Background
Trauma, trauma
Over the past decade, both pragmatic and implementation science clinical trial research methods have advanced substantially [Pragmatic and implementation randomized clinical trials have natural areas of overlap. For example, multisite pragmatic and implementation trials grapple with similar regulatory issues [Prior investigations straddling pragmatic and implementation clinical trial approaches have focused on the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS), a tool for rating clinical trials on the pragmatic-explanatory spectrum [More recently, the PRECIS-2-Provider Strategies (PS) tool has been developed with the aim of better characterizing trials where participants are health care providers [Over the past decade, members of the investigative team have developed and rolled out two multi-site cluster randomized clinical trials in US trauma care systems, the Disseminating Organizational Screening and Brief Intervention Services (DO-SBIS) and the Trauma Survivors Outcomes and Support (TSOS) investigations [The current investigation builds upon and extends these prior investigations by working to further the methodologic integration of pragmatic and implementation science clinical trial approaches while simultaneously incorporating policy research perspectives. The investigation used the PRECIS-2 and PRECIS-2-PS tools to rate patient and provider-level characteristics of the DO-SBIS and TSOS trials. The investigation examined whether both tools could be simultaneously used to feasibly and reliably rate the two trials. The study employed the Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) qualitative approach to systematically document observations regarding the feasibility of using the PRECIS-2 and PRECIS-2-PS to rate the trials. RAPICE was also used to make clinical trial-related policy observations. The RAPICE observations sought to identify PRECIS-2 and PRECIS-2-PS domains that overlapped with or were potentially impacted by College policy. Given that the original intent of the PRECIS tools did not include a policy focus, RAPICE also aimed to augment the PRECIS coding with policy relevant observations.