Navigating Health Insurance Selection for IVF Benefits

Navigating Health Insurance Selection for in Vitro Fertilization (IVF) Benefits

The purpose of this study is to evaluate the effectiveness of an educational intervention on health insurance literacy and utilization of in vitro fertilization (IVF) insurance benefits. The investigators hypothesize that the intervention is acceptable and satisfactory and will result in increased health insurance literacy and utilization of IVF benefits.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Behavioral: Health insurance educational guide

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Employees eligible for health insurance coverage
• Reproductive aged (18 to 50 years)
• Intention to grow their family in the next year
• Primary language English or Spanish

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health insurance educational guide; Eligible individuals will receive a health insurance educational guide to support choosing among 5 health plans for IVF coverage. They will also receive receive a one-page guide with a link to the Open Enrollment website that is available to all employees during the open enrollment period.	Behavioral: Health insurance educational guide; The educational guide includes 4 content areas: 1) Definition of key insurance terms; 2) premiums, deductibles across the five 2023 health plans; 3) Summary of how premiums and deductibles can affect out of pocket costs; 4) Guide to finding in-network IVF providers and facilities.
No Intervention: Usual care; Eligible individuals will receive a one-page guide with a link to the Open Enrollment website that is available to all employees during the open enrollment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Insurance Literacy Measure	9 items from the Health Insurance Literacy Measure will assess participants' confidence using their health insurance and being proactive with their health insurance for IVF services. Items will be scored from 0 (not at all confident) to 3 (very confident). Higher scores indicate better health insurance literacy.	10 months after receipt of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Insurance Literacy Measure	6 items from the Health Insurance Literacy Measure will assess participants' likelihood of comparing health insurance plans. Items will be scored from 0 (not at all confident) to 3 (very confident). Higher scores indicate better health insurance literacy.	1 month after receipt of the intervention
Utilization of IVF services	Participants will self-report utilization of IVF services.	10 months after receipt of the intervention
Insurance coverage	Participants will self-report insurance coverage related to IVF services.	10 months after receipt of the intervention
Out of pocket expenses	Participants will self-report out-of-pocket expenses related to IVF services.	10 months after receipt of the intervention
Financial hardship	The 15-item Economic Strain and Resilience in Cancer tool will be used as a self-report subjective measure of financial hardship related to infertility and IVF services. Items are scored from 0 (least hardship) to 10 (most severe hardship). Higher scores indicate worse financial hardship.	10 months after receipt of the intervention

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: H. Irene Su, MD MSCE, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: IVF; infertility; health insurance
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 805955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.
• IPD Sharing Time Frame: Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
• IPD Sharing Access Criteria: Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to the principal investigator (H. Irene Su).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No