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

2. CCTSI Organizational Structure

3. Specific Aims
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

4. 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

5. 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.

6. 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.

7. 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

8. 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.”

9. 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.”

10. Summary of Recommendations
Develop and test the research readiness training and associated business model discovered though
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.

11. 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

13. 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

14. 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

15. Overview and Timeline

16. 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

17. 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)

18. 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

19. 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

20. 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?