Trainee-Led Quality Improvement Project to Improve Fertility Preservation Counseling for Patients With Cancer

PURPOSE:

Oncofertility counseling regarding the reproductive risks associated with cancer therapy is essential for quality cancer care. We aimed to increase the rate of oncofertility counseling for patients of reproductive age (18-40 years) with cancer who were initiating systemic therapy at the Johns Hopkins Cancer Center from a baseline rate of 37% (25 of 68, June 2019-January 2020) to 70% by February 2021.

METHODS:

We formed an interprofessional, multidisciplinary team as part of the ASCO Quality Training Program. We obtained data from the electronic medical record and verified data with patients by phone. We surveyed patients, oncologists, and fertility specialists to identify barriers. After considering a prioritization matrix, we implemented Plan-Do-Study-Act (PDSA) cycles.

RESULTS:

We identified the following improvement opportunities: (1) oncologist self-reported lack of knowledge about counseling and local fertility preservation options and (2) lack of a standardized referral mechanism to fertility services. During the first PDSA cycle (February 2020-August 2020, disrupted by COVID-19), we introduced the initiative to increase oncofertility counseling at faculty meetings. From September 2020 to November 2020, we implemented a second PDSA cycle: (1) educating and presenting the initiative at Oncology Grand Rounds, (2) distributing informative pamphlets to oncologists and patients, and (3) implementing an electronic medical record order set. In the third PDSA cycle (December 2020-February 2021), we redesigned the order set to add information (eg, contact information for fertility coordinator) to the patient after-visit summary. Postimplementation (September 2020-February 2021), counseling rates increased from 37% to 81% (38 of 47).

CONCLUSION:

We demonstrate how a trainee-led, patient-centered initiative improved oncofertility care. Ongoing work focuses on ensuring sustainability and assessing the quality of counseling.

INTRODUCTION

The Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins University (JHU) in Baltimore, MD, provides cancer care to thousands of patients annually across five outpatient sites. Providing excellent cancer care, including supportive care services, is a cornerstone of the mission. Systemic therapy for cancer, including chemotherapy, targeted therapy, and immunotherapy, is associated with decreased fertility.^1,2 Counseling regarding this reproductive risk and facilitating access to fertility preservation services is essential for quality care and recommended by oncology guidelines.^3-5 Oncofertility counseling is associated with higher rates of referral to reproductive specialists, pursuit of fertility preservation, conception, and improved quality of life.^6,7

Previous work has identified low rates of fertility counseling nationally; data from the ASCO Quality Oncology Practice Initiative (QOPI) indicate that over a 5-year period from 2015 to 2019 across 400 practices, only 44% of patients of reproductive age were counseled regarding the risks of infertility associated with chemotherapy.⁸ During a JHU Hematology and Oncology Fellowship Quality Improvement (QI) monthly meeting in 2019, fellows reported frustration regarding their current knowledge of best practices for fertility counseling and mechanisms of specialist referral. Therefore, we evaluated institutional data and found that from June 2019 to January 2020, only 37% (25 of 68) of eligible patients received fertility counseling. We also noted that (1) the SKCCC is a National Cancer Institute (NCI)–designated comprehensive cancer center with access to reproductive specialists and (2) in 2018, Maryland legislatively mandated coverage of fertility preservation services. Thus, suboptimal internal processes were likely responsible for the low counseling rates.

We conducted a QI initiative to increase the rate of fertility counseling for patients of reproductive age (18-40 years) with cancer who were initiating systemic therapy at the SKCCC from a baseline of 37% to 70% by February 2021.

METHODS

Team Composition

With support from SKCCC and fellowship leadership, Hematology Oncology fellows assembled an interprofessional, multidisciplinary team and participated in the 2020 ASCO Quality Training Program. Other team members included the Quality Training Program coach, fertility experts (reproductive endocrinology and urology), a patient representative, an information technology designer, social workers, a graphic art designer, and fellowship and SKCCC leadership. This study was undertaken as a Not Human Subjects Research/QI initiative, and so as per institutional policy, Institutional Review Board approval was not required.

Study Population, Measures, and Data Sources

We included patients age 18-40 years with newly diagnosed cancer who were initiating systemic therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy, or biologic therapy) at SKCCC and who were evaluated by a medical oncologist in clinic. The outcome measure was the proportion of eligible patients who received fertility preservation counseling before initiating systemic therapy. We selected this measure because (1) it is a QOPI metric with clinical validity and (2) we expected this to be an actionable measure. We collected baseline rates of counseling by reviewing the electronic medical record (EMR) and, in particular, notes by the primary oncologist. Previous work has used documenting counseling as a metric.⁸ However, we recognized that documentation may not accurately capture the breadth of patient experience and we subsequently opted to verify EMR data with patients directly by phone using a standardized script. We collected demographic and other reproductive data and the proportion of patients referred to reproductive specialists and pursuing fertility preservation. We collected baseline data (June 2019-January 2020) in February 2020 and monthly during the Plan-Do-Study-Act (PDSA) cycles.

Diagnostic Data and Barriers to Optimal Care

Core members met weekly during the project. The workflow (process map) for a new patient arrival to receipt of therapy (Appendix Fig A1, online only) revealed that interventions were possible at multiple touches, primarily through oncologists. We distributed an e-mail survey to 51 oncology faculties regarding barriers to counseling, received 26 responses, and created a Pareto chart (Appendix Fig A2, online only). We reviewed current referral processes and surveyed reproductive specialists and social work to explore optimal workflows and to identify local fertility preservation resources. We created a cause-and-effect diagram (Appendix Fig A3, online only). Key themes included the following: (1) oncologist underconfidence about counseling and lack of knowledge about local fertility preservation options and (2) lack of a standardized referral mechanism to specialty services. We considered possible interventions and selected interventions using an Action Priority Matrix.

PDSA Cycle 1: Maintaining Engagement Through COVID-19

We planned PDSA cycle 1 in February 2020. Because of the COVID-19 surge, we did not proceed with planned interventions (which were moved to PDSA cycle 2) but presented this initiative at small disease-specific meetings to maintain engagement.

PDSA Cycle 2: Educating and Implementing a Standardized Order Set

In September 2020, we implemented a second PDSA cycle. Our interventions included (1) presenting the baseline data, the fellow-led initiative, and education at Oncology Grand Rounds (attended by 150 staff members); (2) creating and distributing paper and electronic pamphlets to oncologists and patients (Data Supplement, online only); and (3) implementing an EMR order set. The presentation and pamphlets served to increase awareness and education. The order set served to standardize referral to reproductive specialists since lack of knowledge as to where to send referrals was a key barrier. This order set included instructions for providers and patients, necessary laboratory studies, and a referral to reproductive endocrinology or orders for cryopreservation of sperm (Fig 1 and Appendix Fig A4, online only).

FIG 1.

Female oncology fertility preservation order set. AMH, anti-mullerian hormone; AVS, after-visit summary; HBV, hepatitis B virus; HCV, hepatitis C virus.

PDSA Cycle 3: Optimizing the Order Set

In December 2020, we amended the order set to automatically add the following to the patient after-visit summary: contact information for a dedicated fertility coordinator, estimated costs of services, and financial assistance programs.

During the phone call to patients to assess counseling, patients who reported no counseling were encouraged to contact their oncologist and made aware of resources available at the specific stage of the QI project.

Data Analysis

We used a statistical process control chart method to examine rates of counseling using SPC Software for QI Macros, v2020, KnowWare International, Inc, Denver, CO.

RESULTS

There was no significant difference in patient characteristics (age distribution, sex, race, ethnicity, and cancer site) in the preintervention and postintervention groups. A majority of patients were women, the median age was 34 years, and the most common cancer sites or types were breast, lymphoma, and sarcoma. The median number of children before cancer diagnosis was 1. All patients were identified as heterosexual.

Compared with the baseline counseling rate of 37%, during PDSA cycle 1 (February-August 2020), 62% (16 of 26) of patients reported counseling. Over PDSA cycles 2 and 3 (September 2020-February 2021), 81% (38 of 47) of patients reported counseling. A sustained shift in the process was apparent on the control chart (Fig 2).

FIG 2.

Statistical process control chart demonstrating the baseline and postintervention rates of fertility preservation counseling (percentage) at Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, MD. The counseling rate increased from 37% (baseline) to 81% (postintervention). Data were collected from the electronic medical record and verified with patients. CL, central line; LCL, lower control limit; PDSA, Plan-Do-Study-Act; UCL, upper control limit.

For secondary measures, we noted that proportion of eligible patients who were referred to reproductive specialists were 12%, 11%, and 15% over the baseline, PDSA cycle 1, and PDSA cycles 2 and 3, respectively. Rates of pursuing fertility preservation were 18%, 16%, and 26% over the baseline, PDSA cycle 1, and PDSA cycles 2 and 3, respectively. Interviews with oncologists and reproductive specialists noted no adverse balancing measures, including no prolongation of clinic appointments, no delays in initiation of cancer therapy, and no overburdening of the Andrology lab and/or Reproductive Endocrinology and Infertility clinic.

DISCUSSION

In this QI study at an NCI-designated comprehensive cancer center, a trainee-led, interprofessional, patient-centered initiative improved fertility care services for patients with cancer, despite disruptions caused by the COVID-19 pandemic.

A major challenge during this initiative was the COVID-19 pandemic. We believe that a key success strategy was our flexibility. We hibernated without disappearing completely and avoided irrelevance and losing sponsorship by presenting the initiative at small group meetings. Having a core team of fellows with a shared vision helped the team bounce back with energy once restrictions eased. Support from program and cancer center leadership was critical. Another factor contributing to the success of this initiative was our multipronged approach. Oncologists reported underconfidence in counseling as a key issue; unfortunately, fertility preservation principles remain undertaught in oncology curriculum.^9-11 Similar to our diagnostic data, previous qualitative data from Canadian oncofertility clinicians demonstrated that a major barrier to appropriate counseling is clinician unfamiliarity (with infertility risks and referral processes).¹² In another report, oncologists across practice settings rated fertility preservation as the most difficult QOPI measure to influence.¹³ We recognized the need to educate oncologists, but we also recognized that education alone is a weak intervention.¹⁴ To address this, we leveraged information technology resources to create an order set. This not only standardized access to specialty fertility services but also served as a ready resource and reminder for busy oncologists, while being a durable and modifiable intervention. We believe that recent legislation in Maryland mandating coverage for fertility preservation, collating local resources in conjunction with reproductive experts, and providing estimated costs and financial support programs to patients also contributed to our success.

Ongoing work focuses on ensuring project sustainability through (1) fellowship investment in QI support and education so that new cohorts of fellows can carry this project forward (and start new ones); (2) addressing fertility counseling documentation, making it easier to monitor change without relying on patient interviews; and (3) nurse leaders in urology or reproductive endocrinology and infertility taking over the order set maintenance. We are also assessing the quality of counseling and evaluating the impact on utilization of fertility care services. Limitations of this work include the potential for recall bias when verifying data with patients (especially in the baseline period), bunching together interventions such as it is impossible to delineate their individual impact (education and order set in PDSA cycle 2), and restricting the scope of the project to men and women under age 40 years and to the outpatient setting. We are expanding this work to inpatients (largely patients with newly diagnosed hematologic malignancy initiating urgent therapy).

APPENDIX

FIG A1.

Flowchart demonstrating flow of patient from being evaluated in outpatient oncology clinic to receiving systemic cancer therapy. H&P, history and physical examination; pt, patient.

FIG A2.

Pareto chart demonstrating the top causes of low fertility preservation counseling rates as voted on by oncologists.

FIG A3.

Fishbone diagram demonstrating the potential causes of low fertility preservation counseling rates. EMR, electronic medical record.

FIG A4.

Male oncology fertility preservation order set.

AUTHOR CONTRIBUTIONS

Conception and design: Laura A. Sena, Ramy Sedhom, Susan Scott, Amanda Kagan, Andrew H. Marple, Jenna V. Canzoniero, Lauren Reschke, Maria Facadio Antero, Mindy S. Christianson, Allen R. Chen, Arjun Gupta

Financial support: Allen R. Chen, Arjun Gupta

Administrative support: Ross C. Donehower, Arjun Gupta

Collection and assembly of data: Laura A. Sena, Ramy Sedhom, Susan Scott, Andrew H. Marple, Jenna V. Canzoniero, Melinda Hsu, Mindy S. Christianson, Kristen A. Marrone, Arjun Gupta

Data analysis and interpretation: Laura A. Sena, Ramy Sedhom, Susan Scott, Jenna V. Canzoniero, Syed M. Qasim Hussaini, Amin S. Herati, Mindy S. Christianson, Adam F. Binder, Allen R. Chen, Ross C. Donehower, Kristen A. Marrone, Arjun Gupta

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Trainee-Led Quality Improvement Project to Improve Fertility Preservation Counseling for Patients With Cancer

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/op/authors/author-center.

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