The RISC Registry--Risk Informed Screening Registry
Study Details
Study Description
Brief Summary
The RISC Registry is an observational study that seeks to understand the application of risk-informed screening and care approaches and pursue the hypothesis that these screening approaches accompanied by population appropriate methods of clinician and patient engagement may increase understanding and compliance with screening, surveillance and follow up recommendations by empowering people to make healthier choices, and support addressing disparities in screening and patient care.
The primary focus is cancer screening. The study will start by focusing on women and breast cancer risk.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The RISC Registry (the "Registry" ) is a longitudinal observational database designed to capture health information to help develop individualized disease risk and care plans in varied patient populations and study how that information impacts physician recommendations and patient compliance.
The Registry was designed by a board of Scientific Advisors who are active users of risk assessment tools, and risk-informed screening protocols, including physicians, nurses, and patient advocates. Technology professionals and site administrators were also consulted regarding optimizing the process of data collection and dissemination. The Registry uses widely accepted standards for risk and disease classifications, results, management, and validated quality-of-life measures.
The Registry is vendor-agnostic and product-agnostic.
The RISC Registry will help determine the ongoing value of Precision Screening (Precision cancer screening attempts to separate those who will benefit from screening from those who will not, through use of information on disease risk) in different clinical patient populations, shape guidelines for screening and optimal patient management, and support improvements in Precision Health and Precision Medicine support technology.
Study Design
Outcome Measures
Primary Outcome Measures
- Clinician: Types of clinical management recommendations made based on the risk assessment and care plan options [Within 1 month]
Types of recommendations may include mammography or other types of imaging, frequency of imaging, other types of tests to assess risk
- Clinician: % of time clinician recommendations were made and/or changed based on the different risk model information presented [Within 1 month]
Changes to recommendations based on new risk informed assessments
- PRO--Patient Reported Outcomes: % of time patient screening behaviors changed based on recommendations made by shared decision making with the clinician [Within 3 months]
Patient behavior correlated with recommendations
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female (Gender assigned at birth)
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Unaffected women--have never had breast cancer
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Females who have been diagnosed with breast cancer
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Females who are presenting for cancer screening
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Ages 18+
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Willing to sign a study consent form
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Willing to participate in PRO surveys
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Willing to use technology to participate in the study procedures , if and as needed
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PHEI--Precision Health Equity Initiative | Palo Alto | California | United States | 94301 |
Sponsors and Collaborators
- Precision Health Equity Initiative
Investigators
- Principal Investigator: Rakesh Patel, MD, Precision Health Equity Initiative
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RISC 1.0