U01 to Rockefeller Supports Multi-CTSA Collaboration to Empower the Participant Voice

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In May, the National Center for Accelerating Clinical Translational Science (NCATS) granted a $2.7 Million award to Rockefeller University to develop new infrastructure facilitating collection of research participant feedback for widespread adoption: “Empowering the Participant Voice: Collaborative Infrastructure and Validated Tools for Collecting Participant Feedback to Improve the Clinical Research Enterprise (PAR-19-099, 1-U01-TR003206). Principal investigator Dr. Rhonda G. Kost, Co-Director of Community Engagement, and Associate Professor in the Center for Clinical Translational Science (CCTS), will lead a 6-site collaboration including Duke, Vanderbilt, Johns Hopkins, Wake Forest, and University of Rochester to leverage the validated Research Participant Perception Survey (RPPS) into a new low-friction REDCap based platform. Dr. Roger Vaughan, head of biostatistics at the Rockefeller CCTS, will collaborate on project evaluation and to incorporate analysis tools into the platform. Dr. Paul Harris (Vanderbilt) will lead the informatics component of the project. Widespread utilization of REDCap within and beyond the Consortium will help to accelerate uptake. Flexible implementation of the participant survey coupled with standardization of data elements, and an analytics dashboard, will streamline the ability to collect participant feedback, benchmark within and between institutions, and use actionable data to enhance research.

Why survey research participants? Partnering with patients and research participants -- including those from communities affected by health disparities or under-represented in research -- is essential to clinical translational research. Recruitment, retention, and representative sampling remain major challenges to the research enterprise. Assessing participants’ research experiences provides essential outcome data for improving the clinical research enterprise and tailoring approaches to different populations. The paucity of direct participant experience data to support evaluation of research practices and innovations, is a critical translational gap. This grant is addresses this crucial need to improve clinical investigation.

Where to begin? This project builds on more than a decade of work developing and testing a Research Participant Perception Survey (RPPS) to standardize assessment. A suite of validated long, short and ultrashort RPPS surveys were developed and are available free of charge for non-commercial use.

What is the project about? Investigators, institutional review boards, investigators and coordinators are enthusiastic about receiving participant feedback, and participants are eager to provide their perspectives. Yet, common barriers to collecting feedback exist in many settings and generally converge on finding the right tool, and access to infrastructure, resources, training, and analysis tools. This project will create the infrastructure to streamline collecting participant feedback.

How will the project proceed? To execute the first Aim, the team will Develop integrated tools incorporating the validated RPPS-Short in the REDCap platform with dashboard and analytics external modules and formalize the implementation framework into written guidance. The standards will afford institutions flexibility in their execution of the second aim, implementation of the infrastructure, while preserving common data elements to enable intra- and inter-institutional data integration and benchmarking. Each site will engage local stakeholders -- including institutional leadership, human research protections professionals, research mangers, investigators, coordinators, participants, patients, and communities – early and often to build support and excitement among stakeholders and plan implementation to address concerns and priorities.

To execute the second Aim, sites will Demonstrate the utility and effectiveness of the infrastructure by implementing local use cases – study-level surveys, departmental aggregation of project surveys, and institutional level surveys – that reflect local priorities and reach different populations. Sites will use a variety of outreach platforms and implementation approaches to reach participants through email, social media, patient portals and other platforms depending on local priorities, resources and preferences. The use cases will demonstrate the flexibility, usability and value of the RPPS/REDCap infrastructure, and provide feedback for refinement of the infrastructure and tools. Among the project deliverables are the examples of effective implementation, and actionable findings gleaned from participant feedback that institutions then use to drive measurable improvements to research experiences.

To execute the third aim, in Years 3 and 4 the team will actively Disseminate the infrastructure across the REDCap user community and CTSA Consortium hubs. The value proposition for different stakeholders – investigators, clinical research managers, department and institutional leadership, and NCATS – will be refined in streamlining the path to widespread use. intra-institutional use of the tools will return value to a breadth of stakeholders at each institution and its communities. Broad dissemination to a critical mass of users could also support valid inter-institutional benchmarking which has long been a goal of the initiative.

Defining Success

The ultimate measures of the success of the project will be the creation of the RPPS/REDCap project tools, and infrastructure, outcome data from completed demonstration projects that illustrate the effectiveness of the tool to collect feedback from representative populations, and identify actionable findings to spark impactful improvements. Other metrics include the uptake of the new infrastructure and approach by Consortium members and REDCap users, and their participation in both intra-institutional and Consortium-wide benchmarking. The goal is to provide value to a range of stakeholders, enabling broad use of participant feedback to improve research.

The RPPS/REDCap project is also supported in part by an award to Rockefeller University from the National Center for Accelerating Translational Science, 1U TR0001866.

To read another article about the grant

To read about the RPPS tools at Rockefeller

Project team:

The Rockefeller University

Rhonda G. Kost M.D., Project PI

Roger Vaughan Ph.D

Cameron Coffran M.A.

Dozene Guishard M.Ed., Community member< Carter Burden Network

Duke University

Ranee Chatterjee Montgomery, M.D., MPH, Site PI

Schuyler Jones, M.D. 

Kelly Keefe MHA

Jamie Roberts MPH, M.A.

Johns Hopkins University 

Daniel Ford M.D. MPH., Site PI

Liz Martinez RN, BSN

Cassie Lewis-Land M.A.

University of Rochester

Ann Dozier PhD, Site PI

Carrie Dykes PhD

Cody Gardner MBA

Vanderbilt University

Paul Harris Ph.D. Site PI 

Alex Cheng Ph.D.

Wake Forest University

Joe Andrews M.D., Site PI

Lynne Wagenknecht DrPh

Issis Kelly-Pumarol M.D.

Publishing CTSA Program Hub’s Name
CTSA Program In Action Goals
Goal 2: Engage Patients and Communities in Every Phase of the Translational Process