The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial
Phase: NA
Conditions: Resident Knowledge and Attitudes Regarding Cross-cultural Care, Interpersonal and Communication Skills in Patient-clinician Encounters, Patient-reported Satisfaction With Resident Physicians Involved in Their Care, Patients' Clinical Health Outcomes After Surgery
Sponsor: Brigham and Women's Hospital

Cover Page for ClinicalTrials.gov 
 
 
 
 
 
 
 
 
Oﬃcial Study Title:  
Evalua'on of a Cultural Dexterity Training Program for Surgeons: The PACTS Trial 
 
NCT Number:  
NCT03576495 
 
Document: 
Study Protocol 
 
Document Date:  
September 18, 2020 

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
1 
 
Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR 
Adil H. Haider, MD, MPH 
 
PROTOCOL TITLE 
The Provider Awareness and Cultural Dexterity Toolkit for Surgeons (PACTS) 
Trial 
 
FUNDING 
 
1R01MD011685-01A1 
 
VERSION DATE 
 
September 18, 2020 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
 
Racial disparities in surgical care have been well-documented. In 
response to the IOM’s 2003 recommendations on taking a multi-pronged 
approach to alleviating disparities that includes cultural competency training, 
we have proposed cultural dexterity, rather than cultural competency, as a 
modality for imparting such training to surgical residents. The purpose of 
this protocol is to test the impact of this new curriculum, called Provider 
Awareness Cultural Dexterity Toolkit for Surgeons (PACTS), on surgical 
residents’ cross-cultural knowledge, attitudes, and skills surrounding the 
care of diverse patients, as well as patient-reported and clinical outcomes for 
patients treated by surgical residents undergoing this training.    
 
1. Aim 1: Evaluate the impact of PACTS on surgical residents’ knowledge 
and attitudes about caring for culturally diverse patients using a pre-
and post-assessment.   
Hypothesis 1: Residents receiving PACTS will show greater 
improvement in knowledge and attitudes compared to those who did 
not.    
  
2. Aim 2:  Determine the impact of PACTS on surgical residents’ cross-
cultural skills as demonstrated in a simulated clinical setting, using an 
Objective Structured Clinical Examination (OSCE) and by self-report.  
Each OSCE station will assess one of the four core topics covered by 
the PACTS training.   

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
2 
 
Hypothesis 2: Residents receiving PACTS will demonstrate greater 
improvements in cross-cultural skills.  
 
3. Aim 3:  Assess effectiveness of PACTS on improving clinical outcomes 
and patient-reported outcomes.  We will survey patients cared for by 
residents enrolled in the study on: (1) satisfaction with pain 
management, (2) physician communication, (3) trust and (4) 
comprehension of informed consent.  In addition, we will use data 
from the National Surgical Quality Improvement Program (NSQIP) to 
measure surgical complications, length of stay, 30-day mortality, 
morbidity, and readmissions for all patients.  
Hypothesis 3: Patients cared for by residents who have completed 
PACTS will exhibit better clinical and patient-reported outcomes. 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
Minority patients experience worse overall health outcomes, and these 
disparities are especially apparent in the costly, high-risk specialty of 
surgical care. To address this, the National Institute on Minority Health and 
Health Disparities (NIMHD) collaborated with the American College of 
Surgeons (ACS) to establish research priorities for surgical disparities. One 
of the top priorities was to evaluate the effect of improvement in culturally 
dexterous care on surgical outcomes for patients from disparity populations. 
Adverse outcomes for minority patients, including patients with limited 
English proficiency, have been demonstrated because of poor patient-
provider communication. We propose that such deficiencies in 
communication contribute to treatment errors, inadequate pain 
management, less patient-centered care, decreased adherence to treatment 
plans, and worse overall clinical outcomes. Additionally, studies have 
illustrated the preponderance of pro-White implicit biases, which are 
unconscious, automated preferences that individuals may not even be aware 
of, among surgeons.  
 
Formal training in cultural competency is generally integrated in the 
undergraduate medical education curricula, but this training rarely continues 
into specialty-specific post-graduate training. Few surgical programs have 
attempted to incorporate cross-cultural communication skills into their 
educational paradigms, and the approaches to doing so have been 
inconsistent. Our examination revealed that these programs’ success was 
limited by a lack of specificity to the surgical context, as well as diminished 
applicability of the concepts to real-life practice. Therefore, we adapted a 
novel approach to cross-cultural communication for surgical trainees, known 
as cultural dexterity. Cultural dexterity refers to a set of skills and cognitive 
practices used to maximize communication across multiple dimensions of 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
3 
 
cultural diversity, and deviates from the concept of cultural competency in 
that it does not demand that learners associate certain practices and 
behaviors with individuals based on generalizations. Our cultural dexterity 
curriculum, known as PACTS (Provider Awareness Cultural Dexterity Toolkit 
for Surgeons) focuses on developing cognitive skills to adapt to individual 
patients’ needs to ensure personal, patient-centered surgical care. Experts in 
education and cross-cultural communication were convened, along with 
patient advocates and representatives, to inform the conceptual 
development of our curriculum. The curriculum is comprised of four 
educational modules on establishing trust in the physician-patient 
relationship, communicating effectively with patients with limited English 
proficiency, discussing informed consent, and issues surrounding pain 
management. Each module consists of an independent learning activity, an 
interactive role-play, and a post-lesson assessment. Cumulative evaluation 
of learners’ knowledge, attitudes, and skills will take place after all four 
modules have been completed. Assessment tools are outcome measures are 
described in further detail below.  
 
In anticipation of this protocol, we have pilot-tested the curriculum at 
three affiliated institutions with general surgery residents at varying levels of 
training. Focus group data was collected to garner feedback on the 
effectiveness and feasibility of the curriculum. The purpose of the current 
protocol is to implement the curriculum across eight institutions and 
measure resident-level competency outcomes, as well as patient-
reported and clinical outcomes, following this training.   
 
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
 
We will conduct a cross-over, cluster-randomized trial at 8 academic 
medical centers (AMCs) to capture the effect of PACTS on: 1) resident 
knowledge and attitudes regarding  cross-cultural  health  care  [Specific  
Aim  (SA)1],  2)  interpersonal  and  communication  skills  in  simulated  
patient-clinician  encounters  [SA2],  and  3)  patient-reported  satisfaction  
with  resident  physicians  involved  in  their  care,  and  clinical  outcomes  
[SA3].  Sites will be assigned to an early intervention/retention assessment 
group or a control group with delayed intervention for examination of the 
effectiveness of the intervention as well as learner retention.  After cluster-
randomization, we will assess the residents’ knowledge, attitudes, and skills 
prior to and after the PACTS curriculum at half the sites (Early 
Intervention/Retention Group). We plan to conduct follow-up testing after 
one year to evaluate learner retention.  

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
4 
 
 
At the other sites (Delayed Intervention Group), we will conduct 
baseline testing prior to the standard residency curriculum, and administer 
the PACTS curriculum the following year. This study design will enable us to 
examine both between- and within-group differences based on curriculum 
exposure in intervention year 1 as well as within-group differences for the 
Delayed Intervention Group at the end of year 2. Further, we will also be 
able to test post-exposure effect retention in the Early Intervention Group at 
the end of year 2.   
 
We are partnering with eight general surgery residency programs and 
their affiliated hospitals to conduct the PACTS Trial. Programs have been 
matched to achieve balanced cohorts in terms of program size and diversity 
of patient population. Based on case mix, we anticipate approximately 40% 
of the patient population in this study will be of minority descent. The eight 
programs that will be participating in this study are: 1) Johns Hopkins 
University, 2) Brigham and Women’s Hospital, 3) Brown University, 4) 
Eastern Virginia Medical School, 5) Massachusetts General Hospital, 6) Beth 
Israel Deaconess Medical Center, 7) Howard University, and  8) Washington 
University in St. Louis.  
 
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
 
Surgery Focus Group 
 
 
In anticipation of the implementation of the cross-over, cluster-
randomized trial at the 8 academic medical centers, we hope to gather 
feedback from surgical residents, medical students, and surgical faculty in 
training programs outside of these sites to assist in the development of the 
cultural dexterity curriculum. We believe that surgical conferences would be 
the best opportunity to gain insight regarding the current curriculum content 
as well as curriculum implementation. Contributions from surgical residents, 
medical students, and surgical faculty will be important to supplement the 
previous input from surgical faculty and program directors.  
 
We plan to recruit participants from the surgical specialty excluding 
those from our 8 academic medical centers. We will disseminate one of four 
modules of the curriculum in advance for review. Participants will then be 
scheduled for a 1 hour-long focus group based on their availability, with a 
total of four focus groups. Focus groups will be facilitated by two study staff 
in a semi-structured focus group model. We believe this input will be integral 
in ensuring that our cultural dexterity curriculum can eventually be 
implemented in all surgical training programs across the country.  

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
5 
 
 
Patients Focus Group 
 
Patient advisors will be recruited through Brigham and Women’s 
Hospital Center for Patients and Families as well as other Centers for 
Patients from participating sites. This will consist of 1 hour-long focus groups 
to collect feedback from former and existing patients to ensure that the 
curriculum is appropriate in addressing the needs of culturally diverse 
patient groups. Additionally, we will be collecting feedback regarding the 
patient survey that will be used by patients treated by residents who have 
undergone the cultural dexterity training to evaluate their satisfaction and 
clinical quality. The survey will be used to evaluate patient satisfaction with 
pain management, communication, trust-building, and comprehension of the 
informed consent. 
 
Residents 
 
The curriculum incorporates contemporary learning practices such as 
the “flipped classroom” model, team-based learning, and independent study 
that have been studied in undergraduate medical education but have not yet 
been examined in the graduate medical education setting. It consists of a 
30-minute e-learning module that is accessed via secure login on personal 
computers, smart phones, or tablets. The module is built in the Werkz 
platform and hosted on participating institutions’ servers. Following 
completion of e-learning modules, learners will attend interactive sessions in 
which residents will apply concepts from the e-learning to role-play scenarios 
constructed in a team-based learning format. Residents will be given 
detailed, scripted prompts for the role-play sessions, for which they will be 
divided into small groups. Structured feedback will be solicited from peers 
and facilitators. The group will reconvene for discussion and reflection at the 
end of the session. During the delivery of the curriculum, residents will also 
be provided opportunities for spaced-learning in the form of multiple choice 
questions based on the curriculum emailed through the REDCap system.  
 
To evaluate the impact of PACTS on surgical residents’ knowledge and 
attitudes about caring for diverse patients, we will use a pre- and post-test 
in the form of validated instruments that assess knowledge, attitudes, and 
self-reported skills on a Likert-type scale. This pre- and post-test will be 
piloted among a group of surgical residents (N=40) to assess the survey 
length and clarity of questions. Residents will be recruited using a 
convenience sampling method from those who participated in the surgery 
focus groups at ASC 2019. Exclusion criteria from this pilot will be residents 
at one of the trial AMCs.  
 
Resident skills will also be objectively assessed through an Objective 
Structured Clinical Examination (OSCE) that will be created by the study 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
6 
 
staff and administered immediately before the intervention and within 1-6 
months after the intervention has been completed. The OSCE uses 5-point 
Likert scale questions to evaluate resident performance across multiple 
domains. A Standardized Patient evaluator and a third-party trained 
impartial observer will evaluate the residents on these domains, and the 
resulting numerical scores will be averaged. It will serve both a summative 
and educational purpose in this context. Due to the COVID-19 pandemic, in 
order to adhere to social distancing protocols, the OSCE may also be 
delivered virtually using a secured web-based video-conference software. 
 
We have also developed a novel survey instrument to assess resident 
knowledge, attitudes, and self-reported skills. This instrument is adapted 
from pre-existing, validated instruments such as the Cultural Competence 
Health Practitioner Assessment (CCHPA), developed by the National Center 
for Cultural Competence, and modified to be relevant to surgical training and 
practice. Residents will be required to take a knowledge survey before and 
after receiving the PACTS curriculum or standard training. Attitudes 
regarding the importance of facing cross-cultural health care situations will 
be assessed across multiple domains using a novel survey instrument that is 
based on a survey that was used in a similar curriculum aimed at medical 
students, as well as the Values and Belief Systems domain.  
 
Patients 
 
To evaluate patients’ satisfaction and clinical quality related to PACTS 
training, we will employ research assistants to administer surveys to patients 
treated by residents to determine satisfaction with pain management, 
communication, trust-building, and comprehension of the informed consent 
discussion two months before and after the intervention is implemented. 
Patient satisfaction will be assessed using elements of the validated Pain 
Treatment Satisfaction Scale (PTSS). Patients will complete this survey 
privately after a brief explanation and informed consent from the research 
assistant. Patients will be asked to provide their self-reported race/ethnicity. 
Finally, clinical surgical outcomes obtained from the NSQIP database and/or 
electronic health record will be assessed for each patient participant before 
and after the PACTS curriculum is implemented to measure individual 
outcomes such as length of stay, postoperative complications, unplanned 
reoperations, and 30-day morbidity/mortality. The survey will be translated 
into 5 additional languages (Spanish, Portuguese, Haitian Creole, Simplified 
Chinese, and Traditional Chinese) in order to ensure a representative patient 
sample from diverse groups of patients. This survey will be piloted (N=10) 
from Partners sites using a convenience sampling method to assess the 
length of time required for survey completion and clarity of questions. 
 
Resident Curriculum Impact Focus Groups 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
7 
 
Due to the COVID-19 pandemic and increased focus on structural 
racism and equity in medicine, we believe that residents undergoing our 
curriculum may have had experiences that could provide further insight into 
providing equitable care. We believe that surgical residents who are 
receiving the curriculum would offer the best opportunity to gain insight 
regarding how the current curriculum content has impacted the care they 
provide their patients. 
 
Focus group participants will be recruited from current PACTS 
participants. Two focus groups will be conducted at each PACTS site, with 8-
10 participants in each focus group. Focus groups will be facilitated by study 
staff in a semi-structured focus group model. 
 
PACTS Program/ Curriculum Evaluation 
 
In order to assess the components of the curriculum by the residents 
who have participated in the curriculum we plan to provide the residents an 
evaluation form via REDCap. The program evaluation will provide feedback 
based on a 5-point Likert scale questions to rate components of the 
curriculum. The residents will also have open-ended questions to provide 
any additional comments or suggestions on the curriculum.  
 
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
 
 
Currently, there is no standard for cultural dexterity training among 
surgical residents. The ACGME identifies core competencies, two of which 
address cross-cultural communication and patient-centered care, but these 
do not correspond to standardized educational curricula across residency 
programs.  
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
 
 
To minimize risk, such as the risk of residency program directors 
learning of individual residents’ scores or of residents learning of patients’ 
individual evaluations of their communication skills, all participants will be 
assigned a unique, de-identified study ID number. Only the study ID will be 
used on surveys and outcomes assessments.   
 
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
8 
 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
 
The focus groups will be recorded through digital voice recorders or 
conducted via secured virtual web-based video conference software. After 
the focus groups, the recordings will be stored securely within the Center for 
Surgery and Public Health and transcribed by study staff members. All 
patient and resident data will be de-identified.  
 
All patient information will be completely de-identified and the 
research assistant administering the survey will not be permitted to share 
information about patients’ participation in the trial with the resident 
subjects providing their care, to protect patients against potential differential 
treatment based on their participation or lack thereof in the study.  
 
Similarly, information about resident participation will not be shared 
with the residency program directors, and residents’ performances on 
assessment measures will be removed of any potential identifying 
information such that these performance evaluations will not be factored into 
the residents’ overall performance in their residency training program. 
Furthermore, though the curriculum will be delivered as part of all general 
surgery residents’ didactic training, the research team will explain that 
participation in the study is entirely voluntary and declining to participate 
will have no bearing on residents’ status within their program. To protect 
against risk of program directors learning of individual residents’ scores or 
residents learning of patients’ individual responses, all participants will be 
assigned a unique study ID. Only the study ID will be used on surveys and 
outcomes measures. 
 
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
 
The study poses low risk to residents and patients. Participants in the 
focus groups may feel nervous sharing their opinions. We will ensure that all 
participants know that they do not need to share anything in the focus 
groups that they are uncomfortable with. For surgical residents, they may 
experience nervousness or concern knowing that their clinical interactions 
are being monitored and assessed; however, we will assure them that their 
individual performance will remain unknown to anyone at their site and 
therefore will not impact their performance in residency. For patients, they 
may experience minor psychological distress while participating in the study 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
9 
 
in the setting of acute illness. However, the research assistants will be 
instructed to screen patients for physical and mental fitness prior to 
beginning the survey. Research assistants will also stop the survey if the 
patient demonstrates or verbalizes any distress. Patients may also be 
concerned about their negative responses impacting their care. To address 
this, we will try to focus on patients who are approaching discharge and 
assure all patients that their individual responses will not be shared with 
their care team. 
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
 
 
The research will benefit residents by giving them tools to better 
navigate patient care. It could also benefit patients by better equipping their 
physicians to investigate health beliefs, work with medical interpreters, and 
facilitate informed patient-centered care. The research will also benefit 
future surgical residents who will undergo this type of training, as well as 
future patients who will be cared for by these residents. The anticipated 
benefits outweigh the low potential risks of this study.  
 
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
 
Four populations of human subjects will be involved in this study: 1) 
surgical residents (clinical post-graduate years 1-5) from the 8 academic 
medical centers, 2) patients treated by those residents, 3) surgical residents 
outside of the 8 academic medical centers who will participate in focus 
groups and survey pilot, and 4) previous or current nonsurgical patients 
prior to the implementation of the PACTS curriculum who will participate in 
the patient focus group and patient survey pilots.  
TARGETED/PLANNED ENROLLMENT: Resident subjects (n=400) 
Ethnic Category 
Females Males 
Total 
Hispanic or Latino 
9 
19 
28 
Not Hispanic or Latino 
123 
249 
372 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
10 
 
 
 
Surgical residents: All residents at each study site will receive the 
educational intervention. Enrollment and consent will be discussed by the 
research assistant, and program directors will not have access to resident 
enrollment information. We anticipate enrolling 400 surgical residents at the 
beginning of the study. We expect that the population will have the following 
racial composition based on average racial composition of surgical 
residency programs as reported by the Accreditation Council of Graduate 
Medical Education (ACGME): 55% White, 6% Black, 7% Hispanic, 19% 
Asian/Pacific Islander, <1% Native American, and 12% other.1 They will 
range in age from 25 to 36. Based on the ACGME reports, approximately 
33% of these residents will be female, and resident subjects will not be 
excluded from the study based on their gender. 
 
Patients: We will recruit 3,105 patients overall, and approximately 345 
patients per site. To be included in the study, patient subjects must be 
admitted to a surgical service under the care of a resident enrolled in the 
study, able to recognize a photo of the resident as a main care provider, 
fluent in English, Spanish, Portuguese, Haitian Creole, Simplified Chinese, or 
Traditional Chinese, and older than 18 years of age. We will oversample 
Ethnic Category: Total of All Subjects 132 
268 
400 
Racial Categories 
 
 
American Indian/Alaska Native 
1 
3 
4 
Asian, Native Hawaiian, or Other 
Pacific Islander 
25 
51 
76 
Black or African American 
8 
16 
20 
Other 
16 
32 
48 
White 
73 
147 
220 
Racial Categories: Total of All 
Subjects 
123 
249 
372 
TARGETED/PLANNED ENROLLMENT: Patient subjects (n=2400) 
Ethnic Category 
Females Males 
Total 
Hispanic or Latino 
300 
300 
600 
Not Hispanic or Latino 
900 
900 
1800 
Ethnic Category: Total of All Subjects 1200 
1200 
2400 
Racial Categories 
 
 
American Indian/Alaska Native 
24 
24 
48 
Asian, Native Hawaiian or Other 
Pacific Islander 
120 
120 
240 
Black or African American 
300 
300 
600 
White 
456 
456 
912 
Racial Categories: Total of All 
Subjects 
900 
900 
1800 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
11 
 
minority patients to achieve at least 40% Black and Hispanic patients. We 
will identify patients using the patient list from each resident enrolled in the 
study during the 2-month pre- and post- data collection windows. We are 
targeting underrepresented minority patients because they are at most risk 
for poor communication with providers and such interactions have greater 
potential for improvements. 
 
          
White patients will not be excluded from the study; the emphasis is on 
racially discordant physician/patient dyads, and white patients will be 
included for the assessment of non-white resident subjects. As we expect 
that the gender demographics of the patient subject group will somewhat 
reflect the gender demographics of the general population, we anticipate 
50% of the patient subjects to be female. There will be no exclusion of 
subjects based on gender or ethnicity. 
 
Residents and patients will be recruited from 8 sites: Brigham and Women’s 
Hospital, Beth Israel Deaconess Medical Center, Massachusetts General 
Hospital, Brown University, Howard University, Johns Hopkins University, 
Eastern Virginia Medical School, and Washington University in St. Louis. 
Each of these sites is in or near a major metropolitan area, with racially and 
ethnically diverse patient populations. Research assistants at each site will 
have access to each resident subject’s panel of inpatients, which will also 
allow the research assistant to identify the patients’ racial information and 
proximity to discharge from the hospital. For the Residents Curriculum 
Impact Focus Groups, the residents will be recruited from the residents 
already consented and enrolled in the trial. The PACTS Program/ Curriculum 
Evaluation will be provided to all residents who have undergone the 
curriculum. 
 
 
Focus group participants outside of the 8 AMCs 
 
Participants will be recruited for focus group and survey recruitment outside 
of the 8 AMCs participating in the trial. Individuals will be recruited from a 
random sample of academic medical centers without any emphasis or 
exclusion criteria on any specific gender, race, or ethnicity. As such, this 
should allow for a fairly representative sample. The goal will be to recruit 40 
total participants for the focus groups at each academic conference.  
 
Participants will also be asked to pilot the resident survey using a 
convenience sampling method based on focus group participation. 
 
Previous or current patients prior to the implementation of the 
PACTS curriculum 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
12 
 
These patient advisors for the focus groups will be recruited from a random 
sample through Brigham and Women’s Hospital Center for Patients and 
Families and other Centers for Patients without any emphasis or exclusion 
criteria on any specific gender, race, or ethnicity. As such, this should allow 
for a fairly representative sample. The goal is to recruit 10 participants per 
focus group.  
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
 
 
To be included in the study, patient subjects must be fluent in English 
or Spanish, and older than 18 years of age. We will oversample minority 
patients to achieve at least 40% Black and Hispanic patients. The language 
requirement is needed to ensure that the instruments and survey tools are 
accurately conveyed. 
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          https://partnershealthcare-public.sharepoint.com/ClinicalResearch/Non-
English_Speaking_Subjects.1.10.pdf
 
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
 
Surgery Focus Group Recruitment 
 
 
Participants will be recruited using a convenience sampling method. 
Trial investigators will reach out to residency program directors at 
organizations not participating in the trial to ask that an information sheet 
be shared with medical students, surgical residents, or surgical faculty. 
Individuals will be able to register to participate in a focus group online and 
will be provided with provided additional information about the focus group 
and scheduling information at that time. In addition, twitter may be used to 
recruit participants at a specific conference or event by using the conference 
hashtag to reach a broad audience of attendees and providing the online 
registration information. 
 
Resident Survey Pilot Recruitment 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
13 
 
 
Participants of the resident focus group will be asked to pilot the 
resident pre- post-test. In addition, research fellows at the Center for 
Surgery and Public Health who are not part of participating residency 
programs may also be asked to pilot the survey.  
 
Patient Focus Group Recruitment 
 
Participants will be patient advisors who were selected by their 
providers to participate on their respective Patient Family Advisory Council. 
These patient advisors are current or previous patients who have 
demonstrated an interest in trial. The patient advisors will be recruited 
through Brigham and Women’s Hospital Center for Patients and Families and 
other Centers for Patients at participating sites.  
 
Patient Survey Pilot Recruitment 
 
Patient advocates from the patient focus group will be asked to pilot 
the patient survey. Additional patients may be recruited from a convenience 
sampling from the Patient Family Advisory Council. These patient advisors 
are current or previous patients who have demonstrated an interest in trial. 
The patient advisors will be recruited through Brigham and Women’s 
Hospital Center for Patients and Families and other Centers for Patients at 
participating Partners sites. 
 
Resident Recruitment 
 
All general surgery residents will receive the educational curriculum; 
each site’s Program Director (PD) has agreed to schedule PACTS training 
during compulsory didactic sessions, when residents are free from clinical 
duties. However, participation in study assessments (OSCEs and knowledge-
testing) is voluntary and will not impact residents’ performance in their 
program. Final analyses will include enrolled residents regardless of their 
attendance in live modules, reflecting an “intention-to-treat” analysis 
approach.  This will more accurately demonstrate the “real world” benefit of 
PACTS, as not all residents may be able or willing to attend all live sessions.  
Based on the size of the residency programs, which ranges between 46 and 
72 residents, and the away rotation schedules, we expect to enroll 200 
residents per arm for analysis (an average of 50 residents per site).     
 
Patient Recruitment 
 
At the onset of clinical rotations, the Program Manager will contact surgical 
residency Program Coordinators to attain general surgery resident rotation 
schedules. The Program Manager will identify the dates and times of resident 
study participants’ rotations. On these dates and times, Research Assistants 
working under the supervision of the Program Manager will verify that the 
resident is on rotation and use the EHR at the surgical service site to 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
14 
 
randomly select at least two eligible patients from the EHR. First, the RA will 
approach the patients’ nurse and ask whether the nurse might have a 
concern regarding the selected patients’ cognitive status. If the nurse has no 
concerns, the nurse will be asked to introduce study staff to the patient. 
Staff will provide an information sheet, describe the study, and ask them to 
identify a resident participating in the PACTS trial who they recall interacting 
with. The RA will explain the study and provide the patient with a copy of the 
Patient Information Sheet and survey, which will be administered via tablet 
or laptop computer to access the survey in the Partners-hosted REDCap 
database. Completion of the English or Spanish language survey will indicate 
consent to participate in the study and the patient will be enrolled. 
 
If the nurse has a concern, the nurse will be asked to introduce the RA will 
approach the patient, and the RA will assess interest in the study, and 
administer a validated cognitive impairment screening tool (e.g. the Brief 
Confusion Assessment Method or the 4AT). If the patient is not interested in 
participating in the study or has a positive screen for cognitive impairment, 
the RA will not enroll the patient. If the patient does not screen positive, 
they will then be showed the picture of the resident for confirmation as 
above. 
 
Please see the Patient Recruitment Flowchart in the attachments for an 
overview. 
 
Patient inclusion criteria are: (1) admitted to surgical service under care of a 
participating resident; (2) able to recognize resident as a main care provider 
from a photo; (3) fluent in English, Spanish, Portuguese, Haitian Creole, 
Simplified Chinese, or Traditional Chinese. Patient exclusion criteria are: (1) 
admitted to Intensive Care; (2) mentally impaired and/or not oriented to 
person/time/ place. 
 
In total, we will enroll 3105 patients across all sites (Table 7). If the 
patient is ineligible or unwilling to participate, another patient will be 
randomly selected from the e-mail list of patients.  Patient sampling will be 
such that 40% of included patients will be racial or ethnic minorities. The 
overall proportion of racial/ethnic minority patients at each institution ranges 
from 24%-47% (excluding Howard University which has 90%), suggesting 
sufficient diversity across sites.  Patient populations in surgical service will 
likely be even more diverse, as this includes both emergency surgery and 
trauma patients. 
 
 
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
15 
 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
Not applicable.  
 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Recruitment_Of_Research_Subjects.pdf
 
          Guidelines for Advertisements for Recruiting Subjects
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Guidelines_For_Advertisements.1.11.pdf
 
          Remuneration for Research Subjects
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Remuneration_for_Research_Subjects.pdf
 
 
CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
 
Focus Groups 
 
Participants will be provided a fact sheet that contains information 
regarding the focus group that they will be participating in. Consent will be 
indicated either through completion of an online registration form or through 
participation in the focus group.  
 
Survey Pilots 
 
Participants will be provided with a fact sheet that contains information 
regarding the survey pilot. Consent will be indicated through voluntary 
completion of the survey. 
 
Residents 
Each program director will initiate recruitment for their site and 
provide email contacts, but a research assistant will enroll and consent 
residents. Following the didactic curriculum and prior to the first testing 
sessions, residents will review an informational sheet that they may keep for 
reference. Completing the resident surveys will indicate consent to 
participate in the study. Prospective subjects will be reminded that their 
decision to enroll in the study will remain confidential, as will their 
performance evaluations if they choose to participate. De-identified informed 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
16 
 
consent documents will be maintained by the research assistant in a locked 
folder on-site or on a protected and secure database. 
 
Patients 
 
Patients who meet our inclusion criteria will be explained the study 
aims, protocol, and risks and benefits of participation by a research 
assistant. They will have a chance to review the consent form and receive a 
copy if they so choose. Information/Consent forms have been developed in 
all languages in which the survey is available (Spanish, Portuguese, Haitian 
Creole, Simplified Chinese, and Traditional Chinese) by certified translators. 
If needed, Research Assistants will utilize translators to communicate with 
patients speaking languages other than English. Completing the patient 
surveys will indicate consent to participate in the study. De-identified 
informed consent documents will be maintained by the research assistant in 
a locked folder on-site or on a protected and secure database. 
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
      https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb 
 
For guidance, refer to the following Partners policy: 
     Informed Consent of Research Subjects:
     https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Informed_Consent_of_Research_Subjects.pdf
 
 
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
 
All patient and resident data will be de-identified for storage. Data will 
be stored on a password-protected server. Only the PI and the researchers 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
17 
 
will have access to the server. The PI will be responsible for reviewing the 
data and for the confidentiality of the data. 
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
 
Research assistants will be advised to notify the patient’s attending 
physician if the patient divulges suicidal or homicidal ideation during the 
survey. Otherwise, there are no anticipated opportunities for discovery of 
incidental findings. If any subject feels uncomfortable and wishes not to 
participate, they will be able to speak with the PI at any time and/or 
withdraw from the study with no consequences for their participation in their 
residency program nor their ability to receive care at our participation 
institutions. 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
The focus groups will be facilitated by two study staff. The digital 
recorders used to record the focus groups will be securely stored in the 
Center for Surgery and Public Health, and transcriptions will be stored in a 
secure, password-protected database. The virtual focus group data will be 
recorded and saved digitally on a Mass General Brigham encrypted computer 
and stored in a secure, password-protected database. 
 
Data collection and monitoring will be coordinated across the 8 AMCs 
through a multimedia approach. Video teleconferencing will be utilized and a 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
18 
 
website will be created to ensure smooth coordination and scheduling of the 
PACTS curriculum across the sites. Each site investigator will be responsible 
for managing research assistants and data collection at their institution. 
Survey data (such as patient surveys, resident pre- and post-tests, and 
OSCCE scoring) will be collected via a Partners-hosted REDCap survey. Data 
will be stored in a secure location at each AMC and will be accessed by the 
research assistant, who will be trained to enter the de-identified data into 
the secure, password-protected database. The Project Director will have 
access to the unique IDs assigned to the subjects, but the individual site co-
investigators will not. There are no anticipated limitations to confidentiality. 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
            https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/DSMP_in_Human_Subjects_Research.pdf  
          
          Reporting Unanticipated Problems (including Adverse Events)
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Reporting_Unanticipated_Problems_including_A
dverse_Events.pdf
 
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
 
 
The focus groups will be recorded through digital voice recorders or 
virtual via secured web-based video conference software. After the focus 
groups, the recorders will be stored securely within the Center for Surgery 
and Public Health for transcription. All patient and resident data will be de-
identified for storage. Data will be stored on a password-protected server. 
Only the PI and the researchers will have access to the server. The PI will be 
responsible for reviewing the data and for the confidentiality of the data. 
 
Resident subjects’ performance on surveys and simulated clinical 
encounters will be kept confidential through de-identification of the data. All 
residents in the program will receive the training and will be required to 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
19 
 
participate in the interactive learning sessions as a quality improvement 
initiative; residents’ divulging of information during these sessions will be 
kept private in the confines of the didactic sessions that are restricted to 
surgical trainees. 
 
Patients will be surveyed face-to-face in private hospital rooms, and 
patient participants will have the opportunity to include a legally authorized 
representative in the interview if desired. No minors will be included in the 
study. 
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.
 
Not applicable.  
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
 
Not applicable. 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
 
For the purposes of research dissemination, de-identified and aggregate data 
will be shared from external AMCs with Partners sites. These data will be 
shared on password-protected, secure servers at BWH.