Introducing the Research Change Package: Improving IBD Research Together

Pediatric clinical trials face many barriers. They are too slow, too expensive and are often disconnected with the needs of the children and families they are supposed to help.

The Research Trailblazers – an ICN Learning Lab focused on improving pediatric clinical research – identified issues and barriers associated with participating in research studies and began to test and share strategies and best practices to close gaps related to successful trial enrollment, accelerating the pace of trial start-up, and developing more efficient processes across all phases of a research study.

A major accomplishment of this work is the information, knowledge and know-how collected in their Research Change Package - A Guide to Improving Your Research Journey.

The Story

Initially, the Research Trailblazers focused only on how to improve trial recruitment and enrollment efforts. Participating ICN sites (Riley Hospital and MassGeneral Hospital for Children) used LEAN methodology to develop process maps to illustrate how communications and information flow across their clinics to ultimately recruit patients into a research study. This exercise provided a better visualization of the processes and allowed the sites to recognize the complexity of their systems.

Using their process maps, the sites then identified opportunities for efficiencies and where they might test interventions that could improve their processes. Unfortunately, just as the sites began to see positive changes resulting from the interventions they were testing, COVID-19 changed everything.

While the sites adjusted their protocols and resources in response to the pandemic, the Research Trailblazers also adjusted their approach. The group pivoted away from testing interventions at local sites and instead refocused their efforts on pooling existing research best practices. Through interviews with and learnings from study teams, patients and families, investigators, and research coordinators, the trailblazers assembled the Research Change Package - a document designed to help sites develop and improve their research processes.

The Change Package

The Research Change Package identifies best practices, risks to watch out for, practical tips and Quality Improvement methodologies that can be used to better assess sites’ capacity to join a research study, to move through IRB and legal approvals more efficiently, to improve processes for identifying study eligible patients, and to increase recruitment. The change package organizes the information into the following sections and appendices:

Study Initiation

• Protocol Review
• Infrastructure Development
• IRB Process
• Contracting

Study Activities

• Coordinator Support
• Recruitment
• Communications Plan
• Measures and Dashboard
• Site Close Out

Appendices

• Study Feasibility Checklist Template
• Communication Flow Tracking Form
• Sample Communication Flow Case Study
• Sample RACI Matrix
• Sample Metrics Dashboard

The Research Trailblazers are pleased to share the Research Change Package and believe it will enable sites across ImproveCareNow – and beyond - to make real improvements to their research systems and capacity, resulting in more patient participation in meaningful and timely studies, and a better research experience for team members and participants.

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