A welcome message and a new educational offering from the Implementation & Impact section of the curriculum wheel have been posted (1-1.5 hours of primary open access content).
This website will be updated every Monday (by 12:00 PM Eastern) or Tuesday (if Monday is a holiday). Given that the design, implementation, and management of pragmatic trials is a non-linear process, featured modules will relate to various sections of the curriculum wheel over time.
Welcome from the Executive Director (N2: Network of Networks): 2-min video.
Summary: Rebecca Barnes (Executive Director - N2: Network of Networks) welcomes learners to the program.
Implementation & Impact Section
Designing an intervention for testing in a pragmatic trial
NIH Pragmatic Trials Collaboratory - Designing With Implementation in Mind (February 28, 2020): 17-min webinar (15-slide presentation, slides 7-21)
Summary: Leah Tuzzio and Vincent Mor emphasize that health systems will be more likely to implement and sustain an intervention, post-trial, if the intervention was designed with the appropriate partnerships at the outset of the trial. Encourages researchers to consider how the intervention impacts workflows (e.g., Who will deliver the intervention? How difficult is it to implement?) and to think about the value proposition of the intervention for health system leaders. Pragmatic elements to intervention delivery are discussed (e.g., relying on existing clinical staff to implement interventions) along with the need to document variation in the delivery of the intervention during the trial. Two case studies are discussed (i.e., interventions in the “ABATE” and “PROVEN” pragmatic trials).
NIH Pragmatic Trials Collaboratory - Designing With Implementation and Dissemination in Mind (December 27, 2021): 4-page document.
Summary: Emphasizes that researchers should consider the (potential) post-trial implementation of an intervention when initially designing their pragmatic trial (i.e., thoroughly examining the sustainability of an effective intervention once the trial is completed). Concludes with key considerations for designing an intervention for post-trial sustainability and implementation: e.g., What impact do you want to have after the trial’s findings are published and disseminated to decisionmakers? What are the needs of the audiences (e.g., patients, clinicians, health system leaders) who may use the research to make decisions? Who should be engaged as partners from the beginning to help design the intervention to be tested in the trial? Is the intervention designed in a way so that it can be delivered in a variety of care settings (both during and after the trial)? Who can deliver the intervention in usual care settings? Are specific resources needed to deliver the intervention?
Baier RR, et al. Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial. BMC Med Res Methodol. 2019 Jul 18;19(1):156. (8-page paper)
Summary: A tool for researchers to assess an intervention’s readiness for evaluation in a pragmatic trial. RAPT includes nine domains: implementation protocol, evidence, risk, feasibility, measurement, cost, acceptability, alignment, and impact. The domains reflect a range of considerations regarding the feasibility of successfully delivering an intervention pragmatically (during a trial) and the potential of implementing and sustaining an (effective) intervention, in real-world settings, after the trial is completed.
Hikaka J, et al. Modifications of the readiness assessment for pragmatic trials tool for appropriate use with Indigenous populations. BMC Med Res Methodol. 2024 May 31;24(1):121. (18-page paper)
Summary: Identifies adaptions necessary for the application of the RAPT (readiness assessment for pragmatic trials) tool in pragmatic trials that involve Indigenous Peoples and communities. After questionnaires and interviews with researchers in New Zealand and the United States, five new domains were proposed to support pro-equity research in Indigenous communities: Indigenous Data Sovereignty; Acceptability – Indigenous Communities; Risk of Research; Research Team Experience; Established Partnership. RAPT-Indigenous (RAPT-I) can be used to increase the robustness and cultural appropriateness of the intervention being evaluated in a pragmatic trial. *Please note that this modification of the RAPT tool may omit important considerations relevant to Indigenous Peoples in Canada.