Pulmonary Embolism Clinical Trial
DESIGN: An IRB-approved, HIPAA-compliant prospective randomized controlled trial conducted
from January 1, 2012-December 31, 2013.
SETTING: The ED of an urban Level-I adult trauma center with existing CDS for CTPE.
PARTICIPANTS: All attending physicians were stratified into quartiles by 2012 CTPE use and
randomized to receive feedback reporting or not.
INTERVENTION: Quarterly performance feedback reports consisting of individual and anonymized
group data on EBG adherence (using the Wells criteria), CTPE use (CTPEs per 1,000 patients),
and yield (percentage of CTPEs positive for PE) beginning January 2013.
Setting and Subjects This IRB-approved and HIPAA-compliant prospective randomized controlled
trial was conducted from January 1, 2012 to December 31, 2013 in the ED of an urban Level-I
adult trauma center. Imaging CDS was deployed for all CTPE requests throughout the study
period as previously reported. Ordering providers could ignore the evidence presented in CDS
and proceed with CTPE requests deviating from evidence-based guidelines without
interference. The investigators included all attending emergency physicians and, prior to
randomization, stratified them into quartiles by 2012 CTPE use. Physicians were randomized
by quartile into two groups using a random number generator: the intervention group received
individualized feedback reports on CTPE adherence to EBG, use (defined as number of CTPEs
per 1,000 patients), and yield (percentage of CTPEs positive for PE), and the control group
did not.
Data Collection Use of CTPEs for each physician was calculated using the number of completed
CTPE examinations and the total number of patients seen during the quarter. Yield of CTPEs
for acute PE was determined using a previously validated natural language processing tool
and reported as a percentage of total CTPEs completed. Adherence to EBG was determined by
applying the Wells Criteria and reviewing the serum D-dimer levels (if obtained). The
discrete criteria making up the Wells Criteria were prospectively documented in the
investigators computerized order entry (CPOE) system at the time of order entry, as
previously reported.
In order to determine whether any differences observed in guideline adherence were the
result of "gaming" (erroneous data entry to either avoid potentially onerous CDS
interactions or to enhancing the physician's apparent performance on feedback reports) the
investigators performed manual chart reviews of 100 randomly chosen charts from each of the
two groups. These chart reviews were performed by an attending physician to assess
concordance between adherence to EBG calculated from the CDS data, and adherence to EBG
calculated from data documented in the ED visit clinical note. The sample size was
determined using a baseline concordance of 90% as previously reported, and chosen to detect
a difference in concordance of 15% between groups with a power of 80% and an alpha error
rate of 5%. Demographic data (including gender and both age and years since residency
training as measured at the beginning of the study period) was also captured for all the
attending physicians in the study.
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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