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National dissemination of the accrual to clinical trials (ACT) network across the clinical and translational science award (CTSA) consortium: Leveraging big data to enable cohort discovery in multi-site trials

12/04/2018

Lindsay Lennox, Anne Schuster, Elaine Morrato

AcademyHealth

The Accrual to Clinical Trials (ACT) Network – a HIPAA-compliant tool for querying de-identified electronic health record data – includes 21 CTSA academic medical research centers (contributing 60+ million patient records), with 27 additional CTSAs onboarding. ACT dissemination-implementation is grounded in systems-thinking and Diffusion of Innovation Theory: (1) emphasizing relative advantages of using big data for cohort discovery/trial design and compatibility with existing ‘Jobs to be Done’ workflows; (2) involving both mass media (co-branded web resources) and interpersonal (local CTSA) communication channels; (3) acknowledging adoption as a time-based process and (4) leveraging CTSA social norms/incentives for translating clinical innovation. Core dissemination resources were provided nationally to jumpstart local CTSA adaptation and use. Time-to-adoption metrics for 19 CTSAs are presented. Dissemination-implementation planning followed technical implementation. Median time from e-mail dissemination invitation to “quick start” web-conference calls was 37 days (IQR=30–49), reflecting an internal process of identifying key CTSA stakeholders beyond the teams who established technical readiness. Median time was 46 days (IQR =17–53) to respond to a request for launch details to create a locally-adapted ACT website resource powered by the national platform (www.ACTNetwork.us/national). This timeframe reflects significant multi-disciplinary workflow integration not addressed during uni-disciplinary IT implementation. Overall, the median time from e-mail invitation to delivery of locally-customized ACT dissemination resources was 121 days (IQR=121–147) for the 11 CTSAs who have completed this step, reflecting both local and national dissemination activities and the natural academic calendar rhythm. National scale-up and system-based integration of new big data technology across health research organizations illustrates the phenomenon of “adoption as a time-based process”. Studying the steps involved for the ACT Network can inform future scale-up of innovation through the CTSA consortium. Performing technical readiness and dissemination planning activities in parallel (versus sequentially) is one means for accelerating implementation....

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Accrual to Clinical Trials (ACT): a clinical and translational science award consortium network

08/21/2018

Shyam Visweswaran et al.

JAMIA open

The Accrual to Clinical Trials (ACT) network is a federated network of sites from the National Clinical and Translational Science Award (CTSA) Consortium that has been created to significantly increase participant accrual to multi-site clinical trials. The ACT network represents an unprecedented collaboration among diverse CTSA sites. The network has created governance and regulatory frameworks and a common data model to harmonize electronic health record (EHR) data, and deployed a set of Informatics for Integrating Biology and the Bedside (i2b2) data repositories that are linked by the Shared Health Research Information Network (SHRINE) platform. It provides investigators the ability to query the network in real time and to obtain aggregate counts of patients who meet clinical trial inclusion and exclusion criteria from sites across the United States. The ACT network infrastructure provides a basis for cohort discovery and for developing new informatics tools to identify and recruit participants for multi-site clinical trials....

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