RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06481319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 43 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * A new patient at BMC Reproductive Endocrinology for the diagnosis of infertility from July 1, 2024 to January 31, 2025 Controls
  2. * A new patient at BMC Reproductive Endocrinology for the diagnosis of infertility from July 1, 2023 to January 31, 2024.
  1. * Patients in whom fertility treatment with their own eggs is not recommended, egg freezing or oncofertility cycles.
  2. * Non-English speaking

Contacts and Locations

Study Contact

Wendy Kuohung, MD
CONTACT
617-414-5175
wkuohung@bu.edu
Nora Khalil, BS
CONTACT
617-414-5175
nokhalil@bu.edu

Principal Investigator

Wendy Kuohung, MD
PRINCIPAL_INVESTIGATOR
Boston Medical Center

Study Locations (Sites)

Boston Medical Center, Reproductive Endocrinology
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston Medical Center

  • Wendy Kuohung, MD, PRINCIPAL_INVESTIGATOR, Boston Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-01
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Infertility Patient Navigator (PN)
  • Under-resourced patients
  • Cycle based testing
  • Urology appointments
  • Health Literacy
  • Boston Medical Center

Additional Relevant MeSH Terms

  • Infertility