Concept and implementation of a study dashboard module for a continuous monitoring of trial recruitment and documentation

Toddenroth, Dennis; Sivagnanasundaram, Janakan; Prokosch, Hans‐Ulrich; Ganslandt, Thomas

doi:10.1016/j.jbi.2016.10.010

Cited by 13 publications

(11 citation statements)

References 57 publications

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“…This multisite randomized controlled trial (RCT) implemented a comprehensive intervention arm that combines 2 previously tested approaches—Centers of Disease Control (CDC) Retention in Care (RIC) [4] and Participating and Communicating Together (PACT) [5] to support the establishment of early behaviors that help patients to arrive at scheduled medical appointments and learn to take ART medications as prescribed.…”

Section: Methodsmentioning

confidence: 99%

“…However, recruitment activities for multisite trials are challenging [3]. Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and reduction of errors [4,5]. Central study coordinators are typically tasked with tracking and documenting participant activities [3,4].…”

Section: Introductionmentioning

confidence: 99%

“…Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and reduction of errors [4,5]. Central study coordinators are typically tasked with tracking and documenting participant activities [3,4]. Electronic data capture is a necessity for multisite randomized clinical trials and is replacing the practice of manual data entry on paper forms [4].…”

Section: Introductionmentioning

confidence: 99%

“…Central study coordinators are typically tasked with tracking and documenting participant activities [3,4]. Electronic data capture is a necessity for multisite randomized clinical trials and is replacing the practice of manual data entry on paper forms [4]. There are several electronic data capture systems available for the conduct of randomized clinical trials, and while there are some examples of behavioral sciences research being supported by software [2], this practice is much less common than in the clinical trials space.…”

Section: Introductionmentioning

confidence: 99%

“…Like most randomized clinical trials, in behavioral intervention trials, participants typically complete several study procedures at different time points. Prior studies indicate that a single coordinator may simultaneously work on more than one study and customized study software solutions that allow accurate tracking and documentation of encounters are needed [4]. With limited literature available on multisite behavioral intervention trials supported by custom software, there is little opportunity for such investigators to learn how this technology could facilitate the accomplishment of their research goals.…”

Section: Introductionmentioning

confidence: 99%

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A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey

et al. 2017

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BackgroundMeticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform.ObjectiveThis manuscript aimed to: (1) describe the design and implementation of a Web-based software application to facilitate deployment of a multisite behavioral science intervention; and (2) report on results of a survey to capture end-user perspectives of the impact of this platform on the conduct of a behavioral intervention trial.MethodsIn order to support the implementation of the NIAID-funded trial iENGAGE, we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS. We integrated the study coordinator into the informatics team to participate in the software development process. Here, we report the key software features and the results of the 25-item survey to evaluate user perspectives on research and intervention activities specific to the iENGAGE trial (N=13).ResultsThe key features addressed are study enrollment, participant randomization, real-time data collection, facilitation of longitudinal workflow, reporting, and reusability. We found 100% user agreement (13/13) that participation in the database design and/or testing phase made it easier to understand user roles and responsibilities and recommended participation of research teams in developing databases for future studies. Users acknowledged ease of use, color flags, longitudinal work flow, and data storage in one location as the most useful features of the software platform and issues related to saving participant forms, security restrictions, and worklist layout as least useful features.ConclusionsThe successful development of the iENGAGE behavioral science research platform validated an approach of early and continuous involvement of the study team in design development. In addition, we recommend post-hoc collection of data from users as this led to important insights on how to enhance future software and inform standard clinical practices.Trial RegistrationClinicaltrials.gov NCT01900236; (https://clinicaltrials.gov/ct2/show/NCT01900236 (Archived by WebCite at http://www.webcitation.org/6qAa8ld7v)

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Section: Methodsmentioning

confidence: 99%