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Empowering the Participant Voice

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Overview

See upcoming presentations and project updates on EVENTS tab.

What is the project about?

Investigators, ethics boards, research managers and coordinators are all enthusiastic about receiving research participant feedback, and participants are usually eager to provide their perspectives. Yet, common barriers to collecting feedback exist in many settings, and this feedback goes largely uncollected. Common challenges include finding the right tool, access to infrastructure for sending surveys and tracking metadata, effort (people), training, and resources to get the job done, and analysis tools and benchmarks to make sense of the data. Further, there is a broad group of other stakeholders who are interested in the collection, and sharing of such feedback, and could inform the best ways to respond to findings.

This project will create the infrastructure to streamline collecting research participant feedback and to generate the framework for benchmarking within and between institutions, to improve research.

The goal of the EPV multi-institutional project is to DEVELOP (Aim 1 for more) and share easy-to-use infrastructure that streamlines the routine collection of feedback from research participants about their experiences in clinical research, to inform the improvement of research. The project builds upon a validated RPPS participant-experience survey, and a low-cost easy-to-use platform (REDCap) already in wide use.  The project is designed to overcome barriers to using the RPPS that institutions have faced previously when thinking about collecting feedback.

Through collaboration across six Clinical and Translational Science Award sites (CTSAs), the team will engage institutional, community, and patient stakeholders as they develop tools, standards, focus on how to best reach different populations and how to make results valuable to different audiences.  Common standards for use of the tools and data within and across institutions, and the creation of data sharing agreements and aggregate databases will enable benchmarking and enable research toward tailoring how research is conducted to population preferences. The sits will implement a variety of use cases to DEMONSTRATE (Aim 2 for more) the utility and impact of the survey and infrastructure.  After refinement, the tools will be DISSEMINATED (Aim 3 for more) widely for to enhance representativeness and impact. The resulting data will help to identify better/best practices to improve research.

To execute the first Aim, the project team will Develop integrated tools incorporating the validated RPPS-Short in the REDCap platform with external modules to support project and program dashboards and analytics.  The project team will develop a set of standards for implementation and codify them into written guidance tools. 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. The project and deliverables will be visible to other stakeholders such as CTSA Consortium representatives, researchers and staff from other CTSA hubs, and other members of the REDCap user community as the project progresses to facilitate later uptake and dissemination. Aim 1 is due for completion in September 2021.
Update: Infrastructure developed (milestone April 2021), see JOINING EPV tab for links and a detailed Implementation Guide.
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.
Update: Dissemination is actively underway, see the JOINING EPV tab for links and a detailed Implementation Guide.

Why ask participants about their research experiences?

Research participants are critical to closing the gap or “translating” a scientific discovery from the laboratory into proven practices that improve health.  Clinical translational research cannot advance without research participants.

Many research studies enroll slowly or fail to ever enroll as many participants as are needed to answer a research question thereby stalling improvements to health.  For reasons of convenience, some studies may primarily enroll people with access to good healthcare; this may narrow the diversity of the study group and limit the generalizability of the results. For research discoveries to help those most affected by the disease under study, studies should include individuals from all the communities affected by the condition, and especially those affected by health disparities and otherwise under-represented in research.  The reasons for declining to join, joining, or leaving a research study may be complex and may differ for specific communities based on historical experiences, social or educational or other factors. Only by asking people about their experiences can we begin to tailor research to enhance those experiences.

Finally, and importantly, efforts to protect the rights, autonomy and safety of research participants result in many practices that are implemented in different ways, with little information about which way works best. Historically the adequacy of these protections has been judged by committees and institutions.

We believe that the effectiveness of practices designed on behalf of participants, should be judged, at least in part, by the experiences of the participants themselves.

Why survey research participants?

The most direct way to understand research participants’ experiences is to ask them.  Many new approaches intended to improve research engagement, recruitment and conduct have been implemented, yet, depending on how their effectiveness is measured, it can be difficult to know whether they will work in other populations or settings.  A validated survey provides quantitative measures that can be compared across groups, before, after, and across different approaches to decide which approaches are more effective in which populations.  Asking participants about their research experiences and using tools that produce measurable and comparable outcomes, provides essential data for improving the how clinical research is conducted and tailored to different populations.

The current lack of direct valid participant experience data to support evaluation of research practices and innovations, and guide their improvement, is a critical translational gap. This project is addresses the crucial need for data to improve clinical investigation.

Which survey?

The project uses the latest version of the Research Participant Perception Survey-Short-P. The survey includes experience rating questions that capture the key drivers of overall research experiences, demographics and study characteristics, questions about respect, listening, courtesy, partnership, motivation to leave, stay or return to research, and more. To read more about the journey developing the tools, read a lay summary or link to research publications.

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.


Contact Us

Rhonda G. Kost, M.D., Principal Investigator
The Rockefeller University Hospital
1230 York Ave.
New York, NY 10065