Clinical trial NCT06481319: Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients
Official title: Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Keywords: Infertility Patient Navigator (PN)
Under-resourced patients
Cycle based testing
Urology appointments
Health Literacy
Boston Medical Center
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group intervention with age-matched historical controls
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Time to complete infertility evaluation
timeFrame: 12 months
measure: Time to start fertility treatments
timeFrame: 12 months
measure: Wait time for urology appointments
timeFrame: 12 months
measure: Wait time for weight management appointments
timeFrame: 12 months
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 12 months
measure: Time to live birth
timeFrame: 12 months
measure: Frequency of PN contacts in Intervention Group
timeFrame: 12 months
measure: Number of PN contacts in Intervention Group
timeFrame: 12 months
measure: Duration of PN contacts in Intervention Group
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center, Reproductive Endocrinology
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Wendy Kuohung, MD
role: PRINCIPAL_INVESTIGATOR
References: