An Equity Focused Intervention to Improve Utilization of Guideline Concordant Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery
Phase: NA
Conditions: Venous Thromboembolism, Pulmonary Embolism, Deep Vein Thrombosis, Cancer, Surgery
Sponsor: Medical University of South Carolina

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Medical University of South Carolina 
Protocol 
 
 
An Equity Focused Intervention to Improve Utilization in Guideline Concordant Extended Venous 
Thromboembolism Prophylaxis After Major Cancer Surgery 
 
Principal Investigator: Thomas Curran, MD MPH 
 
Mentors/Co-investigators: Marvella Ford, PhD, Patrick Mauldin, PhD, Leslie Lenert, MD, MS, Shannon 
Phillips, PhD RN, Ashish Deshmukh, PhD MPH 
 
Grant Support: NCI P30CA138313-15S1 
Date: July 15, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Project Summary/Abstract  
 
Venous thromboembolism (VTE) following major cancer surgery is a significant contributor to morbidity and 
mortality. Extended VTE prophylaxis (ePpx) following major cancer surgery decreases the risk of post-hospital 
VTE and is recommended by professional societies. However, utilization of ePpx remains limited. Moreover, 
racial disparities exist for cancer associated outcomes including VTE and mortality. These inequities in broader 
cancer care suggest that disparities may exist related to the utilization of ePpx. This aspect of cancer care has 
not been studied through a lens of cancer health disparities. The reasons for low utilization of ePpx remain a 
significant knowledge gap. Electronic medical record (EMR)-based clinical decision support systems (CDSS) 
have been effective in improving adherence to inpatient VTE prophylaxis though has not been studied for ePpx. 
The overall objective of this work is to identify barriers and facilitators related to ePpx guideline adherence and 
convene stakeholders to develop and implement a multi-faceted educational intervention including an EMR-
based CDSS for increasing guideline adherence in a diverse oncology population. Our central hypothesis is that 
modifiable patient and surgeon factors exist, which provide an explanatory mechanism for poor adherence to 
ePpx guidelines (both by the surgeon and patient) and that these factors may be overcome by the equity focused 
intervention described below. We will test our hypotheses through these specific aims: 
Specific Aim 1: Characterize barriers and facilitators to ePpx guideline adherence as perceived by stakeholders 
via key informant interviews with a diverse group of patients and surgeons at four hospitals within the MUSC 
Health system that routinely perform abdominopelvic cancer surgery. 
Hypothesis 1: Barriers and facilitators related to ePpx use exist that are not forthcoming from clinical data; 
once uncovered, these factors will inform the educational interventions in Aims 2.1 and 2.2. 
Specific Aim 2.1: Conduct a stepped-wedge randomized trial including multi-faceted surgeon-focused 
education and academic detailing to evaluate the impact of an EMR-based CDSS to increase adherence to ePpx 
guidelines at the three selected hospitals.  
Hypothesis 2.1: The intervention will increase ePpx following abdominopelvic cancer surgery. 
Specific Aim 2.2: Evaluate the impact of VTE related pre-discharge education on patient adherence to ePpx 
via a pre-post study of patients undergoing abdominopelvic cancer surgery at the three selected hospitals.  
 
Hypothesis 2.2: Focused VTE related education will improve patient adherence.  
 
The application of rigorous qualitative research methodology to this clinical context will elucidate mechanisms to 
improve administration of guideline concordant ePpx. Pairing these data with a multi-faceted, stakeholder 
informed educational intervention, this work has the potential to significantly impact cancer care and mitigate 
cancer health disparities. 
 
The above study is funded by the National Cancer Institute through the Early-Stage Surgeon Scientist 
Program.  The protocol below pertains to Aim 2.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
 
A. Specific aims-------------------------------------------------------------------------------------------------------------------Page 4 
B. Background and significance--------------------------------------------------------------------------------------------Page 5-6 
C. Preliminary studies------------------------------------------------------------------------------------------------------------Page 6 
D. Research design, methods and analysis----------------------------------------------------------------------------Page 7-11 
E. Data Management-----------------------------------------------------------------------------------------------------------Page 12 
F. Protection of human subjects-----------------------------------------------------------------------------------------Page 12-15 
a. Characteristics of participants 
b. Potential risks 
c. Adequacy of protection against risks 
d. Potential benefits of the proposed research to the subjects and others 
G. References--------------------------------------------------------------------------------------------------------------------Page 15 
H. Appendix 1: Procedure/Diagnosis Codes-------------------------------------------------------------------------Page 21-25 
I. 
Appendix 2: Redcap Survey----------------------------------------------------------------------------------------------Page 26 
J. Appendix 3: IRB Approval---------------------------------------------------------------------------------------------Page 27-28 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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A. SPECIFIC AIMS 
This protocol will only discuss Aim 2 as the focus of this IRB submission.   
Specific Aim 2.1: Conduct a stepped-wedge randomized trial including multi-faceted surgeon-focused 
education and academic detailing to evaluate the impact of an EMR-based CDSS to increase adherence to ePpx 
guidelines at the three selected hospitals.  
Hypothesis 2.1: The intervention will increase ePpx following abdominopelvic cancer surgery. 
Specific Aim 2.2: Evaluate the impact of VTE related pre-discharge education on patient adherence to ePpx 
via a pre-post study of patients undergoing abdominopelvic cancer surgery at the three selected hospitals.  
 
Hypothesis 2.2: Focused VTE related education will improve patient adherence.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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B. BACKGROUND & SIGNIFICANCE 
 
B.1. Venous thromboembolism (VTE) is highly morbid and costly in cancer patients. Among 
abdominopelvic (gastrointestinal (GI), gynecologic (GYN), and urologic (GU)) cancer patients, those with VTE, 
including pulmonary embolism (PE) and deep vein thrombosis (DVT), had a 1.5 to 11.2 times increased risk of 
death within one year after controlling for age, cancer stage, and race.(22) VTE is also a leading cause of death 
after cancer surgery accounting for 46 percent of deaths within 30-days in a large prospective study of surgical 
oncology patients.(23) In addition to the nearly one-third of PE patients who present with sudden death,(24) a 
national study of surgical oncology patients showed a nearly ten percent mortality among those readmitted with 
postoperative VTE.(25) These entities come at a substantial financial cost. VTE nearly doubles the cost of care 
over five years in patients with cancer or those having surgery.(26, 27)        
 
B.2. In hospital and post-discharge VTE are common among surgical cancer patients. Cancer related 
hypercoagulability increases VTE risk 4-fold.(28) Compared to surgery for benign indications, abdominopelvic 
surgery for cancer has a 2- to 3-fold increased risk of VTE.(29) The Caprini model for 30-day postoperative VTE 
risk considers a score of 5 or greater to be “high risk.” Based on this model, any patient age 41-60 undergoing 
abdominopelvic surgery for cancer is “high risk” with a minimum estimated 30-day VTE risk of 1.33%.(30)  
Across commonly performed major cancer surgical resections, the median length of hospital stay ranges from 4 
to 10 days in national observational series.(31) It is thus unsurprising that post-hospital VTE accounts for 18% 
to 47% of VTE following abdominopelvic cancer surgery.(31-34)  
 
B.3. Extended VTE prophylaxis effectiveness and guidelines. Post-hospital extended VTE prophylaxis 
(ePpx) after major cancer surgery is safe and effective with a 2009 Cochrane review of randomized trials showing 
a reduction from 14% to 6% in any VTE and 1.7% to 0.2% in symptomatic VTE.(35) Since 2012, the American 
Academy of Chest Physicians,(36) the National Comprehensive Cancer Network,(37) the American Society of 
Clinical Oncology,(38) the European Association of Urology,(39) American College of Obstetricians and 
Gynecologists,(40) and the American Society of Colon and Rectal Surgery(41) have recommended 
consideration of ePpx after abdominopelvic cancer surgery using low molecular weight heparin (LMWH). A 2019 
Cochrane review evaluating an additional three randomized trials reaffirmed the safety and efficacy of ePpx.(42)  
 
B.4. Extended VTE prophylaxis utilization remains low. Yet, uptake of these recommendations has been 
limited. Across multiple sources including statewide surgical quality collaboratives, national administrative data 
and surgeon survey, ePpx ranged from thirteen to forty percent.(43-47) The reasons for low utilization have not 
been forthcoming from existing data and remain a significant knowledge gap; one we intend to bridge with the 
proposed study. Concerns for adverse bleeding events, cost, perceived limited evidence, surgeon awareness of 
guidelines, and patient adherence have been put forward as reasons for poor surgeon guideline adherence.(48)  
 
B.5. Racial disparities in cancer outcomes and cancer associated VTE. Decreased survival has been 
observed for Black patients across abdominopelvic cancers.(49-51) This phenomenon is likely multifactorial with 
environmental, societal, and genetic contributing factors. In conceptual support of this, racial residential 
segregation is associated with increased stage at presentation and decreased cancer specific survival for Black 
patients with colorectal cancer.(52) In the Southern US in particular, rural populations have shown higher stage 
at presentation for cancers with preventive opportunities.(53) Black patients with abdominopelvic malignancy are 
40 to 60 percent more likely to suffer VTE overall,(54) and 56 percent more likely  to suffer VTE after cancer 
surgery than White patients.(55) These inequities in broader cancer care suggest that disparities may exist 
related to the utilization of ePpx. Indeed, this aspect of cancer care has not been studied through a lens of cancer 

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health disparities. Inequities related to socioeconomic status and geography (i.e., rural area of residence) may 
be considered in addition to race related disparities to examine the intersection of these characteristics.    
 
B.6. Electronic medical record (EMR) based interventions to improve inpatient VTE prophylaxis. 
Computerized clinical decision support systems (CDSS) have been deployed in a variety of clinical contexts  to 
improve healthcare quality.(56) A Cochrane review of 13 randomized controlled trials (RCTs) evaluating human 
or EMR-based alerts to improve inpatient VTE prophylaxis showed a 21% increase in VTE prophylaxis utilization 
with a further 4% increase observed with multi-faceted interventions such as academic detailing.(57) A meta-
analysis of eleven non-randomized trials evaluating EMR-based decision support tools to improve inpatient VTE 
prophylaxis in surgical patients showed a 2.35 times increased odds of appropriate VTE prophylaxis being 
ordered with EMR-based decision support and a 0.78 relative risk of VTE.(58) Despite robust evidence in favor 
of EMR-based decision support in the inpatient setting, this approach has not been applied to post-discharge 
VTE prophylaxis in surgical patients. Educational interventions to improve prescription of ePpx have shown 
promise but have been limited to small, single institution studies.(59-61)  
 
B.7. Innovation. The proposed research program is aligned with the missions of the National Cancer Institute 
(NCI) Division of Cancer Control and Population Sciences, NCI Center to Reduce Cancer Health Disparities, and 
National Institute on Minority Health and Health Disparities (NIMHD). It is highly innovative in the following ways:  
1. The proposed multi-site RCT represents a novel application of an EMR-based CDSS aimed at improving 
utilization of ePpx after abdominopelvic cancer surgery. This will be the first stakeholder informed 
intervention in a broad surgical oncology population and the first to have an underlying theoretical 
framework. This intervention has the potential to be deployed across the Accrual to Clinical Trials (ACT) 
network, an existing clinical trial infrastructure, as part of an extramural grant.  
2. This trial will be the first to evaluate the utilization of ePpx from a health equity perspective. The patient 
population of South Carolina (SC), described in detail below, is unique in its large proportion of Black, rural, 
and economically disadvantaged patients, populations which have been significantly underrepresented in 
the surgical literature to date. Although the SC population is unique, it has the potential to provide 
generalizable data for use in improving the care of vulnerable populations in a wide variety of settings. 
 
C.1. Preliminary Data. Our multi-disciplinary research team has a strong track record of collaboration in health 
equity research. Drs. Curran and Ford published on the association of tumor microenvironment immune 
signatures with racial disparities in colon cancer.(14) In Dr. Curran’s role as the MUSC surgical lead for the South 
Carolina Surgical Quality Collaborative (SC SQC), for which Dr. Mauldin is the data lead, Dr. Curran led a study 
that showed an association with improvement in racial disparities in surgical morbidity over time across the SC 
SQC.(13) Drs. Ford and Lenert have implemented a statewide genomic screening initiative across the diverse 
SC population, (62, 63) and Drs. Lenert and Mauldin have evaluated the role of a health information exchange to 
improve emergency department care of patients in SC.(64, 65)  
 
In an abstract recently submitted to the American Society of Colon and Rectal Surgeons Annual meeting and in 
preparation for publication, Drs. Curran and Mauldin characterized the utilization of ePpx after abdominopelvic 
cancer surgery at MUSC Charleston from 2014 to 2021. In 3,874 patients, we identified an overall guideline 
concordant utilization rate of 22.9% which is consistent with published data as above. On multivariable logistic 
regression, we noted that Black race (OR 0.79; 95%CI: 0.65-0.96), as compared to White race, and poverty (OR: 
0.77; 95CI: 0.64-0.93) were independently associated with non-receipt of ePpx. Among colorectal cancer patients, 
rural patients were less likely to receive ePpx (OR: 0.70; 95%CI: 0.50-0.97). Dr. Curran has also been awarded 
a pilot grant through the American Cancer Society to evaluate racial disparities in ePpx using national 
Surveillance, Epidemiology, and End Results (SEER)/Medicare data. Unpublished preliminary analysis of these 
data shows poor adherence to guidelines with only five percent of colorectal cancer patients receiving a 
prescription for ePpx from 2016 to 2019. While the SEER/Medicare analysis is ongoing, these institutional data 
suggest the presence of disparities with the potential for amelioration through focused intervention.  
 
Seeking to augment both the training and intervention aspects of the mentorship team, Dr. Curran has recently 
collaborated with Drs. Phillips, Lenert and Deshmukh. Dr. Phillips has specific expertise in identification of barriers 
and facilitators to guideline-based care in sickle cell disease, which has directly informed the development of 

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Aims 1 and 2.2.(66) Dr. Lenert is the PI of a U01 award to pioneer an EMR-based CDSS to identify cases of 
opioid overdose and improve emergency department physician adherence to guideline-based naloxone 
adherence. The CDSS improved prescription of naloxone 4-fold at MUSC,(67) and will now be deployed to four 
centers as part of the U01 funded RCT. This experience in EMR-based CDSS will be leveraged to complete Aim 
2.1. Dr. Deshmukh’s expertise in trial design and data analytics demonstrated in a diverse anal cancer population 
will add further depth to the mentorship team. Dr. Curran’s clinical and research expertise as a surgeon paired 
with the mentorship of this talented multi-disciplinary team makes him uniquely qualified to conduct the work 
described here.   
 
D. RESEARCH DESIGN & METHODS 
D.1. Overview and Conceptual Model. The over-arching goal of this research is to improve the utilization of 
ePpx following abdominopelvic cancer surgery and mitigate observed disparities. As put forward by the NIMHD 
Research Framework, multiple domains and levels of 
influence may be implicated in disparate health outcomes (Figure D1).(68) With that in mind, barriers and 
facilitators of ePpx may exist among surgeons and patients that are not forthcoming from clinical data and these 
barriers/facilitators may vary depending on the specific patient and surgeon (Aim 1). The information gleaned 
from patient and surgeon interviews will inform a multi-faceted, EMR-based CDSS trial to improve surgeon 
adherence to guideline recommended ePpx across a variety of practice settings (Aim 2.1) and educate patients 
to improve adherence (Aim 2.2).  
 
The above hypotheses will be tested through a prospective, multiple methods study including direct patient and 
surgeon interviews using purposive sampling to obtain representative perspectives. The multiple methods 
approach is advocated to maximize the effectiveness of RCTs by incorporating stakeholder feedback at the 
design and delivery phases.(16-19) The Theoretical Domains Framework (TDF) will inform the patient and 
surgeon interviews to maximize the effect of our patient and surgeon focused interventions. In a review 
evaluating the use of theory to evaluate guideline implementation among physicians, the TDF was among the 
most commonly used methods to identify barriers, select/tailor interventions, and evaluate intervention 
impact.(69) The TDF identifies 12 domains with associated component constructs and elicits questions for 
investigating the implementation of evidence-based practice.(70) The domains associated with the TDF will be 
used to inform the key informant and focus group interviews (Aim 1) by specifically identifying NIMHD-defined 
domains and levels of influence (surgeon factors, patient factors, and SSDH) associated with prescription of 
ePpx after cancer surgery. These findings will then shape the intervention deployed in Aim 2 to improve equitable 
and guideline concordant ePpx use. The intersection of the NIMHD research framework and the TDF is 
highlighted in Figure D2 above. 

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D.2. Study Setting and Data Sources.  
South Carolina. SC presents a unique opportunity to impact 
disparities in the utilization of ePpx following abdominopelvic cancer 
surgery owing to a large disadvantaged and underserved 
population. Foremost, SC has a high degree of racial/ethnic diversity 
with 28% of residents of Non-Hispanic Black race according to 2019 
US census data.(71) As of 2018, 15% of SC residents lived below 
the Federal Poverty Level (FPL) and 20% lived between 100%-
199% of the FPL, higher than the national average of 13% and 17%, 
respectively (Figure D3).(72) Further contributors to disparity 
include healthcare access, as 34% of SC residents reside in rural 
areas, which is seventeenth among US states.(73) Finally, SC ranks 
40th in the rate of uninsured nonelderly individuals (13.1%, US average 10.9%).(72) The demographics of the 
MUSC Hollings Cancer Center patients mirror the population of the state closely. 
MUSC Regional Health Network. Three of eleven MUSC hospitals routinely perform abdominopelvic cancer 
surgery. These include an urban academic tertiary care center (MUSC Charleston, 865 beds), an urban private 
hospital (MUSC Columbia Downtown, 258 beds) and a rural private hospital (MUSC Florence, 396 beds). As of 
January 2022, the entire health system adopted a common electronic medical record (EMR; Epic).  
 
D.3. Prospective study design and implementation.  
Specific Aim 2.1: Conduct a stepped-wedge randomized trial including multi-faceted surgeon focused education 
and academic detailing to evaluate the impact of an EMR-based decision support tool to increase adherence to 
ePpx guidelines at four hospitals (six clinics) within the MUSC Health system.  
 
Aim 2.1. Intervention Design and Population. Surgeons performing cancer surgery within the MUSC system 
will be identified. Patients undergoing surgery for included cancers in the four hospitals will be identified using 
inclusion/exclusion criteria as follows. “Abdominopelvic cancer surgery” includes esophagectomy, gastrectomy, 
pancreatectomy, small bowel resection, colectomy, proctectomy, cystectomy, nephrectomy and hysterectomy / 
oophorectomy performed for a diagnosis of cancer as identified by Current Procedural Terminology (CPT) 
code and International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code. See Appendix 1 for 
code listings. We will exclude patients receiving preoperative therapeutic anticoagulation within 30 days 
preoperatively, patients initiating therapeutic anticoagulation postoperatively and patients with chronic kidney 
disease grade 3 or higher. Patients with postoperative length of stay 30 days or greater will be excluded as 
ePpx duration is for 30 days postoperative. 
 
Human Subjects Involvement, Characteristics, and Design 
 
Aim 2.1. Surgeons performing the relevant surgical oncology operations at the four sites within the MUSC 
Enterprise will be the focus of the multi-faceted educational intervention.  
 
Recruitment. 
Specific Aim 2.1. Surgeons performing cancer surgery within the MUSC Enterprise will be identified. There are 
approximately 30 surgeons across the 3 identified sites who routinely perform the relevant oncologic operations. 
The surgeon focused intervention will involve a combination of: (1) small group education at multi-disciplinary 
tumor board; (2) on-site academic detailing performed by the PI; and (3) an EMR-based CDSS. Academic 
detailing has been advocated by the Agency for Healthcare Research and Quality, and will be conducted in 
accordance with expert consensus best practices. Interventions 1-3 will take place during the one month 
transition period during of the stepped wedge study design. Surgeon re-engagement will take place at 3-month 
intervals via presentations at presentations at multi-disciplinary tumor board or individually.   
 
Retention. 
Specific Aim 2.1. Surgeon engagement will occur through regularly occurring Departmental activities including 
morbidity and mortality conference and multi-disciplinary tumor board. Attendance at these meetings are an 
integral part of surgeon clinical and academic responsibilities. Attendance at these events is monitored by the 

9 
 
department via pre-existing processes. Individual engagement may occur as needed for those surgeons not 
participating in the above conferences. The electronic medical record is necessarily used in all aspects of patient 
care and as a result, all providers performing clinical care of included patients will be exposed to the electronic 
medical record based clinical decision support system.  
 
Aim 2.1. Intervention. The surgeon focused intervention will involve a combination of: (1) small group 
education at multi-disciplinary tumor board; (2) on-site academic detailing performed by the PI; and (3) an 
EMR-based CDSS. Academic detailing has been advocated by the Agency for Healthcare Research and 
Quality,(77) and will be conducted in accordance with expert consensus best practices.(78) The educational 
intervention will be specifically tailored to address barriers identified in Aim 1 (i.e., risks, benefits of ePpx) 
and/or leverage facilitators. As noted above, Dr. Lenert has pioneered an EMR-based CDSS for prescription of 
naloxone in the emergency department management of opioid overdose.(67) This CDSS utilized a novel two-
step non-interruptive approach  1) insertion of a reminder to access a template for documentation of 
emergency department-based opioid overdose care into providers’ notes based on the patient’s chief 
complaint, and 2) a corresponding documentation template for the overdose care, that when inserted into the 
note, provided support to help providers capture critical aspects of the history, physical exam, and to take 
actions to mitigate future risk. Dr.  Lenert has collaborated with Dr. Curran to develop the CDSS, which will be 
automatically triggered by the patient’s cancer diagnosis and surgical procedure. On postoperative day 1, the 
progress note will automatically incorporate the Caprini model for VTE risk stratification into the assessment 
and plan portion of the note.(30) The risk stratification will be used to recommend guideline based strategies 
for pharmacologic ePPx which may be utilized at the discretion of the clinician. A second notification will occur 
at the “medication reconciliation” portion of the discharge process with a remind of the patient’s Carpini model 
derived risk and a recommendation for consideration of ePPx at the discretion of the clinician. The CDSS will 
be refined by the surgeon interviews in Aim 1 to optimize the timing (i.e., at admission, discharge, etc.) and 
location(s) of the CDSS (i.e., in progress notes, discharge summary, medication reconciliation, etc.).  
 
Aim 2.1. Prospective Study Design and Data Retrieval. We will deploy the intervention described above, 
including physician education and EMR-based CDSS in a stepped wedge RCT. The five clusters (six clinics) 
within the four hospitals for randomization include (1) MUSC Florence, (2) MUSC Midlands/Lancaster, and (3) 
GI, (4) GU, and (5) GYN surgical oncology at MUSC Charleston. We propose a prospective, stepped-wedge, 
cluster RCT with an open cohort design to study the implementation of an EMR-based CDSS. The stepped-
wedge design permits all clinics to receive the intervention at some point during the study period. Each clinic 
will spend study time in the control phase before transitioning to the intervention phase, enabling the evaluation 
of the intervention within and between clinics. All clinics will begin the study in the control, or usual care, phase. 
The intervention will be  
introduced in 5 steps with 1 clinic per step at intervals of 3 months (Figure D4). The transition phase from the 
control period to the intervention period will last 1 month and provide time for rolling out the education and 
EMR CDSS access. A computer-generated randomization program will assign clinics to one of the 5 pre-
defined transition steps (months 7, 10, 13, 16, and 19). Clinicians implementing the intervention cannot be 
blinded to the clinic’s assignment group, but the extraction outcome measures will be performed by the study 
team blinded to the intervention groups. Only the statistical programmer on the study will be unblinded to the 
outcomes. 
 

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Primary outcome: The primary outcome will be the proportion of patients prescribed ePpx at discharge. This 
will be assessed at the clinic level. Patients receiving a postoperative prescription for LMWH, the standard 
ePpx, or apixaban, an alternative ePpx, will be identified through the EMR.  
Secondary outcome: The secondary outcomes will be (a) association of ePpx at the patient level with race and 
SSDH and (b) the rate of VTE or major bleeding at 30 and 90 days postoperative.  
 
Aim 2.1. Covariates.  
▪ 
Patient Data: Defined comorbid conditions will be retrieved from the EMR and include the components of 
the Caprini Score for risk stratification.(30) Socio-demographic information including age, sex, and 
insurance status will be retrieved. Race will be retrieved and categorized as Black/non-Black. Urban/rural 
geographic residence status will be determined using the FORHP Rural Areas crosswalk of ZIP Codes.  
Area deprivation index will be applied by zip code to assess SSDH.(79)  
▪ 
Procedural and Postoperative Data: Procedure data including procedure type by CPT code, operative time, 
length of stay, and postoperative complications will be retrieved from EMR. 
 
Aim 2.1. Statistical analysis. Univariate analyses with 
descriptive statistics and frequency distributions will be 
calculated for patient and clinic variables and primary 
implementation outcomes. Counts and proportions of eligible 
patients in each clinic receiving the EMR tool will be calculated 
for adoption outcomes. All variables will be compared between 
unexposed control periods and exposed intervention periods. 
The intent-to-treat (ITT) population, comprising all eligible 
patients according to randomized clinic crossover time (from 
control phase to intervention phase of the study), regardless of 
the availability of outcome data, will be used for the analyses.  
We will develop multivariable regression models using a 
generalized linear mixed modeling (GLMM) framework to 
evaluate the association of the intervention with outcomes while 
adjusting for potentially confounding covariates. Predictors will 
be pre-specified and include patient age, sex, race, and 
comorbidities. We will also choose variables using clinical relevance and results from the descriptive univariate 
analyses. We will use GLMM with random effects to account for the correlation between individuals within the 
same clinic). The GLMM will account for confounders and interaction terms producing robust estimates. We 
will include an interaction term between the intervention and race indicator to be followed by an interaction 
term of the intervention with the SSDH indicator. We will also use Generalized Estimating Equations (GEE) for 
additional analyses as GEE can handle normal or non-normal endpoints and GEE can be more robust than 
GLMM to misspecification of the variance structure since “sandwich” type variance estimates are used. Models 
will be assessed for collinearity and goodness of fit using residual analysis. Additional model diagnostics will be 
performed using SAS tools that detect outliers and influential data points. We will examine variance inflation 
factor (VIF) by checking if VIF >5 which implies collinearity and predictive accuracy (measured by the 
concordance index/c-statistics).  Significance will be determined at the 0.05 level, and SAS 9.4 (SAS, Cary, 
NC) will be used for the statistical programming. 
 
Aim 2.1. Sample Size and Power. Sample size estimation for stepped-wedge trials was performed using the 
SWSamp RPackage. We based the sample size on a binary outcome of the proportion of patients prescribed 
ePpx at discharge. Our preliminary data demonstrate that 22.9% of patients with abdominopelvic cancer 
surgery have been prescribed ePpx at discharge. We expect to increase the proportion of patients with 
prescribed ePpx at discharge from 22.9%% to 50% based on effect sizes for prior studies noted in section C6. 
We computed the power using the following assumptions: an intra-cluster correlation (ICC) of 0.10; type-I error 
of 5%. Given these, for a total of 5 clusters (clinics) transitioned from control to intervention at each of the 5 
steps, the total sample size required to provide at least an 80% likelihood of detecting a 27% difference is 7.5 
patients per step per cluster (clinic), or a total of 37.5 patients per clinic during the intervention period (Figure 

11 
 
D5). This amounts to a total of 188 study patients. Based on our institutional audit, each clinic has monthly 
volumes in excess of this threshold.  
 
Specific Aim 2.2: Evaluate the impact of dedicated VTE related pre-discharge education on patient adherence 
to ePpx via a pre-post study of patients undergoing abdominopelvic cancer surgery at four hospitals within the 
MUSC Health system.  
Aim 2.2. Intervention and Population. Utilizing the insights gained in Aim 1, a one-page education sheet will 
be created to educate patients on the risks of VTE and importance of ePpx. This will be included with the 
patient’s hospital discharge information and reviewed with each patient prior to discharge by the discharge 
coordinator or nurse. This will be a pre-post study. The pre-intervention period will consist of the six months 
during which Aim 1 is taking place. The post-intervention will be after the implementation of the educational 
intervention and last 18 months. The patient population is defined in Aim 2.1. A REDCap survey will assess 
adherence to ePpx and health literacy as measured by the validated 3-item Brief Health Literacy 
Screening,(80, 81) and adverse events. 
 
Human Subjects Involvement, Characteristics, and Design 
 
Aim 2.2. Patients undergoing the relevant surgical oncology operations at the four sites within the MUSC 
Enterprise will be the focus of the patient educational intervention.  
Recruitment. 
Specific Aim 2.2. Patients will be identified prospectively using ICD-10 cancer diagnosis codes matched with 
the corresponding current procedural terminology (CPT) code. They will be a one-page education sheet will be 
created to educate patients on the risks of VTE and importance of ePpx. This will be included with the patient’s 
hospital discharge information and reviewed with each patient prior to discharge by the discharge coordinator or 
nurse. At 30-days postoperatively, patients will be sent a link to a REDCap survey via the EMR integrated 
MyChart platform or their designated, preferred email address. Patients without access to electronic 
communication may be contacted by telephone.  REDCap survey included as Appendix 2.  
 
Retention.  
 
Aim 2.2. Identification of patients meeting inclusion criteria will be automated through the EMR. Audits to assess 
accuracy of identification will be manually performed or cross referenced with an institutional cancer registry. 
Primary outcome: The primary outcome will be adherence to ePpx as assessed by REDCap survey at 30-days 
postoperative. Adherence will be defined as the percentage of days covered with treatment during the 
prescription period (i.e. duration at discharge) which has been used previously to assess ePpx.(82) This will 
include filled prescription and approximate number of doses administered out of number of doses prescribed. 
Patients without access to electronic mail will be contacted by telephone. 
Secondary outcomes: Patient reported reasons for non-adherence, bleeding events, or VTE.  
Aim 2.1. Covariates. These are as defined in Aim 2.1. 
Aim 2.1. Statistical analysis. We will compare the proportion of patient’s adherent to ePpx before and after 
the educational intervention. Sub-group analyses will compare adherence by procedure, sociodemographic 
characteristics, health literacy, and SSDH. Proportions will be compared using Fisher’s exact test.  
Aim 2.2 Sample Size & Power. Prior estimates in the orthopedic, gynecologic oncology and urologic oncology 
populations demonstrated ePpx adherence of 75% to 85%.(20, 21, 82) Assuming a baseline adherence rate of 
80%, a sample size of 199 patients in each group would provide 80% power at a type I error rate of 5% to 
detect an improvement in adherence to 90%. Assuming a survey response rate of 40%, our monthly volume of 
over 50 surgical oncology patients per month should provide adequate power to identify a difference in our 
primary outcome. Sub-group analyses will be exploratory in nature.  
Study Procedures and Materials 
 
D.4. Limitations, Alternative Approaches.  
Aim 2.1. The ability of the CDSS to algorithmically identify appropriate surgical oncology patients will be assessed 
via comparison with an institutional cancer registry. 
 

12 
 
Aim 2.2. Survey response may be lower than expected and responders may be non-representative. This can be 
addressed by comparison of respondents to overall demographics and targeted outreach. 
 
E. DATA MANAGEMENT 
Participant Screening and Enrollment. All data will be entered into an electronic study database. Designated 
research staff will collect, gather, and enter required data from the EMR (Aim 2.1: demographics, clinical data) 
and study surveys (Aim 2.2) onto study data forms. The collected data will be helpful in examining the patient 
population and feasibility of enrollment criteria and will include gender, age, race and reason for exclusion. All 
dates will be shifted and other Personal Health Information (PHI) will be removed from the study database upon 
study completion. All data obtained from this study will be used for research purposes only and will comply with 
Federal HIPAA regulations. Master Screening and Enrollment Logs will be maintained electronically and will be 
used to prepare reports. 
 
Data Security. Ensuring data security, compliance with 45 CFR 46 and maintaining the integrity of PHI is a top 
priority. MUSC has Standard Operating Procedures (SOP) to ensure a high level of data security while 
coordinating electronic and paper data management activities for clinical research trials. This study will use 
Research Electronic Data Capture (REDCap) for data capture and management. REDCap is a software toolset 
and workflow methodology for the electronic collection and management of research and clinical trials data. 
REDCap provides secure, web-based, flexible applications, including real-time validation rules with automated 
data type and range checks at the time of data entry. Exports are made available for several statistical packages 
including SPSS, SAS, SATA, R and Microsoft Excel. The study-specific REDCap electronic database will be 
designed and developed by the data manager. The provision of REDCap is made available through the South 
Carolina Clinical & Translational Research (SCTR) Institute at MUSC with NIH Grant awards UL1RR029882 and 
UL1TR000062. The REDCap study database will be hosted in the Biomedical Informatics secure data center at 
MUSC, a secure environment for data systems and servers on campus, and includes firewall, redundancy, 
failover capability, backups and extensive security checks. The secure data center has strict access control; only 
authorized core personnel may access the facility un-escorted. Only authorized users are allowed to connect to 
the network, and the security of the network is actively monitored. Power and environmental controls have 
several layers of backups, from interruptible power supplies to alternate and redundant feeds to the local utility 
company. The REDCap system administrator contributes to the maintenance of institutional disaster recovery 
and business continuity plans. Load balancers and a highly fault tolerant SAN infrastructure contribute to high 
availability. The REDCap system itself has several additional layers of protection including password protection. 
Access to the data and its security is managed institutionally by sponsored login IDs through a Shibboleth login 
with an MUSC issued NetID and features a user account management filter that controls who can access the 
data and to what degree. All personnel must pass an employment background check before being issued an ID. 
Data Entry. Only MUSC IRB approved study personnel that are authorized to have access to the REDCap study 
database will be granted password access. Study personnel using computers that are connected to the Internet 
will directly enter data into the remotely housed database. As such, no electronic study data will be stored on 
hard drives and/or any portable electronic devices. Additionally, all personnel with access to the database will 
have current University of Miami CITI training in the Conduct of Human Subject Protections, and their respective 
institution’s HIPAA and Information Security trainings that are completed annually. Each participant will be 
assigned a unique study identifier, all PHIs will be masked, and data exports will be limited to the study team for 
generating reports and the conduct of statistical data analysis. 
 
F. PROTECTION OF HUMAN SUBJECTS 
 
1. RISKS TO THE SUBJECTS 
 
a. Human Subjects Characteristics 
 
Aim 2.1. Surgeons performing the relevant surgical oncology operations at the four sites within the MUSC 
Enterprise will be the focus of the multi-faceted educational intervention.  

13 
 
 
Aim 2.2. Patients undergoing the relevant surgical oncology operations at the four sites within the MUSC 
Enterprise will be the focus of the patient educational intervention. 
 
INCLUSION OF INDIVIDUALS ACROSS THE LIFESPAN 
Aim 2.1. All surgeons and hospital-based providers are adults.  There will be no maximum age. 
 
Aim 2.2. Adult patients (ages 18 and over) will be eligible to receive the survey. Children and adolescents under 
the age of 18 are excluded from this study because these cancers are rare in children. There will be no maximum 
age.  
 
INCLUSION OF WOMEN AND MINORITIES 
Planned Distribution of Subjects by Sex/Gender, Race, and Ethnicity 
Aim 2.1. Surgeons and hospital-based providers have pre-established profile according to sex/gender, race and 
ethnicity.  We will work to engage all surgical oncologists and team members performing the relevant surgical 
procedures. 
 
Aim 2.2. The source of recruitment will be from the Medical University of South Carolina (MUSC) patient 
population. The strengths of MUSC catchment area relate to the ability to recruit Black, white, and Hispanic 
participants. We anticipate a slightly higher distribution of females (60%) given that patients with uterine and 
ovarian cancers are eligible for inclusion. The primary source of recruitment will be from the MUSC-Charleston 
which serves as the major statewide tertiary care oncology facility. The inclusion of smaller regional hospitals 
recently added to the MUSC network will facilitate recruitment of a more geographically diverse cohort. This will 
also increase the generalizability of the study through added representation of care in the community setting.  
 
MUSC: Catchment Area and Population Served 
MUSC serves the entire state of South Carolina. The racial composition of the MUSC catchment area is 68% 
White, 27% Black/Africa American, Mixed Race 2%; 1% Native American, <1% Asian; the ethnic composition is 
6% Latin-X/Hispanic. There are socioeconomic and complex cultural, geographic and potentially biological 
factors related to cancer incidence, diagnosis, and surgical outcomes. Among all South Carolinians, up to 75 
percent of new cancer cases and cancer deaths are caused by preventable factors such as tobacco use, poor 
diet, lack of exercise and limited access to health care. South Carolina leads the Nation in cancer disparities. 
 
2. Potential Risks 
Aim 2.1. The intervention directed toward surgical oncology providers within the MUSC health system includes 
education regarding current standard of care practice and an electronic medical record clinical decision support 
system intended to improve adherence to existing standard of care practice. The only potential risks include time 
spent reviewing educational materials and inconvenience associated with the electronic medical record.  
 
Aim 2.2. Participation and response to the electronic survey is at the discretion of the patient. 
 
3. Adequacy of Protection Against Risks 
 
a. Recruitment, Informed Consent and Assent 
Aim 2.1/2.2. Given the nature of the proposed intervention, a waiver of informed consent is requested from the 
IRB.  
 
Subjects will be recruited as described above in Research Design and Methods.  
 
We will also take extensive precautions to protect the privacy of the participants. Personal health identifiers (e.g., 
name, address) will not be used to identify participants in study databases. This study will use Research 
Electronic Data Capture (REDCap) for data capture and management. REDCap is a software toolset and 
workflow methodology for the electronic collection and management of research and clinical trials data. REDCap 
provides secure, web-based, flexible applications, including real-time validation rules with automated data type 

14 
 
and range checks at the time of data entry. Exports are made available for several statistical packages including 
SPSS, SAS, SATA, R and Microsoft Excel. The study-specific REDCap electronic database will be designed 
and developed by the data manager. We will use a confidential subject identification number to identify all 
participant data in research databases and on study documents. A hard copy of the key containing each 
participant’s name, study identification number, and telephone number will be kept in a locked file cabinet until 
study procedures have been completed and the data have been checked for completeness and accuracy. At 
that time, this identifying information will be destroyed. Thus, we will retain no identifying information in the study 
data files. Moreover, all computerized study databases for questionnaire data will be housed on a secure, 
password-protected network server. All personal contact information will be kept in a database that will be housed 
separately from the database containing questionnaire data. There will be limited access to study files and study 
databases throughout the duration of the study; only pertinent study staff will have access to study information. 
Securing of participant identifying information will be accomplished through several means. All study documents 
including screeners, consents, assessments and call logs will be kept in a locked file cabinet in a locked office. 
 
b. Protections Against Risk 
 
The data management system for the proposed research will be designed to achieve the major elements of the 
study including: (1) determination of study eligibility, (2) monitoring recruitment and accrual, (3) generation of 
study materials, and (4) storage of data from survey responses. This type of system has been developed as part 
of Dr. Ford’s previous studies and we will use these existing data management systems as the model for 
developing the data management system for the proposed study. All data collected as part of this study will be 
stored on a secure password-protected network server. Moreover, access to the server will be monitored by the 
PI and limited to pertinent study personnel. 
 
Protection against Adverse Reactions. As described above, study data will be entered into research 
databases using a confidential subject identification number. 
 
Handling Incidental Findings and Adverse Effects. In the event of any unexpected events related to incidental 
findings, safety concerns, and adverse effects, the PIs and/or study staff will contact the MUSC IRB (IRB of 
record) to discuss appropriate action. 
 
c. Vulnerable Subjects 
Pregnant Women, Fetuses, and Neonates or Children. This study does not involve the recruitment of children 
or the collection of specimens from fetuses or neonates. As the educational interventions are at the surgeon-
level, there are no additional risks posed to pregnant women. 
 
Prisoners. This study does not involve the recruitment of prisoners. 
 
4. Potential Benefits of the Proposed Research to Research Participants and Others 
Aim 2.1 of the study has the potential to benefit the participating surgeons by educating them on existing 
evidence-based guidelines related to extended VTE prophylaxis after abdominopelvic cancer surgery. The 
patients treated by these providers may also benefit by improving the likelihood of extended VTE prophylaxis, a 
treatment with demonstrated benefit in Level 1 evidence. The potential risks associated with study participation 
are minimal. Aim 2.2 has the potential to benefit patients by receiving education related to blood clot recognition 
and prevention after abdominopelvic cancer surgery (the intervention). The risks of survey response are minimal. 
 
5. Importance of Knowledge to be Gained 
Venous thromboembolism (VTE) following major cancer surgery is a significant contributor to patient morbidity 
and mortality. Extended VTE prophylaxis following major cancer surgery has been shown to decrease the risk 
of post-hospital VTE and is recommended by a number of professional societies. However, utilization of 
extended VTE prophylaxis remains limited. Moreover, racial disparities exist for cancer associated outcomes 
such as morbidity, including VTE, and mortality. These inequities in broader cancer care and the lack of guideline 
concordant care for Black patients suggests that disparities may exist related to the utilization of extended VTE 
prophylaxis as well. Indeed, this aspect of cancer care has not been studied through a lens of cancer health 

15 
 
disparities. The reasons for low utilization have not been forthcoming from existing data and remain a significant 
knowledge gap; a gap we intend to bridge with the proposed study. The application of rigorous qualitative 
research methodology to this clinical context will elucidate mechanisms to improve administration of guideline 
concordant extended VTE prophylaxis. Pairing these data with validated intervention development methodology, 
the intervention implemented through this work has the potential to significantly impact cancer care and mitigate 
cancer health disparities. 
 
The proposed work also opens the door for the principal investigator to pursue future cancer health equity 
focused interventions. This methodology may be used to improve adherence to guideline concordant care across 
the continuum of cancer care in light of previously noted racial disparities in guideline concordant treatment. The 
methodology and lessons learned in this work will inform the investigator’s K23 grant proposal to evaluate cancer 
care guideline concordance within a multi-center clinical trial by an equity focused, multiple methods 
intervention.  
 
Data and Safety Monitoring Plan 
 
Aim 2.1, 2.2: Considering the study rationale, population, procedures, and the risk benefit profile, the overall risk 
level for participation in this study is classified as: Minimum risk. 
 
K. REFERENCES 
1. 
Curran T, Tulin-Silver S, Patel K, Ward S, Schneiderman M, Harpaz N, Schwartz M, Itzkowitz S, 
Warner RR, Kim MK. Prognostic clinicopathologic factors in longitudinally followed patients with metastatic 
small bowel carcinoid tumors. Pancreas. 2011;40(8):1253-7. Epub 2011/10/07. doi: 
10.1097/MPA.0b013e318225483c. PubMed PMID: 21975435. 
2. 
Warner RR, Curran T, Shafir MK, Schiano TD, Khaitova V, Kim MK. Serum and ascites chromogranin-
A in patients with metastatic neuroendocrine tumors. Pancreas. 2011;40(4):622-6. Epub 2011/04/13. doi: 
10.1097/MPA.0b013e3182156c0b. PubMed PMID: 21483253. 
3. 
Curran T, Zhang JQ, Lo RC, Fokkema M, McCallum JC, Buck DB, Darling J, Schermerhorn ML. Risk 
factors and indications for readmission after lower extremity amputation in the American College of Surgeons 
National Surgical Quality Improvement Program. J Vasc Surg. 2014;60(5):1315-24. Epub 2014/07/06. doi: 
10.1016/j.jvs.2014.05.050. PubMed PMID: 24985536; PMCID: PMC4254086. 
4. 
Schermerhorn ML, Buck DB, O'Malley AJ, Curran T, McCallum JC, Darling J, Landon BE. Long-Term 
Outcomes of Abdominal Aortic Aneurysm in the Medicare Population. N Engl J Med. 2015;373(4):328-38. 
Epub 2015/07/23. doi: 10.1056/NEJMoa1405778. PubMed PMID: 26200979; PMCID: PMC4532303. 
5. 
Zhang JQ, Curran T, McCallum JC, Wang L, Wyers MC, Hamdan AD, Guzman RJ, Schermerhorn ML. 
Risk factors for readmission after lower extremity bypass in the American College of Surgeons National 
Surgery Quality Improvement Program. J Vasc Surg. 2014;59(5):1331-9. doi: 10.1016/j.jvs.2013.12.032. 
PubMed PMID: 24491239; PMCID: 4004644. 
6. 
Curran T, Poylin V, Nagle D. Real world dehiscence rates for patients undergoing abdominoperineal 
resection with or without myocutaneous flap closure in the national surgical quality improvement project. 
International journal of colorectal disease. 2016;31(1):95-104. Epub 2015/09/01. doi: 10.1007/s00384-015-
2377-5. PubMed PMID: 26315016. 
7. 
Booth A, Leo MD, Kovacs M, Maxwell PJ, Donahue C, George VV, Curran T. Preoperative small bowel 
dilation is associated with ileus after right colectomy. Surgery in Practice and Science. 2022:100109. doi: 
https://doi.org/10.1016/j.sipas.2022.100109. 
8. 
Booth AT, Curran T. Preoperative optimization and enhanced recovery for colorectal surgery. Seminars 
in Colon and Rectal Surgery. 2021;32(3):100827. doi: https://doi.org/10.1016/j.scrs.2021.100827. 
9. 
Booth AT, Gillen KJ, Visintin I, Ford WF, Kovacs MD, Edgerton CA, George VV, Curran T. Diastasis 
recti is associated with incisional hernia after midline abdominal surgery. Hernia. 2022. Epub 2022/09/23. doi: 
10.1007/s10029-022-02676-w. PubMed PMID: 36136228. 
10. 
Booth AT, Allen S, Simianu VV, Jensen CC, Schermerhorn ML, George VV, Curran T. Selective type & 
screen for elective colectomy based on a transfusion risk score may generate substantial cost savings. Surg 
Endosc. 2022;36(12):8817-24. Epub 2022/05/27. doi: 10.1007/s00464-022-09307-6. PubMed PMID: 
35616730. 

16 
 
11. 
Booth A, Ford W, Brennan E, Magwood G, Forster E, Curran T. Towards Equitable Surgical 
Management of Inflammatory Bowel Disease: A Systematic Review of Disparities in Surgery for Inflammatory 
Bowel Disease. Inflammatory bowel diseases. 2021. Epub 2021/09/24. doi: 10.1093/ibd/izab237. PubMed 
PMID: 34553754. 
12. 
Booth A, Ford W, Olajire-Aro T, George V, Curran T. Fever After Colectomy in the Enhanced Recovery 
Era: Incidence and Risk Factors for Pathologic Source. The Journal of surgical research. 2022;277:171-80. 
Epub 2022/05/03. doi: 10.1016/j.jss.2022.04.024. PubMed PMID: 35500512. 
13. 
Curran T, Zhang J, Gebregziabher M, Taber DJ, Marsden JE, Booth A, Magwood GS, Mauldin PD, 
Baliga PK, Lockett MA. Surgical Outcomes Improvement and Health Inequity in a Regional Quality 
Collaborative. Journal of the American College of Surgeons. 2022;234(4):607-14. doi: 
10.1097/xcs.0000000000000084. PubMed PMID: 00019464-202204000-00024. 
14. 
Curran T, Sun Z, Gerry B, Findlay VJ, Wallace K, Li Z, Paulos C, Ford M, Rubinstein MP, Chung D, 
Camp ER. Differential immune signatures in the tumor microenvironment are associated with colon cancer 
racial disparities. Cancer Med. 2021. Epub 2021/02/10. doi: 10.1002/cam4.3753. PubMed PMID: 33560598. 
15. 
Panetta CR, Curran T. Extended Venous Thromboembolism Prophylaxis Following Colorectal Cancer 
Resection. Dis Colon Rectum. 2022;65(9):1079-82. Epub 2022/07/20. doi: 10.1097/DCR.0000000000002543. 
PubMed PMID: 35853185. 
16. 
O'Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for 
randomised controlled trials? A systematic mapping review. BMJ Open. 2013;3(6). Epub 2013/06/26. doi: 
10.1136/bmjopen-2013-002889. PubMed PMID: 23794542; PMCID: PMC3669723. 
17. 
O'Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, Adamson J, Jansen YJ, Mills N, Moore G, 
Donovan JL. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: 
guidance for researchers. Pilot Feasibility Stud. 2015;1:32. Epub 2015/09/07. doi: 10.1186/s40814-015-0026-y. 
PubMed PMID: 27965810; PMCID: PMC5154038. 
18. 
Husbands S, Caskey F, Winton H, Gibson A, Donovan JL, Rooshenas L. Pre-trial qualitative work with 
health care professionals to refine the design and delivery of a randomised controlled trial on kidney care. 
Trials. 2019;20(1). doi: 10.1186/s13063-019-3281-z. 
19. 
Aschbrenner KA, Kruse G, Gallo JJ, Plano Clark VL. Applying mixed methods to pilot feasibility studies 
to inform intervention trials. Pilot Feasibility Stud. 2022;8(1):217. Epub 2022/09/27. doi: 10.1186/s40814-022-
01178-x. PubMed PMID: 36163045; PMCID: PMC9511762. 
20. 
Westerman ME, Bree KK, Msaouel P, Kukreja JB, Mantaring C, Rukundo I, Gonzalez MG, Gregg JR, 
Casteel KN, Matin SF. Apixaban vs Enoxaparin for Post-Surgical Extended-Duration Venous Thromboembolic 
Event Prophylaxis: A Prospective Quality Improvement Study. J Urol. 2022;208(4):886-95. Epub 2022/09/10. 
doi: 10.1097/JU.0000000000002788. PubMed PMID: 36082549. 
21. 
Guntupalli SR, Brennecke A, Behbakht K, Tayebnejad A, Breed CA, Babayan LM, Cheng G, Ramzan 
AA, Wheeler LJ, Corr BR, Lefkowits C, Sheeder J, Matsuo K, Flink D. Safety and Efficacy of Apixaban vs 
Enoxaparin for Preventing Postoperative Venous Thromboembolism in Women Undergoing Surgery for 
Gynecologic Malignant Neoplasm: A Randomized Clinical Trial. JAMA Netw Open. 2020;3(6):e207410. Epub 
2020/06/27. doi: 10.1001/jamanetworkopen.2020.7410. PubMed PMID: 32589230; PMCID: PMC7320298. 
22. 
Chew HK, Wun T, Harvey D, Zhou H, White RH. Incidence of venous thromboembolism and its effect 
on survival among patients with common cancers. Arch Intern Med. 2006;166(4):458-64. Epub 2006/03/01. 
doi: 10.1001/archinte.166.4.458. PubMed PMID: 16505267. 
23. 
Agnelli G, Bolis G, Capussotti L, Scarpa RM, Tonelli F, Bonizzoni E, Moia M, Parazzini F, Rossi R, 
Sonaglia F, Valarani B, Bianchini C, Gussoni G. A clinical outcome-based prospective study on venous 
thromboembolism after cancer surgery: the @RISTOS project. Ann Surg. 2006;243(1):89-95. Epub 
2005/12/24. doi: 10.1097/01.sla.0000193959.44677.48. PubMed PMID: 16371741; PMCID: PMC1449979. 
24. 
Caprini JA. Risk assessment as a guide for the prevention of the many faces of venous 
thromboembolism. Am J Surg. 2010;199(1 Suppl):S3-10. Epub 2010/02/05. doi: 
10.1016/j.amjsurg.2009.10.006. PubMed PMID: 20103082. 
25. 
Mallick S, Aiken T, Varley P, Abbott D, Tzeng CW, Weber S, Wasif N, Zafar SN. Readmissions From 
Venous Thromboembolism After Complex Cancer Surgery. JAMA Surg. 2022. Epub 2022/01/27. doi: 
10.1001/jamasurg.2021.7126. PubMed PMID: 35080619. 
26. 
Cohoon KP, Ransom JE, Leibson CL, Ashrani AA, Petterson TM, Long KH, Bailey KR, Heit JA. Direct 
Medical Costs Attributable to Cancer-Associated Venous Thromboembolism: A Population-Based Longitudinal 

17 
 
Study. The American journal of medicine. 2016;129(9):1000 e15-25. Epub 2016/03/26. doi: 
10.1016/j.amjmed.2016.02.030. PubMed PMID: 27012853; PMCID: PMC4996698. 
27. 
Cohoon KP, Leibson CL, Ransom JE, Ashrani AA, Park MS, Petterson TM, Long KH, Bailey KR, Heit 
JA. Direct medical costs attributable to venous thromboembolism among persons hospitalized for major 
operation: a population-based longitudinal study. Surgery. 2015;157(3):423-31. Epub 2015/01/31. doi: 
10.1016/j.surg.2014.10.005. PubMed PMID: 25633736; PMCID: PMC4346535. 
28. 
Lee AY, Levine MN. Venous thromboembolism and cancer: risks and outcomes. Circulation. 
2003;107(23 Suppl 1):I17-21. Epub 2003/06/20. doi: 10.1161/01.CIR.0000078466.72504.AC. PubMed PMID: 
12814981. 
29. 
Anderson FA, Jr., Spencer FA. Risk factors for venous thromboembolism. Circulation. 2003;107(23 
Suppl 1):I9-16. Epub 2003/06/20. doi: 10.1161/01.CIR.0000078469.07362.E6. PubMed PMID: 12814980. 
30. 
Bahl V, Hu HM, Henke PK, Wakefield TW, Campbell DA, Jr., Caprini JA. A validation study of a 
retrospective venous thromboembolism risk scoring method. Ann Surg. 2010;251(2):344-50. Epub 2009/09/26. 
doi: 10.1097/SLA.0b013e3181b7fca6. PubMed PMID: 19779324. 
31. 
Merkow RP, Bilimoria KY, McCarter MD, Cohen ME, Barnett CC, Raval MV, Caprini JA, Gordon HS, 
Ko CY, Bentrem DJ. Post-discharge venous thromboembolism after cancer surgery: extending the case for 
extended prophylaxis. Ann Surg. 2011;254(1):131-7. Epub 2011/04/30. doi: 10.1097/SLA.0b013e31821b98da. 
PubMed PMID: 21527843. 
32. 
Fleming FJ, Kim MJ, Salloum RM, Young KC, Monson JR. How much do we need to worry about 
venous thromboembolism after hospital discharge? A study of colorectal surgery patients using the National 
Surgical Quality Improvement Program database. Dis Colon Rectum. 2010;53(10):1355-60. Epub 2010/09/18. 
doi: 10.1007/DCR.0b013e3181eb9b0e. PubMed PMID: 20847615. 
33. 
Klaassen Z, Arora K, Goldberg H, Chandrasekar T, Wallis CJD, Sayyid RK, Fleshner NE, Finelli A, 
Kutikov A, Violette PD, Kulkarni GS. Extended Venous Thromboembolism Prophylaxis after Radical 
Cystectomy: A Call for Adherence to Current Guidelines. J Urol. 2018;199(4):906-14. Epub 2017/11/09. doi: 
10.1016/j.juro.2017.08.130. PubMed PMID: 29113840. 
34. 
Barber EL, Gehrig PA, Clarke-Pearson DL. Venous Thromboembolism in Minimally Invasive Compared 
With Open Hysterectomy for Endometrial Cancer. Obstet Gynecol. 2016;128(1):121-6. Epub 2016/06/09. doi: 
10.1097/aog.0000000000001492. PubMed PMID: 27275805; PMCID: PMC4917445. 
35. 
Rasmussen MS, Jorgensen LN, Wille-Jorgensen P. Prolonged thromboprophylaxis with low molecular 
weight heparin for abdominal or pelvic surgery. Cochrane Database Syst Rev. 2009(1):CD004318. Epub 
2009/01/23. doi: 10.1002/14651858.CD004318.pub2. PubMed PMID: 19160234. 
36. 
Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous 
thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 
2004;126(3 Suppl):338S-400S. Epub 2004/09/24. doi: 10.1378/chest.126.3_suppl.338S. PubMed PMID: 
15383478. 
37. 
Khorana AA. The NCCN Clinical Practice Guidelines on Venous Thromboembolic Disease: strategies 
for improving VTE prophylaxis in hospitalized cancer patients. Oncologist. 2007;12(11):1361-70. Epub 
2007/12/07. doi: 10.1634/theoncologist.12-11-1361. PubMed PMID: 18055857. 
38. 
Lyman GH, Khorana AA, Falanga A, Clarke-Pearson D, Flowers C, Jahanzeb M, Kakkar A, Kuderer 
NM, Levine MN, Liebman H, Mendelson D, Raskob G, Somerfield MR, Thodiyil P, Trent D, Francis CW, 
American Society of Clinical O. American Society of Clinical Oncology guideline: recommendations for venous 
thromboembolism prophylaxis and treatment in patients with cancer. J Clin Oncol. 2007;25(34):5490-505. 
Epub 2007/10/31. doi: 10.1200/JCO.2007.14.1283. PubMed PMID: 17968019. 
39. 
K.A.O. Tikkinen (Chair) RC, M.K. Gould, R. Naspro, G. Novara, P.M. Sandset, P.D. Violette, G.H. 
Guyatt. Thromboprophylaxis, panel. g. European Association of Urology Guidelines of thromboprophylaxis in 
urologic surgery 2020 [cited 2021 November 17]. Available from: 
https://uroweb.org/guideline/thromboprophylaxis/. 
40. 
Prevention of Venous Thromboembolism in Gynecologic Surgery: ACOG Practice Bulletin, Number 
232. Obstetrics & Gynecology. 2021;138(1):e1-e15. doi: 10.1097/aog.0000000000004445. PubMed PMID: 
00006250-202107000-00035. 
41. 
Fleming F, Gaertner W, Ternent CA, Finlayson E, Herzig D, Paquette IM, Feingold DL, Steele SR. The 
American Society of Colon and Rectal Surgeons Clinical Practice Guideline for the Prevention of Venous 

18 
 
Thromboembolic Disease in Colorectal Surgery. Dis Colon Rectum. 2018;61(1):14-20. Epub 2017/12/09. doi: 
10.1097/DCR.0000000000000982. PubMed PMID: 29219916. 
42. 
Felder S, Rasmussen MS, King R, Sklow B, Kwaan M, Madoff R, Jensen C. Prolonged 
thromboprophylaxis with low molecular weight heparin for abdominal or pelvic surgery. Cochrane Database 
Syst Rev. 2019;8:CD004318. Epub 2019/08/27. doi: 10.1002/14651858.CD004318.pub5. PubMed PMID: 
31449321; PMCID: PMC6709764. 
43. 
Colorectal Writing Group for Surgical C, Outcomes Assessment Program-Comparative Effectiveness 
Research Translation Network C, Nelson DW, Simianu VV, Bastawrous AL, Billingham RP, Fichera A, 
Florence MG, Johnson EK, Johnson MG, Thirlby RC, Flum DR, Steele SR. Thromboembolic Complications 
and Prophylaxis Patterns in Colorectal Surgery. JAMA Surg. 2015;150(8):712-20. Epub 2015/06/11. doi: 
10.1001/jamasurg.2015.1057. PubMed PMID: 26060977; PMCID: PMC4545402. 
44. 
Mukkamala A, Montgomery JR, De Roo AC, Ogilvie JW, Jr., Regenbogen SE. Population-Based 
Analysis of Adherence to Postdischarge Extended Venous Thromboembolism Prophylaxis After Colorectal 
Resection. Dis Colon Rectum. 2020;63(7):911-7. Epub 2020/06/05. doi: 10.1097/DCR.0000000000001650. 
PubMed PMID: 32496331; PMCID: PMC7804389. 
45. 
Ruff SM, Ayabe RI, Wach MM, Diggs LP, Martin SP, Davis JL, Hernandez JM. Practice patterns of VTE 
chemoprophylaxis after discharge following hepatic and pancreatic resections for cancer: A survey of 
hepatopancreatobiliary surgeons. J Thromb Thrombolysis. 2019;48(1):119-24. Epub 2019/03/17. doi: 
10.1007/s11239-019-01834-9. PubMed PMID: 30877618; PMCID: PMC6595222. 
46. 
Zwischenberger BA, Tzeng CW, Ward ND, Zwischenberger JB, Martin JT. Venous Thromboembolism 
Prophylaxis For Esophagectomy: A Survey of Practice Patterns Among Thoracic Surgeons. Ann Thorac Surg. 
2016;101(2):489-94. Epub 2015/09/28. doi: 10.1016/j.athoracsur.2015.07.023. PubMed PMID: 26409709. 
47. 
Lyon TD, Shah ND, Tollefson MK, Shah PH, Sangaralingham LR, Asante D, Thompson RH, Karnes 
RJ, Frank I, Boorjian SA. Trends in Extended-Duration Venous Thromboembolism Prophylaxis Following 
Radical Cystectomy. Urology. 2020;136:105-11. Epub 2019/11/13. doi: 10.1016/j.urology.2019.09.047. 
PubMed PMID: 31715273. 
48. 
Griffiths CD, Simunovic M, Gafni A, Parpia S, Linkins LA, Serrano PE. Posthospital discharge venous 
thromboembolism prophylaxis among colorectal and hepatobiliary surgeons: A practice survey. Surgery. 
2021;170(1):173-9. Epub 2021/03/20. doi: 10.1016/j.surg.2021.02.015. PubMed PMID: 33736865. 
49. 
Singh M, Datta SK, Papenfuss WA, Belini G, Chevinsky A, Weese JL. Racial disparity in 
gastrointestinal cancer: Insight from national cancer database. Journal of Clinical Oncology. 
2019;37(4_suppl):607-. doi: 10.1200/JCO.2019.37.4_suppl.607. 
50. 
Rauh-Hain JA, Melamed A, Schaps D, Bregar AJ, Spencer R, Schorge JO, Rice LW, Del Carmen MG. 
Racial and ethnic disparities over time in the treatment and mortality of women with gynecological 
malignancies. Gynecol Oncol. 2018;149(1):4-11. Epub 2018/04/02. doi: 10.1016/j.ygyno.2017.12.006. PubMed 
PMID: 29605048. 
51. 
Gild P, Wankowicz SA, Sood A, von Landenberg N, Friedlander DF, Alanee S, Chun FKH, Fisch M, 
Menon M, Trinh QD, Bellmunt J, Abdollah F. Racial disparity in quality of care and overall survival among black 
vs. white patients with muscle-invasive bladder cancer treated with radical cystectomy: A national cancer 
database analysis. Urol Oncol. 2018;36(10):469.e1-.e11. Epub 2018/08/25. doi: 
10.1016/j.urolonc.2018.07.012. PubMed PMID: 30139659. 
52. 
Poulson M, Cornell E, Madiedo A, Kenzik K, Allee L, Dechert T, Hall J. The Impact of Racial Residential 
Segregation on Colorectal Cancer Outcomes and Treatment. Ann Surg. 2020. Epub 2020/11/26. doi: 
10.1097/SLA.0000000000004653. PubMed PMID: 33234793. 
53. 
Zahnd WE, Fogleman AJ, Jenkins WD. Rural-Urban Disparities in Stage of Diagnosis Among Cancers 
With Preventive Opportunities. Am J Prev Med. 2018;54(5):688-98. Epub 2018/03/20. doi: 
10.1016/j.amepre.2018.01.021. PubMed PMID: 29550163. 
54. 
Mahajan A, Brunson A, Adesina O, Keegan TH, Wun T. The Incidence of Cancer Associated 
Thrombosis is Increasing Over Time. Blood Adv. 2021. Epub 2021/10/15. doi: 
10.1182/bloodadvances.2021005590. PubMed PMID: 34649273. 
55. 
Trinh VQ, Karakiewicz PI, Sammon J, Sun M, Sukumar S, Gervais MK, Shariat SF, Tian Z, Kim SP, 
Kowalczyk KJ, Hu JC, Menon M, Trinh QD. Venous thromboembolism after major cancer surgery: temporal 
trends and patterns of care. JAMA Surg. 2014;149(1):43-9. Epub 2013/11/08. doi: 
10.1001/jamasurg.2013.3172. PubMed PMID: 24197279. 

19 
 
56. 
Sutton RT, Pincock D, Baumgart DC, Sadowski DC, Fedorak RN, Kroeker KI. An overview of clinical 
decision support systems: benefits, risks, and strategies for success. NPJ Digit Med. 2020;3:17. Epub 
2020/02/13. doi: 10.1038/s41746-020-0221-y. PubMed PMID: 32047862; PMCID: PMC7005290. 
57. 
Kahn SR, Morrison DR, Diendere G, Piche A, Filion KB, Klil-Drori AJ, Douketis JD, Emed J, Roussin A, 
Tagalakis V, Morris M, Geerts W. Interventions for implementation of thromboprophylaxis in hospitalized 
patients at risk for venous thromboembolism. Cochrane Database Syst Rev. 2018;4:CD008201. Epub 
2018/04/25. doi: 10.1002/14651858.CD008201.pub3. PubMed PMID: 29687454; PMCID: PMC6747554. 
58. 
Borab ZM, Lanni MA, Tecce MG, Pannucci CJ, Fischer JP. Use of Computerized Clinical Decision 
Support Systems to Prevent Venous Thromboembolism in Surgical Patients: A Systematic Review and Meta-
analysis. JAMA Surg. 2017;152(7):638-45. Epub 2017/03/16. doi: 10.1001/jamasurg.2017.0131. PubMed 
PMID: 28297002; PMCID: PMC5831455. 
59. 
Vázquez FJ, Bilbao MS, Saimovici J, Vaccaro C. Improving adherence rate of extended prophylaxis for 
venous thromboembolic disease after abdominal and pelvic oncologic surgery: a pilot educational study. Clin 
Appl Thromb Hemost. 2015;21(8):750-4. Epub 2015/04/25. doi: 10.1177/1076029615583348. PubMed PMID: 
25908111. 
60. 
Najjar PA, Madenci AL, Zogg CK, Schneider EB, Dankers CA, Pimentel MT, Chabria AS, Goldberg JE, 
Sharma G, Piazza G, Bleday R, Orgill DP, Kachalia A. Implementation of a Comprehensive Post-Discharge 
Venous Thromboembolism Prophylaxis Program for Abdominal and Pelvic Surgery Patients. J Am Coll Surg. 
2016;223(6):804-13. Epub 2016/10/04. doi: 10.1016/j.jamcollsurg.2016.09.010. PubMed PMID: 27693288; 
PMCID: PMC6309555. 
61. 
Ong CT, Leung E, Shah AP. Improving prescribing of extended prophylaxis for venous 
thromboembolism at discharge in patients who underwent surgery for colorectal cancer. Br J Hosp Med (Lond). 
2020;81(11):1-7. Epub 2020/12/03. doi: 10.12968/hmed.2020.0405. PubMed PMID: 33263480. 
62. 
Allen CG, Judge DP, Levin E, Sterba K, Hunt K, Ramos PS, Melvin C, Wager K, Catchpole K, Clinton 
C, Ford M, McMahon LL, Lenert L. A pragmatic implementation research study for In Our DNA SC: a protocol 
to identify multi-level factors that support the implementation of a population-wide genomic screening initiative 
in diverse populations. Implement Sci Commun. 2022;3(1):48. Epub 2022/04/29. doi: 10.1186/s43058-022-
00286-2. PubMed PMID: 35484601; PMCID: PMC9052691. 
63. 
Allen CG, Lenert L, Hunt K, Jackson A, Levin E, Clinton C, Clark JT, Garrison K, Gallegos S, Wager K, 
He W, Sterba K, Ramos PS, Melvin C, Ford M, Catchpole K, McMahon L, Judge DP. Lessons Learned from 
the Pilot Phase of a Population-Wide Genomic Screening Program: Building the Base to Reach a Diverse 
Cohort of 100,000 Participants. J Pers Med. 2022;12(8). Epub 2022/08/27. doi: 10.3390/jpm12081228. 
PubMed PMID: 36013178; PMCID: PMC9410232. 
64. 
Carr CM, Saef SH, Zhang J, Su Z, Melvin CL, Obeid JS, Zhao W, Arnaud JC, Marsden J, Sendor AB, 
Lenert L, Moran WP, Mauldin PD. When Should ED Physicians Use an HIE? Predicting Presence of Patient 
Data in an HIE. Southern medical journal. 2016;109(7):427-33. Epub 2016/07/02. doi: 
10.14423/SMJ.0000000000000490. PubMed PMID: 27364029; PMCID: PMC4933325. 
65. 
Saef SH, Carr CM, Bush JS, Bartman MT, Sendor AB, Zhao W, Su Z, Zhang J, Marsden J, Arnaud JC, 
Melvin CL, Lenert L, Moran WP, Mauldin PD, Obeid JS. A Comprehensive View of Frequent Emergency 
Department Users Based on Data from a Regional HIE. Southern medical journal. 2016;109(7):434-9. Epub 
2016/07/02. doi: 10.14423/SMJ.0000000000000488. PubMed PMID: 27364030; PMCID: PMC4933324. 
66. 
Phillips SM, Schlenz AM, Mueller M, Melvin CL, Adams RJ, Kanter J. Identified barriers and facilitators 
to stroke risk screening in children with sickle cell anemia: results from the DISPLACE consortium. 
Implementation Science Communications. 2021;2(1). doi: 10.1186/s43058-021-00192-z. 
67. 
Lenert LA, Zhu V, Jennings L, McCauley JL, Obeid JS, Ward R, Hassanpour S, Marsch LA, Hogarth M, 
Shipman P, Harris DR, Talbert JC. Enhancing research data infrastructure to address the opioid epidemic: the 
Opioid Overdose Network (O2-Net). JAMIA Open. 2022;5(2):ooac055. Epub 2022/07/06. doi: 
10.1093/jamiaopen/ooac055. PubMed PMID: 35783072; PMCID: PMC9243402. 
68. 
Alvidrez J, Castille D, Laude-Sharp M, Rosario A, Tabor D. The National Institute on Minority Health 
and Health Disparities Research Framework. American Journal of Public Health. 2019;109(S1):S16-S20. doi: 
10.2105/ajph.2018.304883. 
69. 
Liang L, Bernhardsson S, Vernooij RW, Armstrong MJ, Bussieres A, Brouwers MC, Gagliardi AR, 
Members of the Guidelines International Network Implementation Working G. Use of theory to plan or evaluate 

20 
 
guideline implementation among physicians: a scoping review. Implement Sci. 2017;12(1):26. Epub 
2017/03/01. doi: 10.1186/s13012-017-0557-0. PubMed PMID: 28241771; PMCID: PMC5327520. 
70. 
Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A, Psychological Theory G. Making 
psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health 
Care. 2005;14(1):26-33. Epub 2005/02/05. doi: 10.1136/qshc.2004.011155. PubMed PMID: 15692000; 
PMCID: PMC1743963. 
71. 
Bureau USC. Race alone or in combination with one or more other races—Total population—Black or 
African American—Percent 2019 [cited 2020 March 6]. Available from: 
https://data.census.gov/cedsci/map?q=population&g=0400000US01,02,04,05,06,08,09,10,11,12,13,15,16,17,1
8,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,44,45,46,47,48,49,50,51,53,54,5
5,56&tid=ACSDP1Y2019.DP05&hidePreview=false&vintage=2019&layer=VT_2019_040_00_PP_D1&cid=DP0
5_0065PE&palette=Teal&classification=Natural%20Breaks&mode=thematic. 
72. 
Foundation KF. State Health Care Snapshots: South Carolina 2020 [cited 2021 March 6]. Available 
from: https://www.kff.org/statedata/election-state-fact-sheets/south-carolina/. 
73. 
Bureau USC. 2010 Census Urban and Rural Classification and Urban Area Criteria  [cited 2021 March 
6]. Available from: https://www.census.gov/programs-surveys/geography/guidance/geo-areas/urban-
rural/2010-urban-rural.html. 
74. 
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 
2005;15(9):1277-88. Epub 2005/10/06. doi: 10.1177/1049732305276687. PubMed PMID: 16204405. 
75. 
Fereday J, Muir-Cochrane E. Demonstrating Rigor Using Thematic Analysis: A Hybrid Approach of 
Inductive and Deductive Coding and Theme Development. International Journal of Qualitative Methods. 
2006;5(1):80-92. doi: 10.1177/160940690600500107. 
76. 
Dye JF, Schatz, I. M., Rosenberg, B. A., & Coleman, S. T. . Constant Comparison Method: A 
Kaleidoscope of Data. The Qualitative Report. 2000;4(1):1-10. doi: 10.46743/2160-3715/2000.2090. 
77. 
Quality AfHRa. Module 10. Academic Detailing as a Quality Improvement Tool Rockville, MD2013 
[updated May 2013; cited 2021 11/1/21]. Available from: https://www.ahrq.gov/ncepcr/tools/pf-
handbook/mod10.html  
78. 
Yeh JS, Van Hoof TJ, Fischer MA. Key Features of Academic Detailing: Development of an Expert 
Consensus Using the Delphi Method. Am Health Drug Benefits. 2016;9(1):42-50. Epub 2016/04/12. PubMed 
PMID: 27066195; PMCID: PMC4822978. 
79. 
Brokamp C, Beck AF, Goyal NK, Ryan P, Greenberg JM, Hall ES. Material community deprivation and 
hospital utilization during the first year of life: an urban population-based cohort study. Ann Epidemiol. 
2019;30:37-43. Epub 2018/12/20. doi: 10.1016/j.annepidem.2018.11.008. PubMed PMID: 30563729; PMCID: 
PMC6370517. 
80. 
Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. 
Fam Med. 2004;36(8):588-94. Epub 2004/09/03. PubMed PMID: 15343421. 
81. 
Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines 
AD, Vanryn M. Validation of screening questions for limited health literacy in a large VA outpatient population. 
J Gen Intern Med. 2008;23(5):561-6. Epub 2008/03/13. doi: 10.1007/s11606-008-0520-5. PubMed PMID: 
18335281; PMCID: PMC2324160. 
82. 
Bergqvist D, Arcelus JI, Felicissimo P, investigators E. Post-discharge compliance to venous 
thromboembolism prophylaxis in high-risk orthopaedic surgery: results from the ETHOS registry. Thromb 
Haemost. 2012;107(2):280-7. Epub 2011/12/22. doi: 10.1160/TH11-07-0464. PubMed PMID: 22186771. 
 
 
 
 
 
 
 
 

21 
 
APPENDIX 1: Procedure/Diagnosis Codes 
 
 
Organ site 
ICD10 
Procedure 
Stomach 
C16 
43620 
Stomach 
C16 
43621 
Stomach 
C16 
43622 
Stomach 
C16 
43631 
Stomach 
C16 
43632 
Stomach 
C16 
43633 
Stomach 
C16 
43634 
Stomach 
C16 
43659 
Stomach 
C16 
96446 
Stomach 
C16 
49203 
Stomach 
C16 
49204 
Stomach 
C16 
49205 
Esophagus 
C15 
43107 
Esophagus 
C15 
43108 
Esophagus 
C15 
43112 
Esophagus 
C15 
43113 
Esophagus 
C15 
43116 
Esophagus 
C15 
43117 
Esophagus 
C15 
43118 
Esophagus 
C15 
43121 
Esophagus 
C15 
43123 
Esophagus 
C15 
43124 
Esophagus 
C15 
43122 
Esophagus 
C15 
43287 
Esophagus 
C15 
43288 
Esophagus 
C15 
43286 
Small intestine 
C17 
44120 
Small intestine 
C17 
44121 
Small intestine 
C17 
44125 
Small intestine 
C17 
44202 
Small intestine 
C17 
96446 
Small intestine 
C17 
49203 
Small intestine 
C17 
49204 
Small intestine 
C17 
49205 
Colorectal 
C18, C19, C20 
44140 
Colorectal 
C18, C19, C20 
44143 
Colorectal 
C18, C19, C20 
44160 
Colorectal 
C18, C19, C20 
44145 
Colorectal 
C18, C19, C20 
44150 
Colorectal 
C18, C19, C20 
44141 
Colorectal 
C18, C19, C20 
44144 
Colorectal 
C18, C19, C20 
44146 
Colorectal 
C18, C19, C20 
44155 
Colorectal 
C18, C19, C20 
44157 
Colorectal 
C18, C19, C20 
44158 

22 
 
Colorectal 
C18, C19, C20 
44205 
Colorectal 
C18, C19, C20 
44204 
Colorectal 
C18, C19, C20 
44207 
Colorectal 
C18, C19, C20 
44210 
Colorectal 
C18, C19, C20 
44208 
Colorectal 
C18, C19, C20 
44212 
Colorectal 
C18, C19, C20 
44206 
Colorectal 
C18, C19, C20 
45110 
Colorectal 
C18, C19, C20 
45123 
Colorectal 
C18, C19, C20 
45111 
Colorectal 
C18, C19, C20 
45113 
Colorectal 
C18, C19, C20 
45395 
Colorectal 
C18, C19, C20 
45126 
Colorectal 
C18, C19, C20 
45119 
Colorectal 
C18, C19, C20 
45397 
Colorectal 
C18, C19, C20 
44147 
Colorectal 
C18, C19, C20 
44151 
Colorectal 
C18, C19, C20 
44156 
Colorectal 
C18, C19, C20 
45112 
Colorectal 
C18, C19, C20 
45114 
Colorectal 
C18, C19, C20 
44211 
Colorectal 
C18, C19, C20 
44640 
Colorectal 
C18, C19, C20 
44650 
Colorectal 
C18, C19, C20 
44661 
Colorectal 
C18, C19, C20 
96446 
Colorectal 
C18, C19, C20 
49203 
Colorectal 
C18, C19, C20 
49204 
Colorectal 
C18, C19, C20 
49205 
Biliary 
C22, C23, C24 
47120 
Biliary 
C22, C23, C24 
47122 
Biliary 
C22, C23, C24 
47125 
Biliary 
C22, C23, C24 
47130 
Biliary 
C22, C23, C24 
47600 
Biliary 
C22, C23, C24 
47605 
Biliary 
C22, C23, C24 
47610 
Biliary 
C22, C23, C24 
47612 
Biliary 
C22, C23, C24 
47620 
Biliary 
C22, C23, C24 
47711 
Biliary 
C22, C23, C24 
47712 
Biliary 
C22, C23, C24 
47562 
Biliary 
C22, C23, C24 
47563 
Biliary 
C22, C23, C24 
47564 
Biliary 
C22, C23, C24 
48150 
Biliary 
C22, C23, C24 
48152 
Biliary 
C22, C23, C24 
48153 
Biliary 
C22, C23, C24 
47579 
Pancreas 
C25 
48120 
Pancreas 
C25 
48140 
Pancreas 
C25 
48145 
Pancreas 
C25 
48146 
Pancreas 
C25 
48148 

23 
 
Pancreas 
C25 
48150 
Pancreas 
C25 
48152 
Pancreas 
C25 
48153 
Pancreas 
C25 
48154 
Pancreas 
C25 
48155 
Pancreas 
C25 
48160 
Pancreas 
C25 
48999 
GYN 
C53, C54, C55, 
C56 
49203 
GYN 
C53, C54, C55, 
C56 
49204 
GYN 
C53, C54, C55, 
C56 
49205 
GYN 
C53, C54, C55, 
C56 
58150 
GYN 
C53, C54, C55, 
C56 
58152 
GYN 
C53, C54, C55, 
C56 
58180 
GYN 
C53, C54, C55, 
C56 
58200 
GYN 
C53, C54, C55, 
C56 
58210 
GYN 
C53, C54, C55, 
C56 
58240 
GYN 
C53, C54, C55, 
C56 
58260 
GYN 
C53, C54, C55, 
C56 
58262 
GYN 
C53, C54, C55, 
C56 
58263 
GYN 
C53, C54, C55, 
C56 
58267 
GYN 
C53, C54, C55, 
C56 
58270 
GYN 
C53, C54, C55, 
C56 
58275 
GYN 
C53, C54, C55, 
C56 
58280 
GYN 
C53, C54, C55, 
C56 
58285 
GYN 
C53, C54, C55, 
C56 
58290 
GYN 
C53, C54, C55, 
C56 
58291 
GYN 
C53, C54, C55, 
C56 
58293 
GYN 
C53, C54, C55, 
C56 
58292 
GYN 
C53, C54, C55, 
C56 
58294 
GYN 
C53, C54, C55, 
C56 
58541 
GYN 
C53, C54, C55, 
C56 
58542 
GYN 
C53, C54, C55, 
C56 
58543 

24 
 
GYN 
C53, C54, C55, 
C56 
58544 
GYN 
C53, C54, C55, 
C56 
58548 
GYN 
C53, C54, C55, 
C56 
58550 
GYN 
C53, C54, C55, 
C56 
58552 
GYN 
C53, C54, C55, 
C56 
58553 
GYN 
C53, C54, C55, 
C56 
58554 
GYN 
C53, C54, C55, 
C56 
58570 
GYN 
C53, C54, C55, 
C56 
58571 
GYN 
C53, C54, C55, 
C56 
58572 
GYN 
C53, C54, C55, 
C56 
58573 
GYN 
C53, C54, C55, 
C56 
58575 
GYN 
C53, C54, C55, 
C56 
58661 
GYN 
C53, C54, C55, 
C56 
58662 
GYN 
C53, C54, C55, 
C56 
58700 
GYN 
C53, C54, C55, 
C56 
58720 
GYN 
C53, C54, C55, 
C56 
58940 
GYN 
C53, C54, C55, 
C56 
58943 
GYN 
C53, C54, C55, 
C56 
58951 
GYN 
C53, C54, C55, 
C56 
58953 
GYN 
C53, C54, C55, 
C56 
58954 
GYN 
C53, C54, C55, 
C56 
58956 
GYN 
C53, C54, C55, 
C56 
96446 
GYN 
C53, C54, C55, 
C56 
58950 
GYN 
C53, C54, C55, 
C56 
58952 
GYN 
C53, C54, C55, 
C56 
58957 
GYN 
C53, C54, C55, 
C56 
58958 
GYN 
C53, C54, C55, 
C56 
58960 
Kidney/Ureteral C64, C65, C66 
50220 
Kidney/Ureteral C64, C65, C66 
50230 
Kidney/Ureteral C64, C65, C66 
50240 
Kidney/Ureteral C64, C65, C66 
50234 

25 
 
Kidney/Ureteral C64, C65, C66 
50225 
Kidney/Ureteral C64, C65, C66 
50236 
Kidney/Ureteral C64, C65, C66 
50545 
Kidney/Ureteral C64, C65, C66 
50543 
Kidney/Ureteral C64, C65, C66 
50546 
Kidney/Ureteral C64, C65, C66 
50548 
Kidney/Ureteral C64, C65, C66 
50225 
Kidney/Ureteral C64, C65, C66 
50234 
Kidney/Ureteral C64, C65, C66 
50236 
Kidney/Ureteral C64, C65, C66 
50549 
Bladder  
C67 
51595 
Bladder  
C67 
51590 
Bladder  
C67 
51596 
Bladder  
C67 
51575 
Bladder  
C67 
51585 
Bladder  
C67 
51570 
Bladder  
C67 
51550 
Bladder  
C67 
51565 
Bladder  
C67 
51555 
Bladder  
C67 
51530 
Bladder  
C67 
51580 
Bladder  
C67 
51597 
Prostate 
C61 
55810 
Prostate 
C61 
55840 
Prostate 
C61 
55845 
Prostate 
C61 
55821 
Prostate 
C61 
55831 
Prostate 
C61 
55815 
Prostate 
C61 
55801 
Prostate 
C61 
55842 
Prostate 
C61 
55866 
Prostate 
C61 
55812 
Prostate 
C61 
55815 
Prostate 
C61 
55865 
Testes  
C62 
54530 
Testes  
C62 
54535 
Testes  
C62 
38780 
 
 
 
 
 
 
 
 
 

26 
 
APPENDIX 2: RedCAP Survey 
 
Many patients have trouble understanding the medical information they receive at the hospital or doctor’s office.  
1. How confident are you filling out medical forms by yourself? 
Extremely, quite a bit, somewhat, a little bit, not at all 
2. How often do you have someone help you read hospital materials? 
All of the time, most of the time, somewhat, a little of the time, none of the time 
3. How often do you have problems learning about your medical condition because of difficulty understanding 
written information? 
All of the time, most of the time, somewhat, a little of the time, none of the time 
4. Were you sent home with a prescription or over-the-counter medicine to prevent blood clots?  
a. Yes b. No (end survey) 
5. Did you take all of the prescribed doses?  
a. Yes (skip to q8) b. No (q6) 
6. How many blood thinner doses did you miss in 30 days after surgery?  
a. Less than 3 b. 3 to 6 doses c. 7 to 10 doses d. More than 10 doses 
7. Check all reasons for missing doses:  
a. I forgot b. Ran out of medicine; too expensive to refill c. Did not have enough help available to give the 
medicine d. Did not like taking the medicine e. Had a complication (like bleeding) and was instructed to stop 
taking the medicine f. Was readmitted to the hospital g. Never filled the prescription (free text – why) h. Other 
(free text) 
8. Did you develop a blood clot during the post-operative period? a. Yes b. No 
9. Did you have any major bleeding during the post-operative period? a. Yes b. No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX 3: IRB Approval 
 
 Institutional Review Board for Human Research (IRB) 
Office of Research Integrity (ORI) 
Medical University of South Carolina 
 
South Park Plaza 
1 South Park Circle, Bldg. 1, Suite 401 
Charleston, SC. 29407 
Federal Wide Assurance # 1888 
 
APPROVAL: 
 
 
 
 
 
 
 
 
This is to certify that the research proposal Pro00130488 entitled: 
A stepped-wedge randomized trial using multi-faceted surgeon-focused education to evaluate the impact of a decision support 
tool and VTE-related pre-discharge education to increase adherence to guideline-concordant extended venous 
thromboembolism prophylaxis after major abdominopelvic cancer surgery. 
 
 
 
submitted by:  Thomas Curran 
 
Department: GI / LAPAROSCOPIC SURGERY - MUSC  
 
Sponsor: NCI 
 
 
 
for consideration has been reviewed by IRB-II - Medical University of South Carolina and approved.  In accordance with 45 CFR 
46.104(d), the referenced study is exempt from Human Research Subject Regulations.  The IRB has approved the request for a Waiver 
of HIPAA Authorization, after determining that the waiver of authorization satisfies the criteria set forth in the HIPAA Privacy Rule at 
45 CFR 164.512(i)(2).  The waiver of authorization was reviewed and approved by the IRB. The IRB has determined that the 
protected health information necessary to be used/accessed is as outlined in the protocol and/or IRB application. 
 
No further action or IRB oversight is required, as long as the project remains the same.  However, you must inform this office of any 
changes in procedures involving human subjects.  Changes to the current research protocol could result in a reclassification of the 
study and further review by the IRB. 
 
 
 
 
Approval Date: 7/24/2023 
Approval Expiration: 7/24/2028 
 
 
Type: Exempt 
Category:  2 
 
Administrator, - Medical University of South Carolina 
Summer Young, MPH, CIP 
 
Electronic Signature: This document has been electronically signed by the IRB Administrator through 
the HSSC eIRB Submission System authorizing IRB approval for this study as described in this letter. 
 
Important Note: Approval by the Institutional Review Board does not, in and of itself, constitute approval for the implementation of 
this research. Other MUSC clearances and approvals or other external agency or collaborating institutional approvals may be 
required before study activities are initiated. Research undertaken in conjunction with outside entities, such as drug or device 
companies, are typically contractual in nature and require an agreement between the University and the entity. 
 

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TO PRINCIPAL INVESTIGATOR 
 
 
The IRB approval for your study has been released. Please see below for helpful reminders. 
 
 
IRB POLICIES AND PROCEDURES 
The link below will connect you to all IRB all IRB policies and procedures: 
http://academicdepartments.musc.edu/research/ori/irb/policies.html 
Here you will find important policy information regarding items such as: amendments, 
continuing reviews, protocol deviations, unanticipated problems and adverse events, etc. 
 
INFORMED CONSENT AND HIPAA 
Use only stamped IRB approved consent(s) and HIPAA. As the Principal Investigator, you are 
also required to make sure each person obtaining consent is approved and listed on your 
protocol and uses the most currently approved version of the consent(s)/HIPAA.   
 
COMPLIANCE AUDITS FOR HUMAN RESEARCH STUDIES 
The MUSC Compliance Office will randomly select human research studies for routine audit. 
Audits “for cause” will be conducted as necessary.  The checklist used by the Compliance 
Auditor is located on the compliance website at:  
https://horseshoe.musc.edu/everyone/compliance/univ-compliance/research/human-
subject-audits/checklists 
 
SUCCESS CENTER 
The SUCCESS Center provides a variety of resources at no charge for PIs and study teams at 
any point in the research process including individualized training and consultation for 
regulatory submissions and documentation.  Contact SUCCESS at: 
843-792-8300 or success@musc.edu 
https://research.musc.edu/resources/sctr/about/success