PROPOSAL TITLE:  Physician-ordered Genetic Testing for Cancer Patients:  Improving Access and Equity through Mainstreaming

PROJECT LEAD(S):  Bethan Powell, MD; Amie Blanco, MS, CGC; Kelly Gordon, MS, MLIS

EXECUTIVE SPONSOR(S):   Laurel Bray-Hanin, VP, COO, UCSF Helen Diller Family Comprehensive Cancer Center

ABSTRACT:  National guidelines recommend germline genetic testing for many cancer indications to inform treatment decisions for patients and prevention in family members, but patient uptake of genetic testing is low both nationally and at UCSF and is subject to inequities.  Our current model for genetic testing delivery, the Genetic Testing Station (GTS), involves a multi-step workflow and patients are lost at each step, with Black and Non-English-speaking patients disproportionately impacted.  The model is also labor-intensive, requiring staffing by 2FTE genetic counselor assistants and 1FTE genetic counselor.  We propose to implement a provider-ordered genetic testing workflow called mainstreaming which will remove barriers to testing completion by reducing the steps involved.  The workflow is facilitated by a smartset in Apex to simplify the ordering process for providers, while genetics staff review genetic testing results and schedule positive patients for a genetic counselor visit.  We project that adoption of this workflow will result in cost savings and revenue enhancement totalling $338,510.

TEAM:  Bethan Powell, MD, Medical Director, Cancer Genetics and Prevention and Hereditary Cancer Programs; Amie Blanco, MS, CGC, Director, Cancer Genetics and Prevention and Hereditary Cancer Programs;   Kelly Gordon, MS, MLIS, Project Coordinator, Cancer Genetics and Prevention Program; Julie Mak, MS, CGC, Genetic Counselor Supervisor, Hereditary Cancer Program; Barry Tong, MS, MPH, CGC, Genetic Counselor Supervisor, Cancer Genetics and Prevention Program

PROBLEM:  Current national guidelines recommend germline genetic testing for several cancer indications including breast, ovarian, pancreatic, colorectal, and advanced prostate cancers.(1)  Many believe that in the near future guidelines will recommend that all patients diagnosed with a solid tumor undergo genetic testing to guide treatment decisions for themselves and to help their family members better understand their cancer risk. Despite the recognized utility of germline genetic testing, its overall uptake nationwide in patients with any cancer is only 7%, and uptake is still low even for the many cancers for which specific guidelines already exist.(2)  For instance, despite national guidelines recommending that all people with ovarian cancer should undergo germline testing, the rate of testing in ovarian cancer is only 39% nationally.  Minority populations are underrepresented with testing rates in Black ovarian cancer patients of only 29% (2). In a study of people with ovarian cancer at our own UCSF Gynecologic Oncology practice, we showed that only 53% were referred for genetic counseling, 33% underwent testing and there were inequities in services (3). 

In order to address growing referral volumes and need for quick access to germline genetic testing for cancer patients, in 2018 the UCSF Cancer Genetics and Prevention Program (CGPP) implemented a service model called the Genetic Testing Station (GTS), which since the COVID-19 pandemic has been conducted remotely.  GTS provides point-of-care expedited genetic services at the time of diagnosis for patients with multiple indications including ovarian, breast, pancreatic, colorectal, and advanced prostate cancers.  Patients are referred to the GTS by their oncologists, scheduled for a telephone visit with a genetic counselor assistant (GCA), sign a consent document, and provide a sample for genetic testing.  The GCA orders genetic testing for the patient, either through a third party laboratory or through UCSF’s Clinical Cancer Genomics Laboratory (CCGL) for those indications for which an appropriate CCGL test is available.  Results are shared with the referring provider in Apex.  Genetic counselors (GCs) review and disclose negative results to the patient via a letter in MyChart, while patients with positive results are scheduled for a video visit with a genetic counselor. (4,5)

The GTS model improved uptake of germline genetic testing, but disparities persisted.  Across all indications, 88% of 1699 cancer patients who were referred to GTS and seen for a GTS telephone visit between 3/2020 -6/2022 completed testing, but only 72% of our non-Hispanic Black patients and 79% of our Spanish-speaking patients completed testing, with similar trends seen within each indication (unpublished data -note that these figures do not include eligible patients that were not referred or patients that may have been lost from the workflow before the scheduling step).  The GTS model has also proved to be labor-intensive for genetics staff, requiring 1FTE GC and 2FTE GCA. Wasted labor costs result from: 1)  patient attrition from the multi-step genetic testing process, 2) inefficent workflows around placing genetic test orders with external third-party labs, and 3) use of GC time on non-billable administrative work (reviewing results, sending negative letters, sending requests to schedulers to schedule positive patients). 

TARGET:  The goals of this project are to 1)increase germline genetic testing completion rates for all patients seen at UCSF with new diagnoses of ovarian, breast, pancreatic, colorectal, or advanced prostate cancers, compared to current GTS testing completion rates; 2) reduce the disparities in germline genetic testing completion in comparison to the current GTS workflow; and 3) eliminate inefficiencies in current germline genetic testing workflows, allowing for the repurposing of GC time from non-billable administrative work to billable clinic hours. 

Quantitative benefits of the proposed intervention include:  1)  By increasing uptake of germline testing and reducing disparities, providers have the information they need to provide precision cancer care equitably to all patients.  2)  Increased uptake of testing also impacts patients’ family members, who may follow up with their own providers to pursue genetic testing for themselves or recommendations regarding screening and prevention measures.  Qualitative benefits of the proposed intervention include: 1) improved patient experience resulting from a more streamlined workflow; 2) improved provider experience resulting from increased availability of genetic test results to support treatment decision making for patients; 3) reduction in administrative burden for GCs, allowing more time to be devoted to working at the top of their license.

GAPS:   System gaps:  Genetic testing is currently a multi-step process and patients are lost at each step leading to lower rates of testing completion and increased labor costs.  Technological gaps:  Apex tools are needed to streamline genetics workflows and reduce labor costs.  Educational gaps:  Provider education is needed to: 1)  use the smartset to order germline genetic testing; 2)  discuss genetic testing with patients and obtain informed consent; 3) understand criteria for appropriate referrals for pre- or post- test counseling for patients with complex personal or family medical histories.  GCAs need training in administrative tasks surrounding results triage and scheduling of positive patients.

INTERVENTION:  Recently there have been several national and international trials of workflows involving direct physician ordering of germline testing (mainstreaming), increasing germline testing in cancer care and reducing workforce utilization (7,8). In Dr. Bethan Powell’s study of a mainstreaming workflow for ovarian cancer patients in Kaiser Permanente Northern California (KPNC), direct physician ordering of germline testing resulted in 100% uptake of germline testing at a KPNC site (Oakland) with a diverse racial, economic, and non-English speaking population, which was much higher than the 67% testing rate observed under the traditional pretest counseling model at other KPNC centers (8).

Dr. Powell’s work at KPNC identified several key advantages to mainstreaming germline genetic testing: 

• Physician recommendation significantly influences a patient’s choice to undergo germline testing. 
• Direct physician ordering reduces the number of steps involved in completing germline genetic testing and attendant workflow loss, which in turn increases germline testing in all cancer patients and therefore mitigates health inequities. 
• Mainstreaming allows GC expertise to be focused on counseling patients with positive results and their family members, while patients who test negative for a germline mutation can be informed by electronic letter. 

The CGPP team is working towards implementation of an innovative mainstreaming workflow that incorporates the advantages achieved at other institutions while ensuring our providers have enough support to adopt the workflow.  Our intent is to increase the efficiency of the process for all involved – oncology providers, patients, GCs, and genetics staff – not to simply shift the burden of work elsewhere.  We have already created and moved into production a smart set in Apex, with which the physician can document patient consent to germline genetic testing, place orders for the CCGL germline genetic test and for a blood draw for sample collection, and send the patient educational material with “just one click”. CGPP genetics staff will triage all results and handle results disclosure.  Patients with negative results will be notified via a letter in MyChart, whereas positive patients will be scheduled for genetic counseling to review results and recommendations for themselves and family members. Patients with complex histories or who need additional education may still be referred for formal genetic counseling before or after testing.

We plan to implement the workflow throughout the Cancer Center for all solid tumor diagnoses; however, the first tier of our implementation will concentrate on Cancer Center providers who see patients with indications that are currently served by GTS and for whom a CCGL comprehensive germline genetic test is available (providers in Gynecologic Oncology, Urologic Oncology, and Breast Surgery and Oncology).  Our team has already presented the workflow at clinician meetings and has received a positive response, including one comment that the process is easier than referring patients to GTS. We will introduce the workflow on a rolling basis in other departments (for instance, in GI Medical Oncology for colorectal and pancreatic cancer patients) when CCGL releases updates to the genetic test that cover these cancer indications later this year.

In 2021, 803 patients were seen at UCSF with a new diagnosis of breast cancer, 335 colorectal, 71 ovarian, 208 pancreas, and 264 with metastatic prostate cancer, for a total of 1,681 patients for whom germline testing is currently indicated under national guidelines.  The proposed intervention would ultimately increase access to genetic testing for all cancer patients with a solid tumor diagnosis seen at UCSF. 

Our intervention includes the following: 

• Support for providers in using the smartset and discussing genetic testing with patients through peer-to-peer training, tipsheets, on-demand videos, a 5-point script for patient consent, team meetings, and training of department champions to assist their colleagues
• Train providers on criteria for appropriate referrals for pre- or post-test genetic counseling for patients with more complex personal or family medical histories 
• Create a Cancer Genetics presence on the cancer-ops.ucsf.edu website for the posting of provider training materials, patient education videos, and handouts/brochures in both digital and print formats
• Create a patient-friendly educational brochure, translated into Arabic, Cantonese, Farsi, Japanese, Korean, Mandarin, Russian, Spanish, Tagalog, and Vietnamese
• Redeployment of our workforce to transfer administrative tasks surrounding results triage from GCs to GCAs, allowing 1FTE of GC (14 appointments per week) to be added back to our clinic schedule
• Development of supporting technologies in Apex (please see description below)
• Ongoing evaluation and assessment (please see attached evaluation plan), with development and implementation of strategies to address any disparities that are identified

We will assess the equitableness of the mainstreaming workflow in comparison to the GTS workflow using the following metrics:

• percent of eligible patients for whom testing is ordered
• percent of eligible patients who complete genetic testing
• workflow attrition points for those patients who do not complete testing
• turnaround times from placement of order to release of results

We will compare these metrics across patient demographic characteristics including race, ethnicity, age, gender, insurance, primary language, zip code, neighborhood deprivation index (NDI), and distance to care.  These data will be collected by means of an Apex report or dashboard (to be developed) that captures demographic and genetic testing data for all patients seen at UCSF for new diagnoses of ovarian, breast, pancreatic, colorectal, or advanced prostate cancers.  Assessment will occur on an ongoing basis and, if equity gaps persist, the study team will develop interventions to address gaps in partnership with stakeholders, including patients and ordering providers.  

PROPOSED EHR MODIFICATIONS:  We propose to develop Apex tools in support of 1) streamlining GCA workflows for results triage and workflow monitoring and 2) evaluation of the workflow, including detection of potential disparities.  We have already created the mainstreaming smartset and a reporting workbench that displays completed genetic test orders to facilitate results triage.  We propose the following tools and modifications:  1) enhancement of the existing reporting workbench to capture all orders placed under the smartset, so that GCAs can monitor orders and follow up on sample collection as needed;  2)  automation of negative patient letters in MyChart;  3) development of an outcomes report that captures all eligible patients seen at UCSF for a given indication, whether testing was ordered, test results, etc, to monitor utilization of the smartset, to detect disparities if they arise, to understand provider ordering patterns, and to measure completion of genetic testing across Cancer Services.

RETURN ON INVESTMENT (ROI):

Current workforce utilization: 

2FTE GCAs – GTS telephone encounters and administrative tasks

1FTE GC – GTS results triage, negative letters, and scheduling requests          

Proposed workforce utilization: 

1 FTE GCA, order monitoring, results triage, and scheduling

1 FTE GCA redeployed to clinic support

1 FTE GC – reassigned to clinic:

14 new clinic slots per week, 48 week year = 672 clinic slots/year

               Average net revenue/GC visit, FY23:  $216

               672 clinic slots/year * $216/visit

= $145,152 additional revenue per year

Current test utilization (2021 data):

1681 new patients seen at UCSF for breast, colorectal, ovary, pancreas and metastatic prostate cancers.

GTS =713 patients tested in 2021

Projected test utilization:

Mainstreaming: projected 90% test uptake = 1512 tests

1512 – 713 = 799 additional tests compared to current workflow

Contribution margin = $242/test

799 tests @ $242 /test

= $193,358 additional contribution margin per year

Total revenue enhancement = $338,510

SUSTAINABILITY:  This intervention has been designed to utilize existing CGPP staff and thus will not incur any ongoing operational costs beyond the funding year.  Proposed workflows, once in place, can be maintained with current staffing levels and in fact will alleviate staff burden.

BUDGET - Line-item budget up to $50,000 - Briefly identify key areas of the project that will require funding, e.g., salaries, software, printing, etc

1.  Project Coordinator Salary: 0.3 FTE @$125,400/yr = $37,620 

2.  Translation and printing of patient education brochure in 10 languages:

Translation Services:  $170/language x 9 languages = $1530

UCSF Documents and Media: $5,350 

Total Budget:  $44,500