NIH/NCI 453 – Digital Tools to Integrate Cancer Prevention Within Primary Care

Fast-Track proposals will be accepted.

Direct-to-Phase II proposals will be accepted.

Number of anticipated awards: 3-5

Budget (total costs, per award):

Phase I: up to $400,000 for up to 12 months

Phase II: up to $2,000,000 for up to 2 years

Proposals that exceed the budget or project duration listed above may not be funded.

Summary

Many clinical guidelines rely on Primary Care Providers (PCPs) to assess cancer risk and provide recommendations. For example, the US Preventive Services Task Force (USPSTF) recommends that patients who are concerned about their breast/ovarian cancer risk seek guidance from their PCPs. To date, recognition of some cancer risk factors and incorporation of cancer prevention beyond routine screening, vaccinations, and behavior modification within the primary care workflow has been limited, in part due to time constraints, workflow integration, cognitive overload, and inadequate or delayed communication with patients or with specialists, leaving a missed opportunity for cancer prevention. Thus, there is an unmet need for evidence-based cancer prevention guidelines, cancer risk assessment tools, and recommendations for cancer prevention interventions to be better integrated within the primary care workflow. This is particularly necessary in the case of clinical practices not associated with, or regions without access to, high-risk clinics. A cancer prevention-focused digital platform (including genetic and other risk assessment tools as well as information on oral and locally delivered risk-reducing agents) is needed to help PCPs evaluate a patient’s cancer risk, be informed of clinical guidelines and recommendations related to these cancer risks and comprehend and evaluate the benefits and risks of applicable cancer preventive interventions. Developing a digital solution that can be seamlessly integrated within an already existing clinical management workflow will provide the resources and support to help PCPs become more proficient with cancer risk assessments and preventive recommendations, without additional time/resource burdens.

Project Goals

The overall goal of this solicitation is to develop a digital platform that provides PCPs with validated cancer risk assessment tools, cancer prevention guidelines, and clinical recommendations based on a patient’s risk factors to discuss with their patients. This technology will compile evidence-based tools/guidelines/recommendations related to cancer prevention for multiple cancer types, beyond routine screening and behavioral interventions, into a centralized platform that can be readily integrated within routine primary care workflows so that they do not provide an additional burden on PCPs given the time constraints of clinical management. For example, if a patient with a DCIS diagnosis sees their PCP for clinical management, the PCP could use the digital platform to review risk factors and guideline recommendations with the patient to determine possible management plans for breast cancer prevention.

The proposed technology should: be designed for updates as new/updated clinical guidelines are released; return cancer risk assessments and facilitate communication of clinical recommendations from PCPs to their patients in real-time as necessary; include information and resources related to a wide scope of cancer preventive interventions; include a provider-facing interface to run risk assessments, review clinical guidelines based on these assessments, and facilitate communication and shared decision making based on the recommendations; include a patient-facing interface with simplified language for patients to input their personal and family history and other risk factors, to provide the necessary information for risk assessment. The patient-facing interface should not provide access to risk assessments or clinical recommendations; this information will be communicated by PCPs. The proposed digital platform should use simplified language to assist with provider communication and facilitate patient comprehension and engagement for shared decision making. Development of the digital platform should incorporate input from both providers and patients from various types of healthcare communities (e.g., academic, community, etc.) and minority and rural populations, to ensure equitable ease of use and uptake.

Activities not responsive to announcement:

Platforms that cannot integrate with Electronic Health Records (EHR), platforms focused on a single cancer type, and platforms that do not incorporate a broader scope of cancer prevention (e.g., technology only focused on screening, vaccines, and behavioral interventions) will not be considered responsive to this solicitation.

Phase I Activities and Deliverables:

The goal of Phase I is to develop a digital technology that integrates cancer prevention guidelines, cancer risk assessment tools, and applicability of cancer prevention interventions.

Activities:

Establish a project team with expertise in digital healthcare platforms/EHR, cancer prevention and primary care, software development, user-centric design, patient navigation/engagement as appropriate for this proposed project.
Complete a systematic review to compile and assess current cancer prevention guidelines and recommendations for multiple cancer types beyond routine screening, vaccines, and behavioral interventions, to include supplemental screening, risk-stratified screening, personal and family history, genetic testing referral and results, ancestry, epidemiologic risk factors, available risk assessment tools, and recommendations from applicable organizations such as the National Comprehensive Cancer Network (NCCN), the USPSTF, and the American Cancer Society (ACS).
Engage stakeholders and determine clinical consensus in cases of differing recommendations or insufficient data.
Develop a pilot digital platform that incorporates the compiled research into a tool that PCPs can efficiently use to assess their patients’ cancer risks, and effectively communicate these risks and evidence-supported preventive recommendations to their patients.
Include a patient-facing interface for data collection within the digital platform.
Include the ability to continuously incorporate new information on cancer risk assessment and recommendations as it is released by the appropriate organizations.
Ensure privacy protection as required by law.
Identify at least two clinical settings, including a community-based clinic, where the digital platform may be used and integrated within a primary care practice for pilot user testing.
Test the feasibility/usability of the digital platform in a sample population of at least 25 PCPs and patients.
Test the feasibility of the digital platform within an EHR testing environment.

Deliverables:

A report of the compiled research on cancer prevention including resources/recommendations/guidelines that were incorporated into the technology.
Pilot technology design.
Demonstration of technology feasibility and acceptability by PCPs and patients, including in a community setting.
Technical specifications, including privacy and security protections, as well as an operations/user guide.
Outline of metrics that can be used to assess the successful application of the technology.

Phase II Activities and Deliverables:

The goal of Phase II is to implement the digital technology within EHR systems and evaluate its application in primary care settings.

Activities:

Develop a plan to implement the digital platform in EHR systems in primary care practice settings, including community clinics.
Enhance systems interoperability for deployment of digital platform in diverse software environments and provider networks.
Develop metrics to demonstrate successful use of the digital platform, including comprehension of the information by PCPs primary care providers and by the patients as communicated by their providers.
Conduct a validation study of the feasibility/acceptability and successful use of the digital platform in an additional population of at least 100 PCPs and patients.
Prepare a web-based course for training PCPs and patients on the intended use of the digital platform.
Develop a dissemination plan for the digital platform and the training course.
Develop a plan for commercialization of the digital platform.

Deliverables:

Letter(s) of commercial interest provided to the project and contract officers in the first year of the Phase II contract.
Validation of technology feasibility, acceptability, and successful use by PCPs and patients, including in a community setting.
Report with metrics demonstrating that PCPs comprehend the information within the technology and that patients understand the information as communicated by their providers. Report should also include analysis from discussions with participating providers and patients to better understand and improve the acceptability of the technology more broadly.
Finalized user guide and operations manual for use of technology within a range of primary care settings, including community clinics. These documents will include technical specifications, process guides/flow charts for how and by whom the technology will be used, and privacy and security protections.
Finalized troubleshooting guide as well as frequently asked questions.
Letter(s) of commercial commitment provided to the project and contract officer.

Receipt date: November 4, 2022, 5:00 p.m. Eastern Daylight Time

Apply for this topic on the Contract Proposal Submission (eCPS) website.

For full PHS2023-1 Contract Solicitation, c lick here.