Quality and Process Improvement Program (QPIP)

1. Quality and Process Improvement Program(QPIP) David R. West, PhD Member, CCTSI Executive Committee Professor of Family Medicine

2. Specific AimsReview • Aim 1: Identify and remove obstacles to efficiency and process improvement in priority areas • Aim 2: Form clearly identified and empowered process improvement teams • Aim 3: Link with evaluators to ensure efforts are complementary rather than redundant • Aim 4: Integrate quality and process improvement into CCTSI governance and decision-making structures

3. Goals • Efficient use of resources, streamline processes and eliminate waste • Elimination of unnecessary variation to maintain the high-quality and client-centered delivery of services and support • Achieve cost-savings that can be reinvested in mission-critical aspects of the infrastructure and environment for CTR.

4. QPIP Team

5. Year 1: Three Priority Areas • Clinical Research Support Center (CRSC): Assist the CRSC to develop and implement work flows and support for pre-study approval and ongoing compliance • Regulatory Approval: Assist with developing processes for the incorporation of regulatory compliance into grant/project planning • Subject Recruitment/Retention: Developing, disseminating, and putting into practice clear processes for identifying, engaging, enrolling, and retaining research subjects

6. A Word About Quality and Process Improvement • Requires fidelity to stakeholder ownership • Must follow a structured process to: • Define scope (Logic model) • Define Timeline and End Points (Project Plan) • Engage process owners and stakeholders • Fully understand current processes to be “improved” (process mapping) • Process Owners publically espouse process revisions (not the QPIP team) • Formal implementation and rapid cycle revision/improvement • Accountability to Sponsor (Exec. Committee and PI)

7. Progress, To Date • Project Scope Via Logic Model • Detailed Process Maps and Workflow and Gap Analysis of Interrelated Processes: • CHCO • University of Colorado Hospital • CCTSI/SARC • University of Colorado

9. Key Issues to Resolve • Investigator Confusion: What you prepare and the help/advice you get are often a factor of what door you walk in – if you walk in at all • Investigator Frustration: Double/triple handling of similar data, requiring faculty and staff to provide the same data to multiple review groups/ multiple times • Hospital exposure and cost • Process delays/sequencing issues • Updating mechanisms sketchy • Some surprises/holes to fix

10. Process Map

11. Some Bumps in the Road • Process Improvement Delay – NOGA • Turnover within organizations • Priority and scope drift • Overtaken by other events • But – the urgent need to do this remains

12. Questions for EAC • Regaining consensus amongst stakeholder organizations a priority. EAC input on this process? • Containing future project drift: Possible strategies to maintain momentum through completion • Rapid cycle iterative implementation – Input into a mixed methods evaluative approach and possible metrics beyond cycle time, investigator knowledge, investigator satisfaction? Operationalizing cost and cost savings?