Process mapping with failure mode and effects analysis to identify determinants of implementation in healthcare settings: a guide.

Background: Generating and analyzing process maps can help identify and prioritize barriers to the implementation of evidence-based practices in healthcare settings. Guidance on how to systematically apply and report these methods in implementation research is scant. We describe a method combining a qualitative approach to developing process maps with a quantitative evaluation of maps drawn from the quality improvement literature called failure mode and effects analysis (FMEA).

Methods: We provide an outline and guidance for how investigators can use process mapping with FMEA to identify and prioritize barriers when implementing evidence-based clinical interventions. Suggestions for methods and reporting were generated based on established procedures for process mapping with FMEA and through review of original research papers which apply both methods in healthcare settings. We provide case examples to illustrate how this approach can be operationalized in implementation research.

Results: The methodology of process mapping with FMEA can be divided into four broad phases: 1) formulating a plan, 2) generating process maps to identify and organize barriers over time, 3) prioritizing barriers through FMEA, and 4) devising an implementation strategy to address priority barriers. We identified 14 steps across the four phases. Two illustrative examples are provided. Case 1 describes the implementation of referrals to chiropractic care for adults with low back pain in primary care clinics. Case 2 describes the implementation of a family navigation intervention for children with autism spectrum disorder seeking care in pediatric clinics. For provisional guidance for reporting, we propose the REporting Process mapping and Analysis for Implementation Research (REPAIR) checklist.

Conclusions: Process mapping with FMEA can elucidate barriers and facilitators to successful implementation of evidence-based clinical interventions. This paper provides initial guidance for more systematic applications of this methodology in implementation research. Future research should use a consensus-building approach, such as a multidisciplinary Delphi panel, to further delineate the reporting standards for studies that use process mapping with FMEA.