Breast Cancer, Colorectal Cancer, Coronary Heart Disease, Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERIntervention
risk assessment survey; decision support for providers for prevention based on risk
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults 18 - 75 Years old * English or Spanish speaking * Recent visit to a participating primary care practice
Exclusion criteria
* No phone number or email address listed in the EHR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects Who Discussed Disease Risk With Primary Care Provider | 3 months following primary care visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Risk Assessment and Prevention Recommendations provided to subjects | 1,699 |
| Control Usual Care | 2,004 |
| Total | 3,703 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 55 years | 56 years | 55 years |
| Race/Ethnicity, Customized black | 79 participants | 82 participants | 161 participants |
| Race/Ethnicity, Customized Latino | 91 participants | 105 participants | 196 participants |
| Race/Ethnicity, Customized Other/ unknown | 111 participants | 142 participants | 253 participants |
| Race/Ethnicity, Customized white | 1418 participants | 1675 participants | 3093 participants |
| Region of Enrollment United States | 1699 participants | 2004 participants | 3703 participants |
| Sex: Female, Male Female | 1338 Participants | 1415 Participants | 2753 Participants |
| Sex: Female, Male Male | 361 Participants | 589 Participants | 950 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,699 | 0 / 2,004 |
| other Total, other adverse events | 0 / 1,699 | 0 / 2,004 |
| serious Total, serious adverse events | 0 / 1,699 | 0 / 2,004 |
Outcome results
Primary
Number of Subjects Who Discussed Disease Risk With Primary Care Provider
Time frame: 3 months following primary care visit
Population: 1673+1847 (Total=3520) is the total number of subjects who answered the question that this outcome is derived from. (During your last doctor visit, did you talk to your PCP about your risk of developing cancer, heart disease or diabetes.) The total number of subjects included in the analysis is 3703.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Subjects Who Discussed Disease Risk With Primary Care Provider | 905 Participants |
| Control | Number of Subjects Who Discussed Disease Risk With Primary Care Provider | 841 Participants |