An interventional study of Intervention in Colorectal Cancer, Breast Cancer and Coronary Heart Disease, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-28.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Prevention
We evaluated whether collection of risk factors to generate an electronic health record (EHR)-linked personalized health risk appraisal (HRA) for coronary heart disease (CHD), diabetes, breast and colorectal cancer (CRC) was associated with improved patient-provider communication, risk assessment, and breast cancer screening plans in the next year.
Growing evidence and understanding of an inherited component to several common, chronic diseases has led to an increase in the importance of information about family health history, and the integration of this information with other risk factors for common diseases, like lifestyle risk factors. The US Preventive Services Task Force (USPSTF) recommends the use of family health history as a routine genetic screening test for common diseases, as obtaining a complete family health history is the first step to identifying patients who are in need of intervention (e.g., intensive screening, lifestyle modification, preventative therapies, genetic counseling). The importance of integrating family health history with an individual's medical record will increase as our understanding of the genome evolves because it will be more essential to put detailed personal genetic information into a clinical context. Because of limited time during a typical primary care visit, and the concerns of primary care providers (PCPs) about their self-efficacy of estimating and providing guidance about risk, PCPs frequently do not obtain a family health history or provide individualized risk assessment. These issues highlight the need to leverage technology to collect these data independent of clinic visits, yet have these data interoperate with an individual's electronic health record (EHR). Telephonic interactive voice response systems (IVRS) and self-administered web-based tools are a low-cost, sustainable way of reaching out to primary care populations, independent of a visit. We propose to develop, implement, and evaluate a patient-reported, EHR-integrated personalized risk assessment module to provide tailored disease risk and risk reduction information.
The Specific Aims of the proposed project are to: Aim 1: Develop a patient-reported, EHR-integrated, personalized risk assessment module to provide tailored disease risk and risk reduction information for four common diseases (breast cancer, colorectal cancer, coronary heart disease, and type II diabetes) for the patient and his/ her PCP. Aim 2: Measure the reach and effectiveness of this integrated risk assessment module by conducting a cluster randomized controlled trial (RCT) of adult primary care patients in the Brigham and Women's Primary Care Practice-Based Research Network. Aim 3: Evaluate facilitators and barriers to the adoption and implementation of this integrated risk assessment module.
This project will further our understanding of how technology can be used to fill a gap in current clinical practice by facilitating the systematic collection of family health history and lifestyle risk factor data and integrating these data with an individual's EHR to personalize care in a variety of settings and for diverse patient populations. This work will use current national data standards for interoperability, and lessons learned from this project will be exportable to healthcare settings throughout the United States.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 6,075 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria
The intervention is completion of a validated, web-based risk assessment used to assess personalized risk and generate a risk report
Other: Intervention
Usual Care
risk assessment survey; decision support for providers for prevention based on risk
Also known as: Risk Assessment and Prevention Recommendations
Number of Subjects Who Discussed Disease Risk With Primary Care Provider
Time frame: 3 months following primary care visit
| Milestone | Intervention | Control |
|---|---|---|
| Started | 2699 | 3376 |
| Completed | 1699 | 2004 |
| Not completed | 1000 | 1372 |
| Participants | Intervention | Control |
|---|---|---|
| Number of Subjects Who Discussed Disease Risk With Primary Care Provider | 905 | 841 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/1,699 (0%) | 0/1,699 (0%) | 0/1,699 (0%) |
| Control | 0/2,004 (0%) | 0/2,004 (0%) | 0/2,004 (0%) |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Median | 55 (18 to 75) | 56 (18 to 75) | 55 (18 to 75) |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 1338 | 1415 | 2753 |
| Male | 361 | 589 | 950 |
| Race/Ethnicity, Customized(participants) | Intervention | Control | Total |
|---|---|---|---|
| white | 1418 | 1675 | 3093 |
| black | 79 | 82 | 161 |
| Latino | 91 | 105 | 196 |
| Other/ unknown | 111 | 142 | 253 |
| Region of Enrollment(participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 1699 | 2004 | 3703 |
Plan to share: No
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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