Quality and Process Improvement Program (QPIP) Bethany Kwan, PhD, MSPH Director, QPIP

CCTSI Organizational Structure

Specific Aims 2018-2023 Continue to undertake quality and process improvement activities to ensure efficiency and sustainability of the CCTSI Collaborate with the CCTSI Dissemination Core to optimize processes for internal and external dissemination of CCTSI innovations

Accomplishments Community Engagement sustainability plan Value propositions, business model, and opportunities for improvement Collaboration with community engagement Process planning for new CAR-T cell therapy translational research on campus Collaboration with regulatory support Clinical trials recruitment infrastructure Collaboration with regulatory support, I-Corps, and dissemination and implementation

Community Engagement Sustainability Plan Objectives To assess current programs, resources and user experiences within the University of Colorado CCTSI Community Engagement core (CE). To make recommendations for improvement based on user and staff experiences To facilitate decision making by process owner and other stakeholders regarding design and implementation of optimized CE resources and an improved value proposition.

Methods Established a logic model focused on enhancing the reputation, value, coordination, quality, rigor, and sustainability of the CE core using a customer discovery methodology. In collaboration with a workgroup of PACT Council representatives and Community Research Liaisons, drafted value propositions for the CE core education and training, grant funding, and consultation programs and services for investigators and community organizations. In conjunction with participation in the CCTSI I-Corps program, tested and refined value propositions and a revenue generation plan using customer discovery interviews with 28 investigators and community representatives.

Themes Opportunities to concentrate resources on enhancing and expanding high-value programs and services Opportunities to protect reputation and community-academic relationships Opportunities to re-evaluate the mission and objectives of the PACT Council Opportunities to generate revenue and enhance sustainability through “research readiness” training

Core Value Proposition:   “For investigators seeking to engage communities, patients and other stakeholders as research partners, the CCTSI Community Engagement Core offers access to a network of community based organizations that have been trained in “research readiness”, which facilitates the effective and efficient engagement of patients and community members for the purpose of informing the design, conduct and dissemination of research studies.”

Additional Value Propositions “For investigators seeking to improve relevance and impact of their research on health the CCTSI community engagement education and training portfolio offers practical skills building and access to a network of like-minded professionals and community liaisons to make research meaningful to stakeholders and rewarding for investigators.” “For investigators seeking to establish a line of funded community-oriented research the CCTSI community engagement grants provide funding, training and coaching to support partnership development and community engaged research activities, setting investigators on a path to long-term success in their work with patients, communities and funders.” “For investigators seeking to engage communities in research CCTSI community consults provide personalized recommendations from experts with broad experience in engagement, flexibly addressing different types of investigator need, more efficiently than having conversations with multiple groups.”

Summary of Recommendations   Develop and test the research readiness training and associated business model discovered though ICorps@CCTSI. Develop and implement complementary programming for CIT and pilot and partnership development funding to guide investigators in the methods and principles of longitudinal community engagement, to ensure follow-up and follow-through to protect university reputation and community relationships. Share value propositions with university leadership and request infrastructure support from the Chancellor’s office for a centralized office of community and stakeholder engagement on the Anschutz campus. As new PACT Council members join in Fall 2018, establish a mission and objectives for the PACT Council that focus on implementing and ensuring accountability for the QPIP recommendations.

Process Planning for Cell Therapy Translational Research Regulatory Support requested assistance with process mapping for the full life cycle of new cell therapy translational research on campus Development, approval, apheresis, transport, manufacturing, infusion, monitoring, and data capture Conducted process interviews with key stakeholders Study team, clinical teams, regulatory compliance, cancer center, manufacturer

Clinical Trials Recruitment Infrastructure Regulatory Support requested assistance with process mapping for the full life cycle of new cell therapy translational research on campus Development, approval, apheresis, transport, manufacturing, infusion, monitoring, and data capture Conducted process interviews with key stakeholders Study team, clinical teams, regulatory compliance, cancer center, manufacturer

Clinical Trials Recruitment Infrastructure Current status Clinical trials recruitment currently relies upon the variable resources and processes of the individual investigator and study team Objective Design a centralized, systematic, efficient process and infrastructure for clinical trials recruitment

Overview and Timeline

Clinical Trials Recruitment – QPIP Activities Establish improvement objectives Identify process owners Develop a logic model Engage stakeholders Identify specific opportunities for improvement Recommend processes and systems needed for implementation

Clinical Trials Recruitment – Logic Model Excerpt Assumptions Inputs Activities Outputs Outcomes Impact Centralized/Accessible recruitment/retention services and assistance are valued by: Investigators, the Institution, business and industry, funding agencies, hospitals, patients/participants. Assessment of other institutions’ Clinical Trials Recruitment services and resources. Customer discovery (I-Corps) Investigator toolkit and centralized resource integration of existing services and resources - including access to EMR for feasibility and recruitment, understanding available participant pool for my study type (and typical research participation rate). Increased research subject recruitment AND retention rates (accrual rate and acrual completion; increased screening) Improved institutional reputation to complete clinical research (PIs, Industry, Institutional Leadership, Funders)

New Governance Structure Director of QPIP Bethany Kwan, PhD, MSPH Assistant Professor, Department of Family Medicine Social psychologist, dissemination and implementation scientist Investigator and Education program lead, Adult & Child Consortium for Health Outcomes Research & Delivery Science Dissemination lead, CU Data Science to Patient Value initiative CCTSI Director Ronald Sokol CCTSI Admin. Core Admin. Director Tim Lockie QPIP Director Bethany Kwan QPIP Team Dan Holtrop Drew Sayer

Response to EAC Critiques “Maintain capacity to take “deep dives” into areas of concern as they arise” QPIP remains focused on high-priority areas of need within the CCTSI “Pursue collaboration with the dissemination core to share QPIP ideas and approaches with teams across campus and CTSA hubs” Dr. Kwan now also serves as Associate Director for CCTSI Dissemination Currently collaborating on clinical trials recruitment infrastructure project

Questions for EAC What opportunities for dissemination of QPIP work might exist across CTSAs? What might be of value outside our institution? Who would be the audience? What mechanisms for dissemination are recommended?