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临床试验/NCT06481319
NCT06481319已完成不适用

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

Boston Medical Center1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Time to start fertility treatments

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients in whom fertility treatment with their own eggs is not recommended, egg freezing or oncofertility cycles.
  • Non-English speaking

研究组 & 干预措施

Infertility Patient Navigator Group

Experimental

Participants in this group will receive assistance from the Infertility Patient Navigator (PN) to schedule and complete the infertility evaluation.

干预措施: Infertility Patient Navigator (Behavioral)

Historical Comparison Group

No Intervention

Age-matched controls selected from the electronic medical record database who received infertility evaluation without PN assistance.

结局指标

主要结局

Time to start fertility treatments

时间窗: 12 months

This outcome will be assessed by data abstracted from the EMR.

Wait time for urology appointments

时间窗: 12 months

This outcome will be assessed by data abstracted from the EMR.

Wait time for weight management appointments

时间窗: 12 months

This outcome will be assessed by data abstracted from the electronic medical record.

Time to complete infertility evaluation

时间窗: 12 months

This outcome will be assessed by data abstracted from the electronic medical record (EMR).

次要结局

  • Time to live birth(12 months)
  • Number of PN contacts in Intervention Group(12 months)
  • Pregnancy rate(12 months)
  • Frequency of PN contacts in Intervention Group(12 months)
  • Duration of PN contacts in Intervention Group(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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