Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06481319
Enrollment
28
Registered
2024-07-01
Start date
2025-02-06
Completion date
2026-07-14
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Infertility Patient Navigator (PN), Under-resourced patients, Cycle based testing, Urology appointments, Health Literacy, 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.

Interventions

BEHAVIORALInfertility Patient Navigator

Assistance with infertility evaluation including scheduling appointments

Sponsors

Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

One group intervention with age-matched historical controls

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to complete infertility evaluation12 monthsThis outcome will be assessed by data abstracted from the electronic medical record (EMR).
Time to start fertility treatments12 monthsThis outcome will be assessed by data abstracted from the EMR.
Wait time for urology appointments12 monthsThis outcome will be assessed by data abstracted from the EMR.
Wait time for weight management appointments12 monthsThis outcome will be assessed by data abstracted from the electronic medical record.

Secondary

MeasureTime frameDescription
Pregnancy rate12 monthsThis outcome will be assessed by data abstracted from the EMR by dividing the number of pregnancies by the number of participants.
Time to live birth12 monthsThis outcome will be assessed by data abstracted from the EMR.
Frequency of PN contacts in Intervention Group12 monthsThis outcome will be assessed from data documented by the PN study records for each participant in the Intervention group
Number of PN contacts in Intervention Group12 monthsThis 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 Group12 monthsThis outcome will be assessed from data documented by the PN study records for each participant in the Intervention group

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORWendy Kuohung, MD

Boston Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026