Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial

Abstract

Abstract Background Pragmatic randomized, controlled trials (PCTs) test the effectiveness of interventions implemented in routine clinical practice. Because PCT findings are generalizable, this approach is gaining momentum among interventionists and funding agencies seeking to accelerate the testing and adoption of evidence-based strategies to improve care and outcomes. Particular attention is being paid to non-pharmacological interventions, which are often complex and may be difficult to uniformly implement across multiple sites. While many such non-pharmacological interventions have proven efficacious in small trials, most have not been widely adopted. PCTs could accelerate effectiveness testing and adoption, yet there are no established criteria to identify interventions ready for testing in a PCT. Methods We convened 30 interventionists and healthcare leaders to identify criteria to assess the readiness of non-pharmacological interventions for PCTs. Based on this discussion, we created a model with multiple domains, qualitative scoring guidelines for each domain, and a graphical summary of readiness assessments. All workshop participants had an opportunity to review and comment on the resulting model; three piloted it with their own interventions. Several other experts also provided input. Results The Readiness Assessment for Pragmatic Trials (RAPT) model enables interventionists to assess an intervention’s readiness for PCTs. RAPT includes nine domains: implementation protocol, evidence, risk, feasibility, measurement, cost, acceptability, alignment, and impact. Domains reflect a range of considerations regarding the feasibility of successfully employing PCT methods and the prospect of an intervention’s widespread adoption, if proven effective. Individuals evaluating an intervention are asked to qualitatively assess each domain from low to high readiness. In this report, we provide assessment guidelines and examples of scored interventions. Conclusions RAPT is the first model to help interventionists and funders assess the extent to which interventions are ready for PCTs. Scoring efficacious interventions using RAPT can inform research team discussions regarding whether or not to advance an intervention to effectiveness testing using a PCT and how to design that PCT.

Keywords

• Pragmatic clinical trial
• Pragmatic trial
• Effectiveness
• Translational research
• Implementation science
• Model