-up

Participants are monitored for changes in HbA1c and other diabetes-related outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• AURORA Care Strategy

Trial Overview The AURORA Care Strategy is being tested to see if a culturally responsive care navigator can help young Latinx adults manage their new diagnosis of Type 2 Diabetes more effectively within the healthcare system provided by Kaiser Permanente Northern California.

How Is the Trial Designed?

Group I: AURORA Care Strategy Experimental Treatment 1 Intervention

Participants will receive the AURORA Care Strategy in addition to their usual diabetes care.

Group II: Usual Care Active Control 1 Intervention

No intervention will be employed. This arm will continue to receive their usual diabetes care.

AURORA Care Strategy is already approved in United States for the following indications:

Approved in United States as AURORA Care Strategy for:

• Type 2 Diabetes management in younger-onset Latinx individuals

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Published Research Related to This Trial

A 27-week automated telephone self-management support program for diabetes significantly improved self-care behaviors and physical health scores among linguistically diverse patients, with effect sizes of 0.29 and 0.25 respectively.

The intervention was effective for English, Spanish, and Cantonese speakers, suggesting that automated telephone support can enhance diabetes management in low-income populations, although it did not significantly impact patient-centered care processes or cardiometabolic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes health information technology innovation to improve quality of life for health plan members in urban safety net. Ratanawongsa, N., Handley, MA., Sarkar, U., et al.[2022]

Culturally tailored diabetes self-management education (DSME) effectively improves glycemic control and health outcomes in Mexican Americans, as shown in a study with 165 participants in a rural Texas community.

Adding a nurse case manager (NCM) to the DSME program increased attendance rates, although both groups showed similar improvements in diet, physical activity, and clinical outcomes, indicating the need for further research on the NCM's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating education, group support, and case management for diabetic Hispanics. Brown, SA., García, AA., Winter, M., et al.[2021]

Implementing volunteer bilingual navigation in a children's multispecialty clinic led to a non-significant decrease in appointment no-shows, suggesting it may help improve attendance for monolingual Spanish-speaking families.

Patient satisfaction ratings increased from 84.0 to 92.9 during the intervention, indicating that bilingual navigation could enhance the overall experience for Spanish-speaking families, even though the increase was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Satisfaction and Appointment Attendance Through Navigation for Spanish-Speaking Families. Flower, KB., Wurzelmann, S., Rojas, C., et al.[2021]

Latinos experience higher rates of diabetes and related complications, and existing health information technology (HIT) tools for diabetes management may not be effectively utilized by this group, especially those with low literacy or limited English proficiency.

The development of a novel 'eNavigator' role aims to enhance the adoption of HIT among Latinos, which could help improve diabetes self-management and reduce health care disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closing the gap: eliminating health care disparities among Latinos with diabetes using health information technology tools and patient navigators. López, L., Grant, RW.[2022]

In a study of 27,542 patients with diabetes, Hispanic patients were found to have higher HbA1c levels compared to other racial/ethnic groups, indicating poorer diabetes control.

While medication adherence (measured by the proportion of days covered) was negatively associated with HbA1c levels, the disparity in HbA1c levels among Hispanic patients persisted, suggesting that other factors beyond medication adherence may contribute to these differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Relationship Between Medication Adherence and Diabetes Disparities among Hispanic Patients in a Large Health System. Narain, KDC., Patel, A., Skootsky, S., et al.[2023]

Limited English proficiency (LEP) among US Latinos with diabetes is linked to poorer glycemic control, particularly when patients have language-discordant physicians, as shown in a study of 3,688 patients.

LEP Latinos with language-concordant physicians had similar odds of poor glycemic control as English-speaking Latinos, suggesting that improving language concordance in healthcare could help reduce health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Language barriers, physician-patient language concordance, and glycemic control among insured Latinos with diabetes: the Diabetes Study of Northern California (DISTANCE). Fernandez, A., Schillinger, D., Warton, EM., et al.[2022]

Adverse drug events (ADEs) are a major cause of preventable harm in hospitals, particularly affecting older adults, prompting the creation of a National Action Plan to enhance medication safety.

The Action Plan focuses on preventing ADEs from three high-risk medication classes: anticoagulants, diabetes agents, and opioids, and emphasizes surveillance, evidence-based prevention, and education for both healthcare providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Medication Safety: Establishing a National Action Plan for Adverse Drug Event Prevention. Harris, Y., Hu, DJ., Lee, C., et al.[2019]

A culturally tailored, integrated care intervention for low-income, Spanish-speaking Latinos with type 2 diabetes significantly improved HbA1c levels over 6 months, showing a greater reduction compared to usual care (ΔHbA1c = -0.35 vs. ΔHbA1c = -0.02).

The intervention also led to improvements in total cholesterol and diastolic blood pressure, indicating that this model of care can effectively support diabetes management and self-care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos with diabetes. Talavera, GA., Castañeda, SF., Mendoza, PM., et al.[2022]

The Patient Navigator Program at NewYork-Presbyterian Queens successfully supported 30,164 patients from February 2020 to December 2022, significantly improving follow-up appointment attendance, with 81% of patients attending their scheduled appointments.

The program demonstrated that Patient Navigators, who provide culturally sensitive education and support, can effectively help patients without primary care providers establish new care connections, as 94% of these patients secured a new provider upon discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency department patient navigators successfully connect patients to care within a rapidly evolving healthcare system. Peretz, PJ., Vargas, H., D'urso, M., et al.[2023]

The DIALBEST trial demonstrated that a community health worker (CHW)-led intervention significantly improved glycemic control in 211 Latino adults with poorly controlled type 2 diabetes (T2D), with notable reductions in HbA1c levels over 18 months.

Participants receiving the CHW intervention showed consistent improvements in HbA1c at multiple time points (3, 6, 12, and 18 months), indicating the effectiveness of structured support in managing diabetes, although there were no significant changes in blood lipid levels, hypertension, or weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a community health workers-led structured program on blood glucose control among latinos with type 2 diabetes: the DIALBEST trial. Pérez-Escamilla, R., Damio, G., Chhabra, J., et al.[2022]

A systematic review of 12 quantitative studies identified key barriers to healthcare access for Hispanics with type 2 diabetes, including self-care behaviors, individual resources like cost, and a lack of specialized providers.

The majority of barriers were self-related (92%), indicating that personal factors such as diet and exercise significantly impact access to care, while provider-related (50%) and environmental factors (25%) also play a role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Barriers to Access-to-Care in Hispanics With Type 2 Diabetes. Titus, SK., Kataoka-Yahiro, M.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Diabetes health information technology innovation to improve quality of life for health plan members in urban safety net. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Integrating education, group support, and case management for diabetic Hispanics. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Improving Satisfaction and Appointment Attendance Through Navigation for Spanish-Speaking Families. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Closing the gap: eliminating health care disparities among Latinos with diabetes using health information technology tools and patient navigators. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Exploring the Relationship Between Medication Adherence and Diabetes Disparities among Hispanic Patients in a Large Health System. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Language barriers, physician-patient language concordance, and glycemic control among insured Latinos with diabetes: the Diabetes Study of Northern California (DISTANCE). [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Advancing Medication Safety: Establishing a National Action Plan for Adverse Drug Event Prevention. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos with diabetes. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Emergency department patient navigators successfully connect patients to care within a rapidly evolving healthcare system. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Impact of a community health workers-led structured program on blood glucose control among latinos with type 2 diabetes: the DIALBEST trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Barriers to Access-to-Care in Hispanics With Type 2 Diabetes. [2021]