Cascade Genetic Testing Chatbot
Title: Cascade Genetic Testing Chatbot
Document Type: Sources Sought Notice
Solicitation Number: 75N91019Q00103
Posted Date: 07/18/2019
Response Date: 07/29/2019
Classification Code: Q601 - Medical - Laboratory Testing
NAICS Code: 511210 - Software Publisher ($38,500,000.00)
Contracting Office Address
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Bethesda, MD 20892.
Description
This is a sources-sought to determine the availability of potential sources having the skills and capabilities necessary to perform/provide the SPECIFIED REQUIREMENT. All interested vendors are invited to provide information to contribute to this market survey/sources sought synopsis only. Questions should be submitted by email to william.neal@nih.gov. Provide only the requested information below. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub-zone, 8(a), small, small disadvantage, woman-owned small business, or large business) relative to 511210 NAICS Code for Software Publisher. Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources-sought synopsis, a solicitation announcement may be published on the FBO website. Responses to this sources-sought synopsis are not considered adequate responses to any future solicitation announcements. All interested offerors will have to respond to the solicitation announcement in addition to responding to this sources-sought announcement.
The National Cancer Institute (NCI) Center for Cancer Research (CCR), Genetics Branch, Clinical Cancer Genetics Programs plan to conduct a study to compare standard of care (SOC) family communication counseling plus a cascade Chatbot to SOC family communication counseling only on first, second, and/or third-degree relatives at-risk to inherit a pathogenic gene variant. If the chatbot proves to be superior to standard of care, the NCI will consider whether to continue to utilize the Cancer Genetic Cascade Testing Chatbot or begin development of an NCI Chatbot tool.
Genetic testing to identify patients with pathogenic or likely pathogenic (P/LP) variants associated with hereditary cancer predisposition is increasingly being integrated into health care. Potential health benefits for patients identified with a cancer predisposition P/LP variant include identifying cancers at early stages with intensive surveillance, possibly reducing cancer risk with risk reducing surgery and avoiding increased intensive surveillance as well as additional healthcare costs for those individuals who have not inherited the cancer predisposition. Therefore, efforts to identify as many patients at increased risk will reduce the risk of cancers, increase life expectancy and reduce healthcare costs by averting expensive cancer treatments with risk reducing strategies. Additionally, genetic testing costs are lower when at-risk relatives undergo targeted testing for the P/LP variant in the family rather than full analysis of gene(s) of interest. Genetic testing will be most effective in reducing cancer risk if the variant status of all at-risk relatives is determined. This requires making relatives aware of their at-risk status and the availability of genetic testing to determine whether they inherited the P/LP variant.
Cascade genetic testing is an active process to identify relatives at-risk for a genetic condition by following the logical path of a P/LP variant in the family. Cascade testing begins with first-degree relatives and then extends to second- and third-degree relatives in a stepwise, cascade fashion, moving through the pedigree in sequential steps as additional family members are identified with the P/LP variant. Cascade genetic testing is critically important to maximize the identification and medical management of individuals with P/LP variants associated with increased cancer risk. Cascade genetic testing is most effective when at-risk relatives are first notified of their risk, the health implications of the P/LP gene variant in their family, and the availability of testing, with subsequent uptake.
Current Standard of Care
In current clinical practice, the majority of health care professionals encourage the proband to share genetic information with their families. In 1998 the American Society of Human Genetics (ASHG) issued a statement providing guidance about cascade genetic testing. The statement recommends that providers initiate the cascade process by instructing the proband to communicate information about the P/LP variant to at-risk family members. While ASHG has taken a stance on how the process should be initiated, they do not provide strategies for how the process should be implemented in a way that fits into healthcare models and diverse daily clinic workflows. ASHG also has not updated their recommendation and other national genetics organizations, such as the American College of Medical Genetics do not have practice guidelines about cascade genetic testing. In January 2018 the American College of Obstetricians and Gynecologists (ACOG) issued a population specific committee opinion regarding cascade genetic testing for women at-risk for familial P/LP variants associated with gynecologic as well as other cancers. ACOG recommends that obstetricians-gynecologists (OB/GYNs) inform patients who test positive for a P/LP variant that they have a duty to notify relatives of the familial risk and that is it neither required nor appropriate for OB/GYNs to directly contact and notify at-risk family members. The current approach for cascade testing in a clinical setting, which has remained unchanged over the last 20 years, generally includes the following steps: 1) constructing a pedigree that facilitates identification of the proband's at-risk relatives who should be offered testing, 2) discussing risk notification with the proband, and 3) providing the proband with written educational information, such as a patient letter, to share with their relatives. The educational information typically includes general information about the P/LP variant, whether there are screening and risk reducing options available, and health consequences without testing.
Uptake of Testing Using Standard of Care
Studies have found that relying on probands to contact their family members and refer them to local cancer genetics providers has not been a very successful approach to promote cascade testing among at-risk relatives, with only 20-52% of at-risk relatives following through with genetic counseling and/or testing.
Genetic testing uptake rates after genetic counseling may be impacted by at- risk relatives gaining an in-depth understanding of the meaning and implications of testing through the education process. Therefore, if at-risk relatives do not understand the proband's test results or are not informed by probands about their risk status and the option of genetic counseling, then they may never receive the proper education to make an informed choice. For instance, a study by Daly et al. of 561 first degree relatives (FDR) of probands who had undergone BRCA1/2 genetic testing and subsequent training on cascade testing found that 22% of FDR reported that the proband had not shared test results with them, despite the proband having reported that they had communicated their test results. When FDR were informed of the results by the proband, the same study also found that 18% of FDR had interpretations of the result that were discordant with the actual result and 10% of FDR did not remember the result at all. The study illustrates some of the limitations of relying on the proband to convey genetic information to their at-risk relatives and highlights the importance of providing probands and at-risk relatives with ongoing education and readily accessible educational resources to aid in the communication process.
Initiatives to increase the accurate dissemination of cascade genetic testing have been studied and include indirect methods, such as training probands to increase their capacity to communicate genetic information to their relatives and computerized assistance through the Kintalk website, to direct methods of clinicians contacting at-risk relatives on their patient's behalf a strategy, to barrier reduction methods with free testing of the P/LP variant offered by some clinical laboratories. Direct methods are not feasible given the shortage of cancer genetic counselors. None of the alternate methods have been robustly evaluated with a randomized controlled study comparing usual care to the intervention.
The NCI Genetics Branch has been investigating mechanisms available that have the potential to increase update of Cascade testing. A comprehensive review of the literature mirrored our findings that there are no standardized methods to optimize the cascade genetic testing process. Studies have shown that relying on probands to communicate their results to at-risk relatives is a suboptimal strategy resulting in low genetic testing uptake. There is a gap in the literature regarding cascade testing interventions research using rigorous randomized controlled trials. To reduce communication and geographical barriers as well as reliance on the proband, we propose to use a Chatbot to provide at-risk relatives with educational information about the familial P/LP, which simulates an encounter with a genetic counselor.
Chatbots
Chatbots are an application of Artificial Intelligence (AI) that simulate conversations in the way people would naturally speak to one another. Chatbots use sophisticated natural language processing systems to automate text-based dialogues. Chatbots are also referred to as conversational agents and are the technology behind Apple's Siri and Amazon's Alexa. Chatbots are being explored as an alternative way to offer intelligent responses to patient questions as they review test options and collect information in preparation for an appointment with a healthcare provider. An analysis of 24 studies of chat or text messaging interventions found them acceptable and feasible as a mode of therapeutic support.
Cancer Genetics Cascade Testing Chatbot
To date, there have been no randomized controlled studies exploring the impact of technology-based interventions on cascade genetic testing outcomes. Therefore, the NCI Genetics Branch plans to conduct a study to compare standard of care (SOC) family communication counseling plus a cascade Chatbot to SOC family communication counseling only on first, second, and/or third-degree relatives at-risk to inherit a pathogenic gene variant.
OBJECTIVE
the NCI Genetics Branch has been investigating mechanisms available that have the potential to increase update of Cascade testing. Given the well-recognized shortage of genetic counselors and others sufficiently trained in genetics, informatic options to supplement standard of care cascade testing was determined to be the best option to explore. Chatbots were then selected as they are flexible, have been found to be acceptable and feasible, and Chatbots can be easily updated as the evidence base evolves.
The NCI Genetics Branch plans to conduct a prospective study comparing standard of care (SOC) family communication counseling plus a cascade Chatbot to SOC family communication counseling only on first, second, and/or third-degree at-risk relatives.
SCOPE
The scope of work includes access to a fully automated HIPAA-compliant chatbot with a user interface similar to that of a smartphone text messaging app which can deliver high-quality genetic information to at-risk patients including personalized information about the significance of test results, provide text-friendly links to alert at-risk family members, and manage follow-up patient action items (e.g. schedule medical tests). The Chatbot must include options for the patients to reply back to the Chatbot by choosing from preset options or by typing in free text, thus navigating the conversation based on their specific clinical situation and alleviating the need for a scheduled appointment. A transcript of each encounter the patient has with the Chatbot needs to be stored in a secure database and transferred to the NCI Genetic Branch on a quarterly basis.
1. Editing Feature:
a. Customized script iteration which would allow the NCI Genetics Branch to make authoritative script iterations based on the evolving evidence base, analytics and/or new intents/questions coming from our patients.
2. Auto-Populate Gene Specific Scrip:
a. Given that Cascade testing has core information that remains relatively constant, the NCI Genetics Branch requires one single template script that can be readily modified for things such as mode of inheritance, and the specific gene (and associated mutation) which would permit the script to then be auto-populated.
3. Chabot Prompt:
a. Once the invitation is sent to the patient, the Chatbot can auto-remind the patient to open it. To date, it takes approximately 3 reminders before a patient engages with the chat.
4. HIPAA Compliance:
a. The platform must meet the regulatory requirements of HIPAA for these types of patient interactions.
5. Cascade Bot:
a. The Chatbot shall be specific to the patient's results that he/she can share with a partner or relative. Using this tool enables tracking of whether patients share results and how often.
6. Smart FAQ:
a. The Genetic Information Assistant (GIA) shall be trained to answer frequently asked questions (in the genetic testing space) using Natural Language Understanding/Processing (NLP/NLU) and shall have the ability to customize the responses for all the intents that GIA supports.
1.0 CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS
Contractor shall perform the following tasks:
1.1 Project Management Plan
1.1.1 Contractor shall develop an overall project plan for the Scope of the project. The Project Management Plan shall describe the development and implementation of the requirements under this contract and detail the timing and mode of key operations.
1.1.2 Contractor will work with the NCI Genetics Branch to customize their pre-existing Chatbot. This will include working closely with the NCI Genetics Branch cascade testing research team, updating the Chatbot script as requested, adding content for the Chatbot on genes not already available, and any additional modifications to assure that the Chatbot is customized.
1.1.3 Contractor will provide HIPAA compliant access links to the Chatbot.
1.1.4 Contractor will also provide outcome analytics related to time and length of utilization and what questions are being asked of the Chatbot by users.
1.1.5 Contractor will complete as requested additional customization content as the evidence base and resources available continue to evolve to keep the Chatbot current.
1.1.6 Contractor will also provide links for Chatbot users to resources, surveys and
All responses and questions shall be emailed to William Neal, Contracting Officer, via electronic mail at william.neal@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through SAM.gov. Reference: 75N91019Q00103 on all correspondence.
This notice is not a request for competitive quotation. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received via electronic mail at william.neal@nih.gov by 12:00 PM EST, on July 29, 2019.
Responses should include both the STATEMENT OF CAPABILITY and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained below. This notice is to assist with determining sources only. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.
REQUESTED INFORMATION: (1) STATEMENT OF CAPABILITY: Submit a brief description [ten (10) pages or less] that includes product specifications. Include past experience with performing this type of service for Government (Federal or State) agencies, or for a private medical facility. Please indicate your address (2) BUSINESS SIZE AND SOCIO-ECONOMIC STATUS: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub-zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB)(g) Include the DUNS number of your firm. (h) State whether your firm is registered with SAM System for Award Management www.sam.gov/. If not, please NOTE: any future solicitation can only be awarded to a contractor who is registered in SAM.
William T. Neal, Contract Specialist, Phone 2402765433, Email william.neal@nih.gov - Miguel Diaz, Contracting Officer, Phone 2402765439, Email miguel.diaz@nih.gov
