Ignite Creation Date:
2024-07-17 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481319
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Brief Title:
Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 labworkimaging 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 partners urology appointment the patients appointments such weight managementnutrition referral mammograms if indicated by age and insurance counseling if the participants 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
The study aims are to
1 evaluate the impact of the PN program on timelines including obtaining commercial insurance coverage for infertility expediting labworkimaging 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 partners urology appointment the patients appointments such weight managementnutrition referral mammograms if indicated by age and insurance counseling if the participants 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None