Browsing by Subject "Randomized controlled trials as topic"

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    EHR-based cohort assessment for multicenter RCTs: a fast and flexible model for identifying potential study sites
    (Oxford University Press, 2022) Nelson, Sarah J.; Drury, Bethany; Hood, Daniel; Harper, Jeremy; Bernard, Tiffany; Weng, Chunhua; Kennedy, Nan; LaSalle, Bernie; Gouripeddi, Ramkiran; Wilkins, Consuelo H.; Biomedical Engineering and Informatics, Luddy School of Informatics, Computing, and Engineering
    Objective: The Recruitment Innovation Center (RIC), partnering with the Trial Innovation Network and institutions in the National Institutes of Health-sponsored Clinical and Translational Science Awards (CTSA) Program, aimed to develop a service line to retrieve study population estimates from electronic health record (EHR) systems for use in selecting enrollment sites for multicenter clinical trials. Our goal was to create and field-test a low burden, low tech, and high-yield method. Materials and methods: In building this service line, the RIC strove to complement, rather than replace, CTSA hubs' existing cohort assessment tools. For each new EHR cohort request, we work with the investigator to develop a computable phenotype algorithm that targets the desired population. CTSA hubs run the phenotype query and return results using a standardized survey. We provide a comprehensive report to the investigator to assist in study site selection. Results: From 2017 to 2020, the RIC developed and socialized 36 phenotype-dependent cohort requests on behalf of investigators. The average response rate to these requests was 73%. Discussion: Achieving enrollment goals in a multicenter clinical trial requires that researchers identify study sites that will provide sufficient enrollment. The fast and flexible method the RIC has developed, with CTSA feedback, allows hubs to query their EHR using a generalizable, vetted phenotype algorithm to produce reliable counts of potentially eligible study participants. Conclusion: The RIC's EHR cohort assessment process for evaluating sites for multicenter trials has been shown to be efficient and helpful. The model may be replicated for use by other programs.
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    Ensuring Intervention Fidelity of an Attention Control Arm in a Multi-Site Randomized Controlled Trial
    (Wolters Kluwer, 2024) Newman, Amy R.; Moody, Karen M.; Becktell, Kerri; Connelly, Erin; Holladay, Cynthia; Parisio, Katie; Powell, Jonathan L.; Steineck, Angela; Hendricks-Ferguson, Verna L.; Pediatrics, School of Medicine
    Background: Intervention fidelity is a critical element of randomized controlled trials, yet reporting of intervention fidelity among attention control arms is limited. Lack of fidelity to attention control procedures can affect study outcomes by either overestimating or underestimating the efficacy of the intervention under examination. Objectives: This brief report describes the approach researchers took to promote fidelity to the attention control arm of a pediatric palliative care randomized controlled trial funded by the National Institutes of Health. Methods: The Informational Meetings for Planning and Coordinating Treatment trial aims to determine the efficacy of a communication intervention that uses care team dyads (i.e., physicians partnered with nurses or advanced practice providers) to engage parents of children with cancer who have a poor prognosis in structured conversations about prognostic information, goals of care, and care planning. The intervention is compared with an attention control arm, which provides parents with structured conversations on common pediatric cancer education topics, such as talking to their child about their cancer, clinical trials, cancer treatment, side effects, and so forth. National Institutes of Health guidelines for assessing and implementing strategies to promote intervention fidelity were used to design (a) the attention control arm of a randomized controlled trial, (b) related attention control arm training, and (c) quality assurance monitoring. Results: Attention control study procedures were designed to mirror that of the intervention arm (i.e., same number, frequency, and time spent in study visits). Cluster randomization was used to allocate care team dyads to one arm of the randomized controlled trial. Care team dyads assigned to the attention control arm participated in online training sessions to learn attention control procedures, the different roles of research team members, and quality assurance methods. Fidelity to attention control procedures is assessed by both the interveners themselves and a quality assurance team. Discussion: Study design, training, and delivery are all critical to attention control fidelity. Baseline training often needs to be supplemented with booster training when time gaps occur between study start-up and implementation. Quality assurance procedures are essential to determine whether interveners consistently deliver attention control procedures correctly.