Funders and olicymakers have become increasingly aware of the need to support studies that reflect the real world, comparative effectiveness of health interventions (CBO, 2007). Investigators striving to generate more practice-based evidence (Green, 2006) may be faced with unexpected and difficult challenges as they collaborate with community partners, seek to conduct high-impact, patient-centered research in clinical practice settings, and negotiate an increasingly integrated health information technology environment. However, the multiple barriers to research translation are potentially within the control of researchers and program developers (Glasgow and Emmons, 2007).Tracking critical trial metrics and milestones, and working closely with investigators to understand their progress, can direct attention to social, organizational, and ecological factors linked to more efficient and effective trial planning and implementation. The National Institutes of Health (NIH) initiative to support a group of 12 varied (across six NIH institutes) low-cost, pragmatic, patient-centered RCTs provides the opportunity to improve our current knowledge of what works when conducting these potentially high-impact trials and to systematically evaluate the impact of the required design elements on key metrics such as trial efficiency, cost, and impact. The NIH is seeking an evaluation and administration coordinating center to assess methods and processes that contribute to success during the UH2 planning phase (Year 1) and the UH3 implementation phase (Years 2 to 5). The UH2 planning phase will focus on how efficiently each grantee achieves start-up and planning milestones, assess time required for trial readiness, and evaluate strategies associated with success. During the UH3 implementation phase, the evaluation will consider the timeliness of recruitment, patient retention, success using integrated electronic sources, and the ability to answer key research questions. The evaluation and administrative coordinating center will (1) conduct a utilization-focused, mixed-methods program evaluation of the readiness and success of the trials funded under RFA-HL-14-019; and (2) support the NIH by providing administrative support for trials funded under RFA-HL-14-019, including assisting grantees with documentation of milestones, communication tasks, and meeting logistics.
With support by an evaluation and administration coordinating center, grantees will document the progress of trials that are conducted in 'real-world' settings with broad patient representation and patient- or provider- level trial endpoint, which provides an opportunity to identify the factors associated with high-functioning and high- impact trials. The UH2 planning phase will focus on how efficiently each grantee achieves quantifiable startup and planning milestones, assess time required for trial readiness, and evaluate strategies associated with success. During the UH3 implementation phase, the evaluation will consider the timeliness of recruitment, patient retention, success using electronic sources, and the ability to answer key research questions. (End of Abstract)
| Lipman, Paula Darby; Loudon, Kirsty; Dluzak, Leanora et al. (2017) Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains. Trials 18:532 |
