Virtual Health Insurance Navigation Pilot Program for Childhood Survivors (HINTII)

Childhood Cancer Survivors Clinical Trial

— HINTII  

Official title:

Assessing the Effect of Virtual Navigation Interventions to Improve Health Insurance Literacy and Decrease Financial Burden: A Childhood Cancer Survivor Study Randomized Trial (HINTII)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527392
• Other study ID #: 2022P000176
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: April 1, 2027

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: Elyse R Park, PhD
• Phone: 617-724-6836
• Email: epark[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are conducting a Type I hybrid effectiveness-implementation trial to assess the effectiveness of HINT-S (synchronous) compared to enhanced usual care (EUC) in promoting health insurance literacy, thus reducing worry, unmet health care needs, and financial consequences due to medical costs to improve care and long-term outcomes of childhood cancer survivors. The investigators will also compare HINT-S to HINT-A (asynchronous), a prerecorded, asynchronous version of the 5 HINT-S navigator sessions.

Description:

The present study seeks to evaluate a health insurance navigation program with childhood cancer survivors recruited from the Long-Term Follow-Up (LTFU) Cohort. Childhood cancer survivors face health challenges throughout their lives that require monitoring and ongoing care. This is compounded by the tendency among childhood survivors to have higher rates of underinsurance, unmet healthcare needs, and burdensome costs related to care. These burdensome costs also contribute to underutilization of care among survivors. Dr. Park and her colleagues published findings that suggested LTFU survivors had difficulty in understanding how to use their insurance, and often experienced financial-related distress. Understanding and navigating insurance benefits in the current landscape is crucial for cancer survivors to obtain and utilize the health care that they need. With this in mind, the study investigators propose to evaluate the effectiveness of an insurance navigation intervention with LTFU participants, delivered in a synchronous and asynchronous modality.

The navigation intervention will be delivered by a health insurance navigator via HIPAA-compliant videoconferencing for the synchronous group (HINT-S) and will be delivered via pre-recorded video session for the asynchronous group HINT-A). Participants will be randomized into either the two navigation intervention arms (HINT-S and HINT-A; approximately 234 per intervention arm), or the enhanced usual care arm (approximately 52 for control arm). The sample size per arm was chosen to enable evaluation of feasibility and acceptability goals, as well as to explore meaningful differences in the outcomes. To assess the proposed primary and secondary outcomes, all trial participants will complete a baseline and 6-month and 12-month post-program follow-up survey.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• are 18 years or older at time of enrollment

• are able to give informed consent

• have access to a smartphone, computer, or tablet with internet access

• have US based health insurance

• current LTFU cohort participants

• having access to the CCSS patient portal.

Exclusion Criteria:

• Participants from the pilot trial will not be eligible

Related Conditions & MeSH terms

• Childhood Cancer Survivors

Intervention

Behavioral:
• Health Insurance Navigation Tools Program
The program will be delivered via videoconferencing by a navigator over approximately a 3-month period and will consist of 5 sessions. The navigation intervention sessions will be as follows: Section 1- Insurance Plan Basics; Section 2- Your Plan in Relation to Policy; Section 3- Navigating Your Plan and Overcoming Obstacles; Section 4- Managing Care Costs; 5-Understanding Your Medical Bills.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

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* Note: There are 117 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Health Insurance Literacy from baseline to 6 months.	Change in Health Insurance Literacy, measured with the validated survey (Health Insurance Literacy scale; HIL), will be compared between groups. The HIL is a 16-item measure of participants' self-reported confidence in understanding of terms (e.g., deductible, co-payments, co-insurance) and confidence in knowing how to do health insurance-related activity (e.g. figuring out co-payments, finding an in-network doctor). Items are rated on a 4-point Likert scale with a total scale score ranging from 16-64; higher scores denote lower literacy.	6 months follow up
Secondary	Change in Health Insurance Literacy from baseline to 12 months.	Change in Health Insurance Literacy, measured with the validated survey (Health Insurance Literacy scale; HIL), will be compared over time between groups. The HIL is a 16-item measure of participants' self-reported confidence in understanding of terms (e.g., deductible, co-payments, co-insurance) and confidence in knowing how to do health insurance-related activity (e.g. figuring out co-payments, finding an in-network doctor). Items are rated on a 4-point Likert scale with a total scale score ranging from 16-64; higher scores denote lower literacy.	12 months follow up
Secondary	Change in self-reported financial hardship from baseline to 12 months.	Change in self-reported financial hardship across time will be compared between groups and measured using 3 scales that tap into 3 domains of financial hardship: a) Behavioral, which assesses unmet health care needs due to health care costs in the past year with 8 yes/no items; more yes scores = more hardship; b) Psychological, which assess worry due to health care costs in the past year with 6-items measured on a 5 point likert; higher score reflects greater worry; c) Material, which assesses the financial consequences of health care cost in the past year with 8 yes/no items; more yes scores = more hardship.	12 months follow up
Secondary	Change in annual out-of-pocket costs from baseline to 12 months.	Change in the dollar amount of out-of-pocket annual costs will be compared over time between groups.	12 months follow up
Secondary	Change in the number of Health Care Visits and Procedures (health care utilization) from baseline to 12 months.	Change in patients healthcare utilization across time will be compared over time between groups.; Health care utilization will be assessed with 11 items which ask patients to report yes/no to health care visits (e.g., any primary care visits in the past year, usual place of care, receipt of annual vaccinations. A greater number of Yes responses reflects more healthcare use.	12 months follow up