Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients
NCT Number: NCT06481319
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infertility
Interventions: BEHAVIORAL: Infertility Patient Navigator
Sponsor: Boston Medical Center
Sex: FEMALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2026-03
Locations: Boston Medical Center, Reproductive Endocrinology, Boston, Massachusetts, 02118, United States

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.

Primary Outcome Measures: Time to complete infertility evaluation, This outcome will be assessed by data abstracted from the electronic medical record (EMR)., 12 months|Time to start fertility treatments, This outcome will be assessed by data abstracted from the EMR., 12 months|Wait time for urology appointments, This outcome will be assessed by data abstracted from the EMR., 12 months|Wait time for weight management appointments, This outcome will be assessed by data abstracted from the electronic medical record., 12 months
Secondary Outcome Measures: Pregnancy rate, This outcome will be assessed by data abstracted from the EMR by dividing the number of pregnancies by the number of participants., 12 months|Time to live birth, This outcome will be assessed by data abstracted from the EMR., 12 months|Frequency of PN contacts in Intervention Group, This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group, 12 months|Number of PN contacts in Intervention Group, This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group, 12 months|Duration of PN contacts in Intervention Group, This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group, 12 months