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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Infertility Patient Navigator treatment?

Patient navigation has shown success in improving access to healthcare and outcomes in cancer care, particularly for underserved populations. This suggests that similar benefits could be seen in infertility care, as patient navigators help overcome barriers to accessing timely and complete health services. ^{1 2 3 4 5}

How is the Infertility Patient Navigator treatment different from other infertility treatments?

The Infertility Patient Navigator treatment is unique because it focuses on helping patients overcome barriers to accessing infertility care, such as financial, cultural, and logistical challenges, rather than directly treating the medical condition itself. This approach is similar to successful patient navigation programs in cancer care, which have improved access and outcomes for underserved populations. ^{2 3 6 7 8}

Research Team

Wendy Kuohung, MD

Principal Investigator

Boston Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Breast Cancer Navigation: Using Physician and Patient Surveys to Explore Nurse Navigator Program Experiences. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Patient navigation across the spectrum of women's health care in the United States. [2019]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A national patient navigator training program. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Mapping variation in intervention design: a systematic review to develop a program theory for patient navigator programs. [2020]