Navigator Outreach for Medicaid Enrollment

Overseen By Rebecca Myerson, MPH, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Non-English, Non-Spanish, No cell phone

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: Unknown

224000 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely, as the trial focuses on Medicaid enrollment, not medical treatment.

Will I have to stop taking my current medications?

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

What data supports the idea that Navigator Outreach for Medicaid Enrollment is an effective treatment?

The available research shows that patient navigator programs, similar to Navigator Outreach for Medicaid Enrollment, have been effective in other areas. For example, a study on heart failure patients found that using a navigator team reduced the 30-day readmission rate from 25.6% to 17.6%, and even further to 10.3% and 6.1% with specific interventions. This suggests that navigator programs can improve outcomes by providing personalized support and follow-up care. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Outreach From Navigators, Navigator Outreach, Medicaid Navigator Assistance, One-on-One Enrollment Support?

Research shows that patient navigator programs, which include outreach and personalized support, have been effective in reducing hospital readmission rates and improving care quality in various settings, such as heart failure management and breast cancer care. These programs help patients understand their health needs and navigate the healthcare system, suggesting they could also be effective in assisting with Medicaid enrollment. ^{1 2 3 4 5}

What safety data exists for Navigator Outreach for Medicaid Enrollment?

The provided research does not contain specific safety data for Navigator Outreach for Medicaid Enrollment or its related names. The studies focus on adverse drug events and reporting in medical settings, which are unrelated to the safety of Medicaid enrollment assistance programs. ^{6 7 8 9 10}

Is the treatment 'Outreach From Navigators' a promising treatment for Medicaid enrollment?

Yes, 'Outreach From Navigators' is a promising treatment for Medicaid enrollment. It helps people understand and sign up for Medicaid, especially in complex situations. Navigators provide personal support, which is important for reaching vulnerable communities and ensuring more people get the health coverage they need. ^{11 12 13 14 15}

How is the Navigator Outreach treatment different from other treatments for Medicaid enrollment?

Navigator Outreach is unique because it provides personalized, one-on-one support to help individuals enroll in Medicaid, addressing barriers that people face in understanding and accessing health insurance. Unlike other treatments, it involves direct assistance from trained navigators who guide individuals through the enrollment process, making it more accessible and tailored to individual needs. ^{11 12 13 14 15}

What is the purpose of this trial?

This project will assess the impact of various forms of outreach from navigators on Medicaid enrollment. Navigators are professionals who can provide one-on-one assistance with the Medicaid renewal process. The investigators propose to randomize the nature of outreach to households in Wisconsin enrolled in fee-for-service Medicaid who must renew or lose their coverage.

Research Team

Rebecca Myerson, MPH, PhD

Principal Investigator

UW-Madison School of Medicine and Public Health

Eligibility Criteria

This trial is for individuals in Wisconsin who are enrolled in fee-for-service Medicaid and need to renew their coverage. Participants must be on the lists provided by Wisconsin DHS to Covering Wisconsin, understand English or Spanish, and have a cellular phone number.

Inclusion Criteria

Included on the lists Wisconsin DHS provides to Covering Wisconsin of fee-for-service Medicaid beneficiaries who need to renew their Medicaid coverage

Exclusion Criteria

Lack a cellular phone number

I prefer communicating in a language other than English or Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Outreach Intervention

Participants receive various forms of outreach to assist with Medicaid renewal, including text messages, postcards, and outbound calls.

up to 1 year

Follow-up

Participants are monitored for the effectiveness of outreach strategies on Medicaid enrollment and renewal.

up to 1 year

Treatment Details

Interventions

• Outreach From Navigators

Trial Overview The study is testing how different types of outreach from navigators affect Medicaid enrollment rates. Navigators help with one-on-one assistance during the renewal process. People will be randomly assigned to receive various forms of this outreach.

Participant Groups

Group I: Outreach via Text Message Encouraging a Call to a Hotline for Assistance + a Reminder Message Experimental Treatment 1 Intervention

Outreach via text message encouraging a call to a hotline for assistance plus a similar reminder message two weeks later (15% of sample)

Group II: Outreach via Text Message Encouraging Text Reply To Connect with Navigators+ a Reminder Message Experimental Treatment 1 Intervention

Outreach via text message encouraging a text reply to connect with navigators via chatbot plus a similar reminder message two weeks later (15% of sample)

Group III: Outreach via Text Message Encouraging Text Reply To Connect with Navigators + Outbound Call Experimental Treatment 1 Intervention

Outreach via text message encouraging a text reply to connect with navigators via chatbot, plus an outbound phone call from navigators (7.5% of sample)

Group IV: Outreach via Text Message Encouraging Text Reply To Connect with Navigators Experimental Treatment 1 Intervention

Outreach via text message encouraging a text reply to connect with navigators via chatbot (15% of sample)

Group V: Outreach via Text Message Encouraging Reply To Connect with Navigators + Reminder Message Experimental Treatment 1 Intervention

Outreach via text message encouraging a text reply to connect with navigators via chatbot plus a similar reminder message two weeks later + outbound call (7.5% of sample)

Group VI: Outreach via Text Message Encouraging Call to Hotline + Outbound Call Experimental Treatment 1 Intervention

Outreach via text message encouraging a call to a hotline for assistance, plus outbound phone call from navigators (7.5% of sample)

Group VII: Outreach via Text Message Encouraging Call to Hotline Experimental Treatment 1 Intervention

Outreach via text message encouraging a call to a hotline for assistance (15% of sample)

Group VIII: Outreach via Postcard + Outbound Call Experimental Treatment 1 Intervention

Outreach via postcard, plus placed an outbound phone call from navigators (20% of sample)

Group IX: Outreach via Postcard Experimental Treatment 1 Intervention

40 percent of the sample

Group X: Outreach Text Message Encouraging Call a Hotline for Assistance + Reminder Message Experimental Treatment 1 Intervention

Outreach via text message encouraging a call to a hotline for assistance plus a similar reminder message two weeks later + outbound call (7.5% of sample)

Outreach From Navigators is already approved in United States for the following indications:

Approved in United States as Navigator Outreach for:

• Medicaid Enrollment Assistance
• Health Insurance Navigation

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Covering Wisconsin

Collaborator

Trials

3

Recruited

649,000+

Findings from Research

The implementation of a patient navigator program at a public hospital significantly improved adherence to breast cancer quality care indicators from 69% to 86% among 100 newly diagnosed patients (Stages I to III).

The program particularly enhanced the use of surveillance mammography, increasing adherence from 52% to 76%, demonstrating that patient navigators can effectively address barriers to care in uninsured populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving breast cancer quality of care with the use of patient navigators. Chen, F., Mercado, C., Yermilov, I., et al.[2010]

The implementation of the Patient Navigator Program for hospitalized heart failure patients led to a significant reduction in the 30-day all-cause readmission rate, dropping from 25.6% at the medical center to 17.6% with the program.

Patients who received targeted interventions from the Navigator Team, such as education and follow-up, experienced even lower readmission rates of 10.3% and 6.1%, respectively, highlighting the effectiveness of personalized care in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Patient Navigator Program to Reduce 30-day Heart Failure Readmission Rate. Di Palo, KE., Patel, K., Assafin, M., et al.[2018]

Patient navigation programs have shown a low refusal rate (4%-6%) for clinical trial participation among medically underserved populations, indicating potential effectiveness in reducing barriers to enrollment.

However, there is a need for more research to evaluate the overall efficacy of these programs in increasing clinical trial enrollment, as few studies have reported on this outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual. Ghebre, RG., Jones, LA., Wenzel, JA., et al.[2023]

The use of patient navigators (PNs) significantly reduced healthcare costs for high-risk patients aged 60 and older, with total costs dropping from $7,640 to $5,676 within 180 days post-discharge.

While the PN intervention showed cost savings for older patients, it did not significantly impact costs for those under 60, suggesting that PNs may be particularly beneficial for older adults in transitional care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Impact of a Postdischarge Community Health Worker Intervention on Health Care Costs in a Safety-Net System. Galbraith, AA., Meyers, DJ., Ross-Degnan, D., et al.[2019]

A successful patient navigation program for American Indian populations in the Northern and Southern Plains increased community knowledge about cancer and improved cancer screening behaviors through 24-hour workshops.

Collaboration with trusted Native Patient Navigators helped bridge the gap between patients and healthcare providers, enhancing adherence to care recommendations and ultimately improving quality of life and survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigation as an intervention to eliminate disparities in American Indian communities. Krebs, LU., Burhansstipanov, L., Watanabe-Galloway, S., et al.[2021]

A pharmacist-led program effectively managed adverse events in 123 patients with EGFR mutation-positive non-small cell lung cancer receiving afatinib, highlighting the importance of patient education and proactive monitoring in a community oncology setting.

Common adverse events included diarrhea (85%) and rash/skin reactions (58%), with 13% of patients discontinuing treatment due to these side effects; however, those who continued treatment often had dose reductions, indicating a strategy to maintain therapy despite adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist-led patient education and adverse event management in patients with non-small cell lung cancer receiving afatinib in a community-based, real-world clinical setting. Khrystolubova, N., Shieh, M., Patel, AJ., et al.[2020]

Adverse drug events (ADEs) contribute to 1.7-11% of hospital admissions and occur in 1-44% of hospitalized patients, yet less than 10% of these events are reported to national agencies, highlighting a significant gap in safety reporting.

While 75% of nursing schools promote awareness of ADE reporting, only about half provide training on how and what to report, indicating a need for improved education and support for advanced practice nurses to enhance public safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug event reporting and advanced-nursing practice. Meints, AS.[2019]

In 2013-2014, there were an estimated 4.0 emergency department visits per 1000 individuals annually for adverse drug events in the U.S., with 27.3% of these visits resulting in hospitalization, highlighting the significant impact of medication-related issues on patient safety.

Anticoagulants, antibiotics, and diabetes agents accounted for nearly half (46.9%) of these adverse drug events, with older adults (aged 65 and older) experiencing the highest hospitalization rates, indicating a need for careful medication management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014. Shehab, N., Lovegrove, MC., Geller, AI., et al.[2022]

In a study of 696 patients across 7 intensive care units, 15.5% experienced adverse drug events (ADEs), with a significant portion (70%) of these being nonpreventable adverse drug reactions (ADRs).

The research highlighted that most preventable ADEs stemmed from medication errors during the prescribing stage (71.1%), indicating a critical need for improved pharmacovigilance and error reporting practices to enhance drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of adverse drug events and medication errors in intensive care units: a prospective multicenter study. Benkirane, RR., Abouqal, R., Haimeur, CC., et al.[2022]

A study of 377 Texas pharmacists revealed that 67.9% had never reported adverse drug events (ADEs) to the FDA, indicating a significant gap in reporting practices.

Most pharmacists (65.7%) felt they lacked adequate knowledge about ADE reporting, highlighting the need for improved education and training on how to report ADEs effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Texas pharmacists' knowledge of reporting serious adverse drug events to the Food and Drug Administration. Gavaza, P., Brown, CM., Lawson, KA., et al.[2015]

The creation of a student-led Medicaid Enrollment Team at the HOPES free clinic aimed to help citizens overcome barriers to enrolling in Medicaid after its expansion in Virginia.

The paper outlines effective steps taken by this program that can serve as a model for future Medicaid enrollment efforts, emphasizing the importance of comprehensive assistance in improving access to healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Sustainable Model for Medicaid Enrollment at the HOPES Free Clinic. Taylor-Fishwick, JS., Patel, P., Van de Graaf, M., et al.[2021]

Navigators in the federal Insurance Navigator Program play a crucial role in promoting health equity by providing essential services and support to underserved communities, going beyond their basic responsibilities.

The study highlights that navigators develop their equity skills through on-the-job experience, but face significant challenges due to financial instabilities, which hinder their ability to effectively assist those in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of Consistent Investment in Federal Insurance Navigator Program Undermines Navigators' Equity Work in Vulnerable Communities. van Eijk, MS., Kett, PM., Prueher, L., et al.[2023]

Enrollment navigators and Medicaid workers were crucial for the initial success of the Affordable Care Act (ACA), but significant funding cuts (41% for navigators and 90% for outreach) threaten ongoing enrollment efforts.

Focus group discussions with 101 enrollment workers in California revealed a strong need for better communication and collaboration among workers and policymakers to address barriers and improve enrollment strategies, especially for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Medicaid Access in Times of Health Policy Change: Solutions from Focus Groups with Frontline Enrollment Workers. Raymond-Flesch, M., Lucia, L., Jacobs, K., et al.[2019]

Iowa's Medicaid expansion included a personal responsibility component, but early evaluations showed low compliance and awareness among enrollees, highlighting a gap in understanding the program.

Interviews with outreach staff at Federally Qualified Health Centers (FQHCs) revealed that these centers employ various strategies to help individuals enroll in Medicaid and navigate their health insurance, indicating a crucial support role as Medicaid programs become more complex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating a Complicated Medicaid Waiver Program to Enrollees in Iowa: How Federally Qualified Health Centers Support Medicaid Members. Askelson, NM., Brady, PJ., Wright, B., et al.[2021]

The Affordable Care Act (ACA) significantly increased access to health insurance, particularly through Medicaid expansion and health insurance marketplaces, with various outreach strategies employed by states during the first enrollment season.

Local health departments (LHDs) are underutilized resources in ACA outreach and enrollment efforts, and case studies, including one from West Virginia, highlight innovative models and best practices for LHD involvement to enhance community engagement and enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Role of State and Local Public Health in Outreach and Enrollment for Expanded Coverage: A Case Study on West Virginia. Elligers, JJ., Bharmal, N., Martin, LT., et al.[2020]

References

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

Improving breast cancer quality of care with the use of patient navigators. [2010]

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

Implementation of a Patient Navigator Program to Reduce 30-day Heart Failure Readmission Rate. [2018]

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

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual. [2023]

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

Long-Term Impact of a Postdischarge Community Health Worker Intervention on Health Care Costs in a Safety-Net System. [2019]

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

Navigation as an intervention to eliminate disparities in American Indian communities. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacist-led patient education and adverse event management in patients with non-small cell lung cancer receiving afatinib in a community-based, real-world clinical setting. [2020]

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

Adverse drug event reporting and advanced-nursing practice. [2019]

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

US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014. [2022]

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

Incidence of adverse drug events and medication errors in intensive care units: a prospective multicenter study. [2022]

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

Texas pharmacists' knowledge of reporting serious adverse drug events to the Food and Drug Administration. [2015]

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

Developing a Sustainable Model for Medicaid Enrollment at the HOPES Free Clinic. [2021]

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

Lack of Consistent Investment in Federal Insurance Navigator Program Undermines Navigators' Equity Work in Vulnerable Communities. [2023]

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

Improving Medicaid Access in Times of Health Policy Change: Solutions from Focus Groups with Frontline Enrollment Workers. [2019]

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

Communicating a Complicated Medicaid Waiver Program to Enrollees in Iowa: How Federally Qualified Health Centers Support Medicaid Members. [2021]

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

Assessing the Role of State and Local Public Health in Outreach and Enrollment for Expanded Coverage: A Case Study on West Virginia. [2020]