The RIC COVID-19 Recruitment &amp; Retention Toolkit: A community-informed resource of recruitment tools and strategies for clinical trial investigators

Kennedy, Nan; Dunagan, Julia; Boone, Leslie R.; Israel, Tiffany; Mayers, Stephanie A.; Dunkel, Leah; Cook, S. K.; Pimentel, Pamela; Edwards, Terri; Stroud, Mary; Wilkins, Consuelo H.; Harris, Paul A.

doi:10.1017/cts.2022.429

Cited by 3 publications

(3 citation statements)

References 17 publications

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“…The new RIC Recruitment & Retention Materials Content + Design Toolkit serves as a community-informed resource for research teams to use to develop their own study recruitment and retention materials. Toolkit concepts and material assets were informed by key community stakeholders, a guiding principle of the RIC’s work [ 12 ], and integrated expertise and best practices in content development, health literacy [ 19 ], and graphic design. The templates provided offer research teams easy access to professionally designed, customizable recruitment and retention materials on a no-cost, user-friendly platform.…”

Section: Discussionmentioning

confidence: 99%

“…The Recruitment Materials resource line offers support for a variety of clinician- and participant-facing tools, including review and consultation on print materials, websites, and social media, as well as custom design, logos, templates, and development of mobile study applications. More recently, the RIC has developed and disseminated several publicly available community-informed tools for investigators and study teams to use when developing recruitment strategies for trials [ 12 ]. This paper describes the creation and contents of a new RIC Recruitment & Retention Materials Content + Design Toolkit , which offers research teams guidance, actionable tips, resources, and customizable templates for creating trial-specific study materials.…”

Section: The Recruitment Innovation Centermentioning

confidence: 99%

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The RIC Recruitment & Retention Materials Toolkit – a resource for developing community-informed study materials

Mayers,

Cook,

Rantala

et al. 2023

J. Clin. Trans. Sci.

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Clinical trials face many challenges with meeting projected enrollment and retention goals. A study's recruitment materials and messaging convey necessary key information and therefore serve as a critical first impression with potential participants. Yet study teams often lack the resources and skills needed to develop engaging, culturally tailored, and professional-looking recruitment materials. To address this gap, the Recruitment Innovation Center recently developed a Recruitment & Retention Materials Content and Design Toolkit, which offers research teams guidance, actionable tips, resources, and customizable templates for creating trial-specific study materials. This paper seeks to describe the creation and contents of this new toolkit.

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Section: Discussionmentioning

confidence: 99%

Section: The Recruitment Innovation Centermentioning

confidence: 99%

The RIC Recruitment & Retention Materials Toolkit – a resource for developing community-informed study materials

Mayers,

Cook,

Rantala

et al. 2023

J. Clin. Trans. Sci.

Self Cite

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“…Other activities addressing the COVID-19 pandemic include a coordinated response to the Federal Register Request for Information: Clinical Research Infrastructure and Emergency Clinical Trials where the TIN provided advice regarding critical randomized trial resources needed for a national emergency response program. Additionally, an RIC COVID-19 Recruitment and Retention Toolkit was developed to provide investigators with strategies and resources on recruitment and retention planning for COVID-19 research …”

Section: Tin Areas Of Impactmentioning

confidence: 99%

Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials

Harris,

Dunsmore,

Atkinson

et al. 2023

JAMA Netw Open

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ImportanceMulticenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC). This unique partnership has aimed to address critical roadblocks that impede the design and conduct of mRCTs, in expectation of accelerating the translation of novel interventions to clinical practice. The TIN’s challenges and achievements are described in this article, along with examples of innovative resources and processes that may serve as useful models for other clinical trial networks providing operational and recruitment support.ObservationsThe TIN has successfully integrated more than 60 CTSA institution program hubs into a functional network for mRCT implementation and optimization. A unique support system for investigators has been created that includes the development and deployment of novel tools, operational and recruitment services, consultation models, and rapid communication pathways designed to reduce delays in trial start-up, enhance recruitment, improve engagement of diverse research participants and communities, and streamline processes that improve the quality, efficiency, and conduct of mRCTs. These resources and processes span the clinical trial spectrum and enable the TICs and RIC to serve as coordinating centers, data centers, and recruitment specialists to assist trials across the National Institutes of Health and other agencies. The TIN’s impact has been demonstrated through its response to both historical operational challenges and emerging public health emergencies, including the national opioid public health crisis and the COVID-19 pandemic.Conclusions and RelevanceThe TIN has worked to reduce barriers to implementing mRCTs and to improve mRCT processes and operations by providing needed clinical trial infrastructure and resources to CTSA investigators. These resources have been instrumental in more quickly and efficiently translating research discoveries into beneficial patient treatments.

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Probiotic Therapy of Gastrointestinal Symptoms During COVID-19 Infection: A Randomized, Double-Blind, Placebo-Controlled, Remote Study

Horvath,

Haller,

Feldbacher

et al. 2024

Nutrients

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Background: The novel coronavirus (SARS-CoV-2) led to gastrointestinal manifestations in up to 50% of cases, with diarrhea being common, and probiotics have been suggested as a potential treatment. Aim: This study aimed to assess changes in the microbiome and the effects of a multispecies probiotic in patients with COVID-19 in home quarantine through a fully remote telemedical approach. Methods: Thirty patients were randomized to receive either the Ecologic AAD probiotic (Winclove Probiotics, Amsterdam, The Netherlands), on the market as OMNi-BiOTiC 10 (Allergosan, Austria), or a placebo for 30 days in a 2:1 ratio. Respiratory and gastrointestinal symptoms were monitored in 2–10-day intervals via online surveys, and five stool samples were collected during the 30-day study period for microbiome and metabolomics analyses. Twenty-four healthy volunteers served as controls. Results: Of the 30 patients, 26 completed this study (10 placebo, 16 probiotic). Patients reported respiratory symptoms and a diminished gastrointestinal quality of life, both of which improved significantly during the study period, irrespective of the intervention. Compared to controls, infected patients showed significant alterations in the fecal microbiome (p = 0.002), including an increase in Bacteroidetes and decreases in Christensenellaceae, Ruminococcaceae, and Gammaproteobacteria, along with metabolomic changes. Probiotic treatment significantly modulated the patients’ microbiome beta diversity (p = 0.001) and introduced the Enterococcus faecium W54 strain. Symptoms, COVID-19-related taxa, and the fecal metabolome were not affected by the intervention. Conclusions: Patients with mild COVID-19 disease in home quarantine exhibited respiratory symptoms, a reduced gastrointestinal quality of life, and changes in the fecal microbiome and metabolome.

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The RIC COVID-19 Recruitment & Retention Toolkit: A community-informed resource of recruitment tools and strategies for clinical trial investigators

Abstract: This version may be subject to change during the production process.

Cited by 3 publications

References 17 publications

The RIC Recruitment & Retention Materials Toolkit – a resource for developing community-informed study materials

The RIC Recruitment & Retention Materials Toolkit – a resource for developing community-informed study materials

Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials

Probiotic Therapy of Gastrointestinal Symptoms During COVID-19 Infection: A Randomized, Double-Blind, Placebo-Controlled, Remote Study

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