Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients

NCT ID: NCT06481319

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-06
• Study Completion Date: 2026-03-31

Brief Summary

This investigators will conduct a pilot study investigating the implementation of an infertility Patient Navigator (PN) program to mitigate challenges for underserved individuals at Boston Medical Center (BMC) seeking infertility care. The primary objective is to assess whether the PN program can significantly reduce time to completion of infertility evaluation and to initiation of fertility treatment (if recommended) for infertile patients from an underserved patient population.

The study aims are to:

1. evaluate the impact of the PN program on timelines including obtaining commercial insurance coverage for infertility, expediting labwork/imaging, weight management, and partner urology appointments, and initiating fertility treatment; and

2. ascertain the medical literacy of participants with a validated tool to assess the impact of low medical literacy on PN facilitation.

Participants will be contacted by the PN and provided with a survey instrument that will test their medical literacy. Then the PN will assist with scheduling cycle-based testing including labwork and uterine cavity evaluation, the partner's urology appointment, the patient's appointments such weight management/nutrition referral, mammograms (if indicated by age), and insurance counseling if the participant's current insurance does not cover infertility diagnostic testing and treatment. These tasks are part of pursuing fertility care at BMC.

Duration of evaluation and time to treatment in age-matched control patients from the year prior that did not have PN services will be utilized as a comparison group.

Regression analyses will be conducted to explore the association between utilization of a PN and pregnancy rates, considering potential confounding factors.

Establishment of the pilot program will enable the investigators to apply for a larger institutional patient care grant going forward. Strategies developed through this research can may enhance fertility care access for underserved communities across various healthcare settings. By tailoring interventions to populations not usually able to access specialized healthcare services, this study pioneers a paradigm shift towards inclusivity and equity in reproductive medicine.

Conditions

Infertility

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Infertility Patient Navigator Group

Participants in this group will receive assistance from the Infertility Patient Navigator (PN) to schedule and complete the infertility evaluation.

Group Type: EXPERIMENTAL

Infertility Patient Navigator

Intervention Type: BEHAVIORAL

Assistance with infertility evaluation including scheduling appointments

Historical Comparison Group

Age-matched controls selected from the electronic medical record database who received infertility evaluation without PN assistance.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Infertility Patient Navigator

Assistance with infertility evaluation including scheduling appointments

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Intervention cases

• A new patient at BMC Reproductive Endocrinology for the diagnosis of infertility from July 1, 2024 to January 31, 2025 Controls
• A new patient at BMC Reproductive Endocrinology for the diagnosis of infertility from July 1, 2023 to January 31, 2024.

Exclusion Criteria

• Patients in whom fertility treatment with their own eggs is not recommended, egg freezing or oncofertility cycles.
• Non-English speaking

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy Kuohung, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center, Reproductive Endocrinology

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Wendy Kuohung, MD

Role: CONTACT

wkuohung@bu.edu

617-414-5175

Nora Khalil, BS

Role: CONTACT

nokhalil@bu.edu

617-414-5175

Facility Contacts

Wendy Kuohung, MD

Role: primary

wkuohung@bu.edu

Other Identifiers

H-44747

Identifier Type: -

Identifier Source: org_study_id