Rationale: Developing efficient and effective methods to recruit and screen participants for clinical research remains a major challenge for clinical discovery.

Traditional recruitment methods often involve building up large multi-site research networks and implementing cumbersome and resource-intensive screening processes that incur high fixed startup costs and delay timetables. These challenges hinder the scale and scope of otherwise worthy research questions and delay the production and application of clinical evidence to guide pressing clinical practice and policy questions.

Newer approaches have been developed to harness the broad reach, focused geographic targeting, and powerful economies of scale and efficiencies that are possible using direct-to-participant Internet recruitment. For example, we have recently implemented two studies, the WebTIA Project (completed) and a recruitment site for a stem cell trial for stroke (http://stemcellstudy.ucsf.edu, ongoing), and the CTSI’s Participant Recruitment Service has been working on delivering similar methods as a core service to accelerate the conduct of clinical research.

However, current Internet-based direct-to-participant methods have often been focused on the first step of identifying and targeting potential participants and matching them to potential studies, but less on how to effectively manage the volume of inquiries that these Internet-based efforts can generate.

For our most recent study recruitment website, we used an extensive online prescreening and eligibility process with participant-facing questionnaires to guide potential participants to self-report key eligibility-related questions. An automated algorithm then classified responses as concordant, discordant, or neutral for study eligibility in a way that accounted for differences in health literacy and for uncertainty in certain types of self-reported health information. This system allowed us to extend the capacity of research coordinators by prioritizing and focusing enrollment efforts on those individuals that may be most likely to meet final eligibility criteria and in ways that could be designed to prepopulate a study’s enrollment database after verification.

We believe that extending the Internet-based recruitment core currently under development through the CTSI Participant Recruitment Service with a robust and scalable pre-screening process would enhance the usefulness and potential for this recruitment method and would be the next key step toward the goal integrating pre-screening and enrollment activities with post-enrollment online clinical research tools.

Plan:

We propose to extend the Participant Recruitment Service’s Internet-based recruitment core by adding a self-reported pre-screening platform for a pilot study that provides:

1)    The ability to classify pre-screening responses as concordant, discordant, or neutral for study eligibility in a way that accounts for differences in health literacy and for uncertainty in self-reported health information.

2)    Dynamic online reports and readouts for study coordinators to help prioritize potential for eligibility validation and enrollment.

3)    Integration with post-enrollment research system to allowed for moving validated data elements to a study database.

Criteria and Metrics for Success:

Pilot Website Launch

# website hits

# primary prescreening forms initiated/completed

# who pass primary prescreening

# secondary prescreening forms initiated/completes

# enrolled from this source

% of overall recruitment goal

% prescreened/secondary screened/enrolled meeting diversity criteria

cost per enrollee

Total Budget: $33,810

$33,810 (12 months) - 5% FTE for PI; 7.5% FTE of the PRS Technical Recruitment Specialist; 5% FTE of the Marketing and Outreach Coordinator; Website Design and Programming

Collaborators:

Anthony Kim, Neurology

Nariman Nasser, Director CTSI Participant Recruitment Service