Gathering and learning from relevant clinical data: a new framework

Abstract

Given the rising costs of health care in today's economic environment, the need for effective, value-driven care has never been more pressing. While the U.S. health care system strives continually to improve patient outcomes, it struggles with the inadequacies due to variation in care and the inefficiencies of unnecessary resource utilization. The tools traditionally used to study care, from retrospective studies to randomized controlled trials, may be inadequate to address the complicated, interdependent questions related to defining effective care. To overcome the deficiencies of these traditional tools and better optimize our health care system, a new kind of methodology is required--one that integrates the functionality of previously existing tools in a novel way. Standardized Clinical Assessment and Management Plans (SCAMPs) were designed to accomplish this goal. A SCAMP is a care pathway, designed by clinicians, to guide medical decision making around a particular disorder. SCAMPs are unique in that they invite knowledge-based diversions from their recommendations and are accompanied by data collection and continuous improvement processes. Through these mechanisms, SCAMPs successfully reduce practice variation, optimize resource use, and create an integrated medical learning system which overcomes many of the inadequacies of traditional research tools. As such, the SCAMP paradigm may represent an important breakthrough in the effort to define and implement effective health care.

Figure 1

The theory-building process. Descriptive theory building involves characterizing the relationship between a phenomenon and attributes associated with that phenomenon. A “cognitive leap” from this established relationship can then be made to formulate a theory on a causality between attributes and outcomes, which can be tested and refined through the process of prescriptive theory building. Anomalies (outliers, diversions, or unexpected outcomes) detected throughout this process can be used to revise the underlying theory. Ultimately, a proven theory can be used to create an explanatory model for the phenomenon. Adapted from Christensen CM, Carlile PR. Course research: Using the case method to build and teach management theory. Acad Manage Learn Educ. 2009;8:240–251.

Figure 2

Mapping of traditional clinical knowledge-building tools. Case reports, cross-sectional surveys, cohort studies, and case–control studies are all descriptive in their theory building; they cannot prove causality. Clinical trials (including randomized controlled trials) are the primary method of prescriptive theory building and proving causality in medicine. Knowledge generated from the above studies can be synthesized to build understanding of disease management and formulate “best practice” recommendations.

Figure 3

Fitting the Standardized Clinical Assessment and Management Plan (SCAMP) process into the theory-building framework. The process of designing and implementing a SCAMP is intended to span across both descriptive and prescriptive theory building.