A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Simple Architecture (Part 1)

Abstract

BackgroundThe ability to identify, screen, and enroll potential research participants in an efficient and timely manner is crucial to the success of clinical trials. In the age of the internet, researchers can be confronted with large numbers of people contacting the program, overwhelming study staff and frustrating potential participants.ObjectiveThis paper describes a “do-it-yourself” recruitment support framework (DIY-RSF) that uses tools readily available in many academic research settings to support remote participant recruitment, prescreening, enrollment, and management across multiple concurrent eHealth clinical trials.MethodsThis work was conducted in an academic research center focused on developing and evaluating behavioral intervention technologies. A needs assessment consisting of unstructured individual and group interviews was conducted to identify barriers to recruitment and important features for the new system.ResultsWe describe a practical and adaptable recruitment management architecture that used readily available software, such as REDCap (Research Electronic Data Capture) and standard statistical software (eg, SAS, R), to create an automated recruitment framework that supported prescreening potential participants, consent to join a research registry, triaging for management of multiple trials, capture of eligibility information for each phase of a recruitment pipeline, and staff management tools including monitoring of participant flow and task assignment/reassignment features. The DIY-RSF was launched in July 2015. As of July 2017, the DIY-RSF has supported the successful recruitment efforts for eight trials, producing 14,557 participant records in the referral tracking database and 5337 participants in the center research registry. The DIY-RSF has allowed for more efficient use of staff time and more rapid processing of potential applicants.ConclusionsUsing tools already supported at many academic institutions, we describe the architecture and utilization of an adaptable referral management framework to support recruitment for multiple concurrent clinical trials. The DIY-RSF can serve as a guide for leveraging common technologies to improve clinical trial recruitment procedures.

A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Identification of Efficient and Cost-Effective Methods for Decision Making (Part 2)

“…The data manager notified team members to increase or decrease recruitment efforts, particularly on digital strategies such as social media ads and research registry pulls. This is described in further detail in the study by Palac and colleagues [12] and was a critical and cost-efficient contributor to the success of the recruitment strategies described in this paper. As the data component of the framework described by Palac et al [12] was based on technologies already supported by our university (and commonly found at other universities), there were no additional technology costs to maintain this support system.…”

“…Using a variety of recruitment strategies is recommended, and the tools presented in Tables 6 and 7 are intended to help researchers determine the best subset of strategies to use for a particular study or set of studies. To efficiently manage multiple strategies, we recommend implementing a recruitment support framework as described by Palac et al [12], which is structured around an online screening survey and a central tracking database overseen by a data manager. To make decisions on initiating and maintaining different types of recruitment strategies, careful examination of the resources available (ie, budget, staff, relationships, and discounts) and requirements of the research study (ie, target recruitment number, target participant flow/timeline, and entry criteria) is essential.…”

“…During the recruitment period reported on in this paper, we conducted 3 trials for adults older than 18 years and 2 trials for targeted age groups (ie, high school students, adults aged 65 years and older), all of which evaluated eHealth interventions for the treatment or prevention of common mental health conditions (ie, depression, anxiety) and included a national recruitment strategy. The companion paper by Palac et al [12] also includes a trial that was conducted exclusively in the Chicago area.…”

“…The Center for Behavioral Intervention Technologies (CBITs) at Northwestern University recently completed enrollment for 5 simultaneous clinical trials of eHealth interventions for common mental health conditions (ie, depression and anxiety). To support this enrollment effort, CBITs developed a clinical trial recruitment support system [12] and a set of recruitment methods that were flexible to the target populations required for each of the trials. This paper presents descriptive information regarding the recruitment strategies employed by CBITs during a nationwide recruitment for eHealth clinical trials, the efficiency of these strategies in producing referred and enrolled participants, and the estimated cost of using these strategies.…”

“…The aim of this paper was to propose a decision framework for cost-effective trial recruitment. To support this aim, we describe a set of procedures that were used to recruit and enroll participants across 5 trials using a do-it-yourself (DIY) recruitment support framework described in the companion paper [12]. We then analyze cost-effectiveness of the recruitment strategies used.…”