Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients
- Conditions
- Infertility
- Interventions
- Behavioral: Infertility Patient Navigator
- Registration Number
- NCT06481319
- Lead Sponsor
- Boston Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 40
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.
- Patients in whom fertility treatment with their own eggs is not recommended, egg freezing or oncofertility cycles.
- Non-English speaking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Infertility Patient Navigator Group Infertility Patient Navigator Participants in this group will receive assistance from the Infertility Patient Navigator (PN) to schedule and complete the infertility evaluation.
- Primary Outcome Measures
Name Time Method Time to start fertility treatments 12 months This outcome will be assessed by data abstracted from the EMR.
Wait time for urology appointments 12 months This outcome will be assessed by data abstracted from the EMR.
Wait time for weight management appointments 12 months This outcome will be assessed by data abstracted from the electronic medical record.
Time to complete infertility evaluation 12 months This outcome will be assessed by data abstracted from the electronic medical record (EMR).
- Secondary Outcome Measures
Name Time Method Time to live birth 12 months This outcome will be assessed by data abstracted from the EMR.
Number of PN contacts in Intervention Group 12 months This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group
Pregnancy rate 12 months This outcome will be assessed by data abstracted from the EMR by dividing the number of pregnancies by the number of participants.
Frequency of PN contacts in Intervention Group 12 months This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group
Duration of PN contacts in Intervention Group 12 months This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group
Trial Locations
- Locations (1)
Boston Medical Center, Reproductive Endocrinology
🇺🇸Boston, Massachusetts, United States