Hub Research Capacity Integrating Special Populations Wendy Kohrt, PhD Associate Directors

CCTSI Organizational Structure

Specific Aims 2018-2023 Aim 1 Ensure that infants, children, and adolescents continue to be an important focus of CTR within the CCTSI by supporting research on both common and rare diseases. 1.1 Engage communities and Patient Advocacy Groups as research partners to assist with study design and patient recruitment and to enhance the dissemination of research findings 1.2 Catalyze innovative pediatric research through the CMH pilot grant program, including at least one annual award that targets early origins of chronic disease, and networking events

Specific Aims 2018-2023 Aim 2 Evaluate and promote the appropriate inclusion of older adults in CTR 2.1 Utilize the Clinical Research Management System (OnCore) to track the intent to include older adults in research (targeted age range, 60+ y) and evaluate enrollment success rates 2.2 Support research networks focused on improving care for the most vulnerable segments of the aged population, including those who are terminally ill and those in long- term care facilities

Specific Aims 2018-2023 Aim 3 Develop a standardized approach for monitoring recruitment success in CTR protocols and strategies to enhance the inclusion of underrepresented minorities (URMs). 3.1 Utilize OnCore to define target populations, capture accrual rates and facilitate standardized reporting on the enrollment and retention of research volunteers, including URMs. 3.2 Expand local resources and technology to assist investigators with recruitment of volunteers for CTR, including hard to reach populations (e.g., culturally sensitive mechanisms, tele-technology)

Accomplishments Aim 1 Ensure that infants, children, and adolescents continue to be an important focus of CTR within the CCTSI by supporting research on both common and rare diseases The 2018 CCTSI Summit was focused on Lifespan Research: From Pregnancy through Aging. It facilitated interactions among investigators across campuses and highlighted available resources to support lifespan research. Recruitment of children and the elderly will be facilitated by new policies at UCH and CHCO (release to be contacted for research at clinical appointments) The CMH pilot project program funded 4 mentored pilot projects and 1 junior faculty project in 2018, including 2 on early origins of disease: Placental Transport of Fatty Acids in Intrauterine Growth Restriction Humoral Immune Development in the First Year of Life

Accomplishments Aim 2 Evaluate and promote the appropriate inclusion of older adults in CTR OnCore is not yet being used to track the plan to enroll older adults in research or the success in meeting enrollment targets. OnCore implementation, including integration with UCH Epic for billing, is ongoing. The expected completion date for full integration of OnCore and Epic functionality at UCH is 2019. All protocols that have UCH billing and all that use the CTRC must use OnCore. A request has been submitted to the IRB to eliminate the requirement that protocols include an upper age limit as an eligibility criterion. The plans to support research networks focused on improving care for the most vulnerable segments of the aged population have not yet been implemented. The VA GRECC developed Older Veterans Engagement Teams (OVET) to guide the development of research studies for older Veterans. The plan is to expand this to non-VA research.

Accomplishments Aim 3 Develop a standardized approach for monitoring recruitment success in CTR protocols and strategies to enhance the inclusion of URMs OnCore is not yet being used to track the inclusion of URMs in research. The Study Information Portal module of OnCore has been implemented and studies open to enrollment are posted on the School of Medicine website. Expansion of resources and technology to help investigators engage the ‘hard to reach’ in research has not yet occurred. The relocation of the CTRC to the new facility may support new technologies (e.g., telehealth).

Response to EAC Critiques “Consider engaging the community to aid faculty in research awareness and recruitment efforts” First steps in this direction for clinical research have been taken by VA investigators. If successful, the OVET model can be expanded. “Consider using Epic and direct patient recruitment through MyChart” UCH and CHCO now have opt-out mechanisms for patients who do not want to be contacted about research opportunities. Compass can now be used to identify and contact potential research volunteers.

Response to EAC Critiques “Consider tracking the connections generated by the PAGs and from the CU-CSU Summit as a way of measuring success” Summit evaluations ask about new connections immediately after the event, but longer-term follow-up may be lacking.

Questions for EAC What strategies are other CTSAs using to promote and track appropriate enrollment of volunteers across the lifespan in research?