Navigating Health Insurance Selection for IVF Benefits
1 other identifier
interventional
221
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2022
CompletedFirst Submitted
Initial submission to the registry
December 1, 2022
CompletedFirst Posted
Study publicly available on registry
December 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 30, 2024
October 1, 2024
1.1 years
December 1, 2022
October 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Health Insurance Literacy Measure
1 month after receipt of the intervention
Utilization of IVF services
10 months after receipt of the intervention
Insurance coverage
10 months after receipt of the intervention
Out of pocket expenses
10 months after receipt of the intervention
Financial hardship
10 months after receipt of the intervention
Study Arms (2)
Health insurance educational guide
EXPERIMENTALEligible 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.
Usual care
NO INTERVENTIONEligible 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Diego
La Jolla, California, 92093, United States
Related Publications (1)
Dayo O, Turcotte V, Reyes B, Flores Ortega RE, Kaiser BN, Aarons GA, McMenamin SB, Su HI, Romero SAD. Navigating health insurance selection for in vitro fertilization (IVF) benefits: A study protocol. Contemp Clin Trials. 2025 Aug;155:107998. doi: 10.1016/j.cct.2025.107998. Epub 2025 Jun 30.
PMID: 40602660DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
H. Irene Su, MD MSCE
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 1, 2022
First Posted
December 23, 2022
Study Start
November 9, 2022
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
October 30, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
- 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).
Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.