ABSTRACT
The diagnostic process unfolds across multiple settings over time. Risk factors for error in each setting may
vary, but for the patient, once a serious diagnostic error occurs, the specific clinical area where it happened is
unimportant. Outpatient and inpatient settings have similar rates of diagnostic harm. Interactions within and
between clinical teams and settings may either create resilience or increase risks for failure. Resilience
engineering, or Safety II, is based on the concept that safety is a consequence of adaptations to the changing
conditions of a system’s function. Robust communication supports a shared mental model that may create
diagnostic resilience. Currently, clinician-patient/family communication along the diagnostic journey is
haphazard. For example, pediatricians consistently fail to tell parents about “red flags” which are signs of a
serious complication requiring immediate attention. Among children with chronic conditions at home, we found
that 14% had serious diagnostic delays caused by parental misunderstanding of instructions. Pediatric
diagnostic safety is understudied, and overall rates and types of outpatient pediatric diagnostic errors is
unknown. To support robust communication with families of hospitalized children, we developed a structured
communication intervention (PFC I-PASS) which reduces medical errors by 38%. I-PASS has been pilot tested
for use during hospital discharge with similar success. Secondary analyses suggests that I-PASS may be
effective at reducing diagnostic errors. PFC I-PASS has not been used in the outpatient setting and its impact
on diagnostic safety has not been tested. Among children with multiple chronic conditions, we aim to: 1.
Characterize the diagnostic journey, focusing on successes, errors, and patient/family and clinician
communication; 2. Adapt PFC I-PASS to create Outpatient PFC I-PASS, a structured communication
intervention for patients/families and clinicians in the outpatient setting; 3. Evaluate the effectiveness of PFC I-
PASS (outpatient and discharge) to improve patients/family and clinician communication and experience, and
to reduce errors and harm. The proposed Diagnostic Center of Excellence is comprised of two cores: a
Methods Core and an Education and Dissemination Core. Cores include expertise in the diagnostic safety,
Safety I and II, communication, medical education, and health disparities. The cores will work with Patient and
Parent, Clinician, and Health System Leader Advisory Panels. At Boston Children’s Hospital, Cincinnati
Children’s Hospital Medical Center and Children’s Hospital of Philadelphia, to address aims, we will employ
observations, interviews, simulation, surveys, chart review, using S1 and S2 approaches. We will evaluate the
impact of adapted PFC-IPASS on diagnostic errors using interrupted time series analysis. Methods will be
immediately available to other Centers of Diagnostic Excellence and, through several networks, to over 200
health systems. Combining S1 and S2 approaches to characterize the diagnostic journey and test interventions
has the potential to transform patient safety science.