The iOpen Platform utilized in this project is supported by ConduITS Institute for Translational Sciences CTSA at the Icahn School of Medicine at Mount Sinai (ISMMS).
On April 1, 2021, Guy Montgomery (PI) and colleagues received a new R01 award entitled, Enhancing the public health benefits of mammography screening by informing women of both breast cancer and breast arterial calcification results: A randomized trial to promote cardiovascular health. The project is just getting underway, and we will be working with Joseph Finkelstein, MD, PhD Chief Research Informatics Officer (CRIO) and Information Technology at ISMMS to develop an e-consent process (using the iOPEN platform) in both English and Spanish for the project. In the study we hope to recruit quite a large sample of women undergoing mammography for the first phase of the project (N=14,875), and an e-consent approach will be necessary to speed up the recruitment workflow while providing patients with truly informed consent.
Recent research indicates that standard digital mammography can yield information about the presence of calcifications within breast arteries – breast arterial calcification (BAC). The presence of BAC has been associated with calcification within coronary arteries, which is a marker of coronary artery disease (CAD). Research indicates that at least 12.7% of women’s mammograms reveal BAC – about 1 in 8. However, most BAC prevalence literature to date has been conducted on predominantly or exclusively white and non-Latina samples. To remedy this, a descriptive goal of the project is to describe BAC prevalence in a large, racially and diverse sample (N=14,875). To recruit this sample size with limited staff, an e-consent approach is necessary and we are excited to develop a new study-specific platform.
The primary goal of the project is to conduct an information-based randomized clinical trial to see if informing women of their BAC status will increase the likelihood of their attendance at a cardiovascular appointment (primary outcome), of engaging in heart healthy behavior, and of having CAD detected. The iOPEN platform will be used to consent patients to this RCT phase of the project as well. Overall, this will be the first study of an intervention to directly share BAC information with women undergoing mammography in a “direct to consumer” approach, and the first to report BAC prevalence in a racially and ethnically diverse sample, as such it is a first step towards ensuring that women benefit directly from all of the rich health data that mammography can yield.
ConduITS is supported by NCATS of the NIH’s CTSA Program. Any use of CTSA-supported resources requires citation of grant number UL1TR001433 awarded to ISMMS in the acknowledgment section of every publication resulting from this support. Adherence to the NIH Public Access Policy is also required.