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Navigating Health Insurance Selection for IVF Benefits

Primary Purpose

Infertility

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health insurance educational guide
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility focused on measuring infertility, IVF, health insurance

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health insurance educational guide

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Utilization of IVF services
Participants will self-report utilization of IVF services.
Insurance coverage
Participants will self-report insurance coverage related to IVF services.
Out of pocket expenses
Participants will self-report out-of-pocket expenses related to IVF services.
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.

Full Information

First Posted
December 1, 2022
Last Updated
December 21, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05663645
Brief Title
Navigating Health Insurance Selection for IVF Benefits
Official Title
Navigating Health Insurance Selection for in Vitro Fertilization (IVF) Benefits
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility, IVF, health insurance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health insurance educational guide
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health insurance educational guide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health Insurance Literacy Measure
Description
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.
Time Frame
10 months after receipt of the intervention
Secondary Outcome Measure Information:
Title
Health Insurance Literacy Measure
Description
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.
Time Frame
1 month after receipt of the intervention
Title
Utilization of IVF services
Description
Participants will self-report utilization of IVF services.
Time Frame
10 months after receipt of the intervention
Title
Insurance coverage
Description
Participants will self-report insurance coverage related to IVF services.
Time Frame
10 months after receipt of the intervention
Title
Out of pocket expenses
Description
Participants will self-report out-of-pocket expenses related to IVF services.
Time Frame
10 months after receipt of the intervention
Title
Financial hardship
Description
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.
Time Frame
10 months after receipt of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Irene Su, MD MSCE
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

Navigating Health Insurance Selection for IVF Benefits

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