Methods for Rescuing Implementation Trials that Have Gone Off the Rails
Geoffrey Curran, PhD
University of Arkansas for Medical Sciences
JD Smith, PhD
University of Utah
Alison Hamilton, PhD
UCLA
ABSTRACT:
Implementation trials frequently run into unanticipated challenges which, if not successfully addressed, can threaten their integrity and derail implementation quality and speed. These problems, and potential solutions, remain largely tacit. In this panel, 4 principal investigators describe how their extramurally-funded implementation trials encountered potentially study-ending problems: Shifting context barriers (e.g., staffing, local policy, partner priorities) resulting in problems with site recruitment, retention, and/or engagement; missing data; mis-specified implementation strategies; and failed strategies (to name some). Methods to address these problems included rapid formative evaluation, external advisory assistance, partnered study component/protocol revision, and early funder communication.