Patient Navigator Program for Infertility

Overseen By Wendy Kuohung, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to help individuals struggling with infertility receive care more quickly and easily. The program provides a Patient Navigator to assist with scheduling tests and appointments, handling insurance issues, and offering support throughout the process. The researchers aim to determine if this additional support can expedite the start of fertility treatments for underserved patients at Boston Medical Center. Ideal participants are new patients at the center seeking help with infertility who speak English. The trial seeks to improve access to fertility care for those who often face difficulties in obtaining treatment. As an unphased trial, it offers a unique opportunity to contribute to enhancing fertility care access for underserved communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Patient Navigator program is safe for infertility care?

Research shows that programs like the fertility navigator under study are generally safe and well-liked by patients. Previous studies have found that fertility navigators provide personal care and support, enhancing patient satisfaction during their fertility journey. These programs clarify fertility risks and options, especially in complex medical situations, without any known safety issues. The primary role of these navigators includes assisting with scheduling, referrals, and understanding test results. These tasks are standard in fertility care and do not involve direct medical treatment. Therefore, using a Patient Navigator in this setting is considered safe, as no problems have been reported related to their involvement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Infertility Patient Navigator program because it introduces a personalized approach to infertility treatment. Unlike current options that often leave patients navigating complex medical systems alone, this program provides dedicated assistance to help individuals schedule and complete their infertility evaluations. By offering tailored support, the program aims to reduce stress and improve the overall experience for patients, potentially leading to better outcomes. This innovative method focuses on enhancing patient engagement and satisfaction, which could transform how infertility care is delivered.

What evidence suggests that the Infertility Patient Navigator program is effective for improving infertility care access?

Research has shown that patient navigators improve access to healthcare, including fertility care. In this trial, participants in the Infertility Patient Navigator Group will receive assistance from a fertility navigator. Studies have found that fertility navigators can expedite the start of fertility tests and treatments. This support is especially beneficial for communities that often face challenges in accessing specialized care. Working with fertility navigators has enhanced patients' understanding of their fertility options and increased satisfaction with their care. By assisting with tasks like scheduling appointments and managing insurance, these navigators streamline the fertility treatment process. ^{1 2 3 6 7}

Who Is on the Research Team?

Wendy Kuohung, MD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals facing infertility issues who are part of an underserved population at Boston Medical Center. They should be seeking infertility care and have not yet completed their fertility evaluation or started treatment.

Inclusion Criteria

I am a new patient seeking infertility diagnosis at BMC between July 2024 and January 2025.

I am a new patient seeking infertility diagnosis at BMC between July 2023 and January 2024.

Exclusion Criteria

Patients in whom fertility treatment with their own eggs is not recommended, egg freezing, or oncofertility cycles

Non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Participants receive assistance from the Patient Navigator to complete infertility evaluation, including scheduling labwork, imaging, and partner urology appointments

12 months

Multiple visits as needed for evaluation and testing

Treatment Initiation

Participants begin fertility treatment if recommended, with assistance from the Patient Navigator

12 months

Visits as required for treatment initiation

Follow-up

Participants are monitored for outcomes such as pregnancy rates and time to live birth

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Infertility Patient Navigator

Trial Overview The study tests a Patient Navigator program designed to help participants navigate the healthcare system, reduce wait times for insurance coverage, lab work, appointments, and start of fertility treatment. It compares outcomes with patients from the previous year without this assistance.

How Is the Trial Designed?

Group I: Infertility Patient Navigator Group Experimental Treatment 1 Intervention

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

Group II: Historical Comparison Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Published Research Related to This Trial

A systematic review of seven studies highlights the effectiveness of oncology nurse practitioner navigators in improving timely care and enhancing patient and staff satisfaction.

The review emphasizes the importance of well-defined metrics for evaluating navigation programs, aligning with expert consensus recommendations, while also calling for more rigorous research tools in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of oncology nurse practitioner navigation metrics. Johnson, F.[2022]

A systematic review of 21 publications on patient navigator (PN) interventions identified 17 unique activities, with the most common being education, referrals, and emotional support, aimed at helping patients access and adhere to care.

The final program design for a PN intervention included 13 activities, demonstrating that targeting barriers like knowledge, scheduling, and insurance can lead to positive outcomes in patient care, highlighting the need for better reporting of intervention components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping variation in intervention design: a systematic review to develop a program theory for patient navigator programs. Desveaux, L., McBrien, K., Barnieh, L., et al.[2020]

The breast cancer navigation (BCN) program significantly improved physician workflows, with many physicians stating it made their day easier and enhanced care coordination and patient experience.

Patients also reported high satisfaction with the support they received during diagnosis communication, indicating that the BCN program effectively met their needs during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer Navigation: Using Physician and Patient Surveys to Explore Nurse Navigator Program Experiences. Dillon, EC., Kim, P., Li, M., et al.[2021]

Patient navigation is an effective intervention that helps patients overcome barriers to healthcare access, particularly in cancer care, leading to increased screening rates and improved health outcomes for underserved populations.

The success of patient navigation in reducing disparities in cancer care suggests it could also enhance access and outcomes in obstetric and gynecological care, warranting further investigation into its broader applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation across the spectrum of women's health care in the United States. McKenney, KM., Martinez, NG., Yee, LM.[2019]

A study involving 1345 patients with abnormal cancer screenings or cancer diagnoses found a significant correlation between satisfaction with patient navigators and overall satisfaction with cancer-related care, indicating that effective navigation can enhance patient experiences.

Factors such as having an abnormal colorectal cancer screening and being older or from a minority racial-ethnic background were linked to higher satisfaction levels, suggesting that tailored navigation support may help address disparities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. Jean-Pierre, P., Cheng, Y., Wells, KJ., et al.[2022]

A standardized national training program for patient navigators (PNs) was successfully implemented, attended by 116 PNs from 85 cities, aimed at reducing cancer health disparities for medically underserved populations.

The training showed significant efficacy, with overall improvements in posttest scores compared to pretest scores, particularly among participants with higher education levels or more work experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national patient navigator training program. Calhoun, EA., Whitley, EM., Esparza, A., et al.[2021]

The Spanish version of the Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I-Sp) scale was validated with 222 Spanish-speaking participants, showing high internal consistency (α = 0.97) and a one-dimensional structure that explained 82% of the variance.

The PSN-I-Sp demonstrated good validity and was effectively correlated with the Spanish version of the Patient Satisfaction with Cancer-Related Care (PSCC-Sp), indicating it is a reliable tool for assessing satisfaction with patient navigators among Spanish-speaking cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-cultural validation of a Patient Satisfaction with Interpersonal Relationship with Navigator measure: a multi-site patient navigation research study. Jean-Pierre, P., Fiscella, K., Winters, PC., et al.[2021]

The Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure was validated in a study involving 783 participants, demonstrating high internal consistency and reliability (α ranging from 0.95 to 0.96).

The PSN-I effectively captures patient satisfaction with navigators, showing strong correlations with existing satisfaction measures, which suggests it is a reliable tool for assessing the quality of support provided to underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Jean-Pierre, P., Fiscella, K., Winters, PC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7686182/

Fertility navigators in female oncofertility care in an ... Patients were satisfied about the supportive role of the fertility navigator in their fertility preservation process: fertility navigators added ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pbc.29857

The impact of hiring a full‐time fertility navigator on fertility ... Fertility navigators (FNs) are important in communicating infertility risk and fertility preservation (FP) options to patients receiving gonadotoxic therapies.

3. withpower.com withpower.com/trial/phase-infertility-8-2024-71b5c

Patient Navigator Program for Infertility What data supports the effectiveness of the Infertility Patient Navigator treatment? Patient navigation has shown success in improving access to healthcare ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06481319

Implementing a Pilot Patient Navigator Program to Improve ... The primary objective is to assess whether the PN program can significantly reduce time to completion of infertility evaluation and to initiation of fertility ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11782191/

Impact of a Nurse Navigator Program on Referral Rates ... A Nurse Navigator Program facilitates the referral pathway for patients with a cancer diagnosis interested in fertility preservation and results in higher ...

6. pediatricsnationwide.org pediatricsnationwide.org/2022/07/28/fertility-navigators-support-important-consultations-in-pediatric-settings/

Fertility Navigators Support Important Consultations in ... “The fertility navigator has a lot of important roles, including counseling, risk assessments, interpreting test results, making referrals and ...

7. aonnonline.org aonnonline.org/blog/oncofertility-navigation-provides-fertility-assistance-for-patients-with-cancer

Oncofertility Navigation Provides Fertility Assistance for ... Cancer treatments may cause impairment of fertility, and fertility preservation provides patients with options for family-building after they successfully ...