From controlled trial to community adoption: the multisite translational community trial

Abstract

Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers.

FIGURE 1

Schematic model of the multisite translational community trial. Note. The community serves as the beginning and endpoint of a feedback loop targeted to the individual who will receive the health message, or intervention. The message is delivered through portals and delivered by facilitators in a culturally relevant way. The behavior changes feed back to the community, resulting in improved health measures at the community level.

FIGURE 2

Multisite translational community trial construct and the Prevention Research Center network. Note. n = up to any number of sites; PRC = Prevention Research Center Program of the Centers for Disease Control and Prevention (CDC). The circles with dashed lines represent discrete diabetes–obesity prevention and control interventions at a specific primary site PRC. The circles with dotted lines represent comparable interventions at the primary site as well other sites, all tailored to local communities. The large black circle denotes the collective, global effort of a group of PRCs to establish a shared methodology for translating Diabetes Prevention Program components into sustainable community programming and to engage in rigorous, shared evaluation.