Doxy.me Inc. — Department of Health and Human Services STTR Phase I: NLM

Description

Lack of recruitment of qualified research participants into clinical trials remains to be one of the most important issues in clinical research Studies often struggle to meet recruitment goals on time resulting in costly time extensions underpowered results and in some cases early termination Many reasons attribute to suboptimal recruitment including the challenges related to informing and consenting potential research participants Informed consent is a laborious but essential process involving trained research personnel meeting face to face with participants which can be especially challenging during busy clinic schedules or recruitment at remote locations While new electronic consents e consents are overcoming challenges related to readability and management of paper based consents they do not adequately address access challenges Informaticists at the Medical University of South Carolina MUSC have developed an innovative informed consent approach that leverages telemedicine technology This novel approach called teleconsent allows research personnel to meet and discuss the study with a prospective participant virtually using a video feed share an informed consent document that can be collaboratively filled out by participant and personnel in real time and generate an electronically signed informed consent which is available for immediate download or print by both parties This process can eliminate the hassles related to travel and management of personnel at remote sites Furthermore with the introduction of video the researcher can visually assess potential participants when determining capacity to consent and build rapport with the enrollee to enhance retention Teleconsent has been successfully implemented in several clinical trials at MUSC and elsewhere however since making teleconsent technology available many researchers and organizations have described unique needs that the current teleconsent technology does not adequately support mobile devices and creating teleconsent documents While the current teleconsent technology meets the needs of many researchers and organizations further work is required to enhance teleconsent to meet the diverse needs in research and improve the effectiveness of clinical trial recruitment The objective of this proposal is to expand and improve teleconsent to better meet the unique needs of research organizations and research participants To accomplish this we will use key informant interviews to better understand user needs and desires for proposed teleconsent enhancements Aim and use formal usability methodologies to iteratively develop and evaluate prototypes of proposed teleconsent enhancements Aim Achieving these aims will allow us to development and implement these enhancements in STTR Phase II Doing so we can increase research recruitment and informed consent by making the process easier and more convenient for participants using expanded telemedicine capabilities Obtaining informed consent is an essential yet challenging aspects of clinical research Teleconsent is a telemedicine inspired solution developed to make the informed consent process easier and more accessible This project will explore and iteratively design innovative teleconsent enhancements to address unique research needs and workflows By making informed consent easier and more accessible clinical research can be more efficient