Resident Knowledge and Attitudes Regarding Cross-cultural CarePACTSNCT03576495
The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial
A study testing PACTS curriculum and Standard Residency Curriculum in people with Resident Knowledge and Attitudes Regarding Cross-cultural Care and Interpersonal and Communication Skills in Patient-clinician Encounters, run by Brigham and Women's Hospital at 8 sites in United States.
Trial summary
This study is designed to test the impact of a new curriculum, called Provider Awareness Cultural Dexterity Toolkit for Surgeons (PACTS), on surgical residents' cross-cultural knowledge, attitudes, and skills surrounding the care of patients from diverse cultural backgrounds, as well as clinical and patient-reported… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- PACTS curriculum and Standard Residency Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,901 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Jul 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All residents in the general surgery program at Johns Hopkins University, Brigham and Women's Hospital, Brown University, Eastern Virginia Medical School, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Howard University, and Washington University in St. Louis.
- Admitted to surgical service under the care of a participating resident;
- Able to recognize resident as the main care provider from a photo;
- Able to consent as determined by a cognitive screen for capacity to give informed consent
- Fluent in English or Spanish.
Who cannot join
- Non-surgical residents at Johns Hopkins University, Brigham and Women's Hospital, Brown University, Eastern Virginia Medical School, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Howard University, and Washington University in St. Louis.
- Eligibility Criteria for Patients:
- Admitted to Intensive Care;
- Mentally impaired and/or not oriented to person/time/ place.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Rhode Island Hospital
Providence, Rhode Island, 02905
Washington University in St. Louis
St Louis, Missouri, 63130
Howard University Hospital
Washington D.C., District of Columbia, 20059
About this study
This study is designed to test the impact of a new curriculum, called Provider Awareness Cultural Dexterity Toolkit for Surgeons (PACTS), on surgical residents' cross-cultural knowledge, attitudes, and skills surrounding the care of patients from diverse cultural backgrounds, as well as clinical and patient-reported health outcomes for patients treated by surgical residents undergoing this training.
Read the detailed description
In order to improve overall health outcomes of minority patients undergoing surgical care, the National Institute on Minority Health and Health Disparities (NIMHD) collaborated with the American College of Surgeons (ACS) and prioritized the evaluation and the the effect of improvement in culturally dexterous care on surgical outcomes for patients from disparity populations.
Poor outcomes in patients are attributed to poor patient-provider communication which may lead to treatment errors, inadequate pain management, less patient-centered care, decreased adherence to treatment plans, and worse overall clinical outcomes. Additionally, studies have shown that some surgeons have pro-White implicit biases, which are unconscious, automated preferences that individuals may not even be aware of.
Historically, formal training in cultural competency is generally integrated into medical education at the undergraduate level but it rarely continues up to the post-graduate level. Few surgical programs have attempted to incorporate cross-cultural communication skills into their educational paradigms, and the approaches to doing so have been inconsistent.
In order to add the surgical context in post-graduate level medical education, the investigators adopted 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 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.
Study design:
Cross-over, cluster-randomized trial
Study Procedures:
Curriculum Administration
The PACTS curriculum incorporates contemporary learning practices such as the "flipped classroom" model and team-based learning. It consists of e-learning modules and interactive sessions in which residents will apply concepts from the e-learning modules to role-play scenarios constructed in a team-based learning format. Residents will be given detailed, scripted prompts for the role-play sessions followed by structured feedback from peers and facilitators.
Outcome Measurement:
Residents
To evaluate the impact of PACTS on surgical residents' knowledge and attitudes about caring for diverse patients, the investigators 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.
Resident skills will also be objectively assessed through an Objective Structured Clinical Examination (OSCE) that will be created by the study staff and administered immediately before the intervention and 3 months after the intervention has been completed. The OSCE uses 5-point Likert scale questions to evaluate resident performance across multiple domains. These may be administered virtually or in-person.
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.
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, the investigators will 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 Patient Satisfactions Survey.
We plan to collect clinical surgical outcomes obtained from the National Surgical Quality Improvement Program (NSQIP) database 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. A post hoc analysis of clinical outcomes will be performed.
- 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
- Being tested
- PACTS curriculum, Standard Residency Curriculum
- Keywords
- Medical education, Patient-reported satisfaction, Patient-reported outcomes, Cultural dexterity, Cross cultural care, Resident physician education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACTS curriculumOther
The 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.
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.
Standard Residency CurriculumOther
The standard residency curriculum consists of previously scheduled resident didactic sessions at all academic medical centers that may or may not include topics on cultural competency or cross-cultural care.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention Group | Experimental | The investigators will assess the residents' knowledge, attitudes, and skills prior to and after the PACTS curriculum administration at half the sites (Early Intervention Group). Evaluation results in the Early Intervention Group will be compared to the Delayed Intervention (Active Comparator) group at time Period 2. Receives: Other: PACTS curriculum |
| Delayed Intervention Group | Active comparator | The investigators will conduct baseline testing prior to the standard residency curriculum. These results will be compared to the Early Intervention Group (Experimental Group) at time period 2. Receives: Other: Standard Residency Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Residents' Questionnaire Scores Measuring Knowledge From Pre- to Post-PACTS Curriculum
The effect of PACTS curriculum on surgical residents' questionnaire scores measuring knowledge about caring for culturally diverse patients at time Period 2 (18 months). At this time, the Early Intervention Group had already received the PACTS curriculum. The Delayed Intervention Group had not received the PACTS curriculum, serving as the control group at this time period.
Resident knowledge: Percent score out of 100, with range 0-100%. Higher values represent a better outcome, with 100% as the highest score possible. This is the average score for the Early Intervention and Delayed Intervention groups at Period 2.
Measured: Period 2 (18 months)
Change in Residents' Cross Cultural Care Survey Scores From Pre- to Post-PACTS Curriculum
The effect of PACTS curriculum on surgical residents' cross cultural care survey about caring for culturally diverse patients at time Period 2 (18 months). At this time period, the Early Intervention group received the PACTS curriculum, while the Delayed Intervention Group had not received the PACTS curriculum, serving as the control group. The cross cultural care survey was evaluated using a modified Likert type scale (with scale ranging from lowest to highest: very unprepared, somewhat unprepared, somewhat prepared, very well prepared). Resident scores were dichotomized into two groups, those reporting "very unprepared" and "somewhat unprepared", and those reporting "somewhat prepared" and "very well prepared." Here reported values are representative of the percentage of participants who reported "somewhat prepared" and "very well prepared" at time Period 2.
Measured: Period 2 (18 months)
Change in Residents' Questionnaire Scores Regarding Self-Assessed Skills From Pre- to Post-PACTS Curriculum
The effect of PACTS curriculum on surgical residents' self-assessed skills for caring for culturally diverse patients at time Period 2 (18 months). Self-assessed skills ranged from levels 1 to levels 4, with level 1 indicated less skilled, and level 4 indicating skillful. For purposes of comparison, resident scores were dichotomized into two groups: less skilled (referring to skill levels 1 and 2), and skillful (levels 3 and 4). Here reported values are representative of the percentage of participants who reported skill levels 3 or 4, indicating skillful. Results here demonstrate the proportion of residents in the Early Intervention (Intervention) group and Delayed Intervention (control group) who self-evaluated their skills as skillful at Period 2.
Measured: Period 2 (18 months)
Change in Residents' Questionnaire Scores Regarding Their Beliefs From Pre- to Post-PACTS Curriculum
The effect of PACTS curriculum on surgical residents' beliefs regarding caring for culturally diverse patients at time Period 2 (18 months). At this time, the Early Intervention Group had already received the PACTS curriculum. The Delayed Intervention Group had not received the PACTS curriculum, serving as the control group at this time period. The questionnaire was scored using a modified Likert type scale with a range from lowest to highest: strongly disagree, moderately disagree, mildly disagree, strongly agree, moderately agree, mildly agree. Answers were dichotomized into two groups: strongly disagree, moderately disagree, and mildly disagree; and strongly agree, moderately agree, and mildly agree. Here reported values are representative of the proportion of participants who answered "strongly agree, moderately agree, and mildly agree."
Measured: Period 2 (18 months)
Objective Structured Clinical Examination Scores
Standardized Patient observers evaluated surgical residents on multiple dimensions of cultural dexterity and communication skills using Likert-type scales. The scale range, from lowest to highest was: "Not at all; a little bit; somewhat; mostly; a great deal." Scores were put into two groups: 1) not at all, a little bit, and somewhat; 2) mostly and a great deal. The percentage of residents who received scores of "mostly" and "a great deal" in categories of trust, limited english proficiency, consent, and pain were reported.
Measured: Period 2 (18 months)
Secondary outcomes (2)
Patients' Self-reported Satisfaction Scores
We used an adapted version of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) to assess patients' (1) satisfaction with pain management, (2) satisfaction with communication including specific measures for limited English proficiency (LEP), (3) trust, and (4) comprehension of informed consent. Patient satisfaction was captured using a modified Likert scale from lowest to highest: strongly disagree, disagree, neither agree nor disagree, agree, and strongly agree. The values reported below are the percentage of participants who reported "agree" or "strongly agree."
Measured: Period 2 (18 months)
Median Hospital Length of Stay for Patient Participants
National Surgical Quality Improvement Program (NSQIP) metrics for each patient participant capturing hospital length of stay in days. Patients designated to Early Intervention Group were cared for by a resident enrolled in the Early Intervention group, where the PACTS curriculum was administered between period 1 (0 months) and period 2 (18 months). Patients designated to the Delayed Intervention group were cared for by a resident enrolled in the Delayed Intervention group, where the standard curriculum was administered between period 1 (0 months) and period 2 (18 months). We are comparing median length of stay at period 2.
Measured: Period 2 (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start1 Jul 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Resident Knowledge and Attitudes Regarding Cross-cultural CareStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Sites will be assigned to an early intervention/retention assessment group or a delayed intervention group (control) for examination of the effectiveness of the intervention as well as learner retention.
- Masking
- None (open label)
- Enrolment
- 2,901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Howard University, Johns Hopkins University, Brown University, Eastern Virginia Medical School, Washington University School of Medicine
- Responsible party
- Principal investigator, Adil Haider, Brigham and Women's Hospital
- Investigators
- Adil Haider, MD, MPH, Principal investigator, Brigham and Women's HospitalDouglas Smink, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576495
- Sponsor's protocol ID
- 2018P001237
- Other IDs
- 1R01MD011685-01A1
- Acronym
- PACTS
- Status last verified
- May 2024
- First submitted
- 13 Jun 2018
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haider AH, Weygandt PL, Bentley JM, Monn MF, Rehman KA, Zarzaur BL, Crandall ML, Cornwell EE, Cooper LA. Disparities in trauma care and outcomes in the United States: a systematic review and meta-analysis. J Trauma Acute Care Surg. 2013 May;74(5):1195-205. doi: 10.1097/TA.0b013e31828c331d.
PubMed 23609267Haider AH, Scott VK, Rehman KA, Velopulos C, Bentley JM, Cornwell EE 3rd, Al-Refaie W. Racial disparities in surgical care and outcomes in the United States: a comprehensive review of patient, provider, and systemic factors. J Am Coll Surg. 2013 Mar;216(3):482-92.e12. doi: 10.1016/j.jamcollsurg.2012.11.014. Epub 2013 Jan 11.
PubMed 23318117Torain MJ, Maragh-Bass AC, Dankwa-Mullen I, Hisam B, Kodadek LM, Lilley EJ, Najjar P, Changoor NR, Rose JA Jr, Zogg CK, Maddox YT, Britt LD, Haider AH. Surgical Disparities: A Comprehensive Review and New Conceptual Framework. J Am Coll Surg. 2016 Aug;223(2):408-18. doi: 10.1016/j.jamcollsurg.2016.04.047. Epub 2016 Jun 10. No abstract available.
PubMed 27296524Cooper LA, Roter DL, Carson KA, Beach MC, Sabin JA, Greenwald AG, Inui TS. The associations of clinicians' implicit attitudes about race with medical visit communication and patient ratings of interpersonal care. Am J Public Health. 2012 May;102(5):979-87. doi: 10.2105/AJPH.2011.300558. Epub 2012 Mar 15.
PubMed 22420787Betancourt JR, Green AR, Carrillo JE, Ananeh-Firempong O 2nd. Defining cultural competence: a practical framework for addressing racial/ethnic disparities in health and health care. Public Health Rep. 2003 Jul-Aug;118(4):293-302. doi: 10.1093/phr/118.4.293.
PubMed 12815076Betancourt JR, Green AR, Carrillo JE, Park ER. Cultural competence and health care disparities: key perspectives and trends. Health Aff (Millwood). 2005 Mar-Apr;24(2):499-505. doi: 10.1377/hlthaff.24.2.499.
PubMed 15757936Horvat L, Horey D, Romios P, Kis-Rigo J. Cultural competence education for health professionals. Cochrane Database Syst Rev. 2014 May 5;2014(5):CD009405. doi: 10.1002/14651858.CD009405.pub2.
PubMed 24793445Weissman JS, Betancourt J, Campbell EG, Park ER, Kim M, Clarridge B, Blumenthal D, Lee KC, Maina AW. Resident physicians' preparedness to provide cross-cultural care. JAMA. 2005 Sep 7;294(9):1058-67. doi: 10.1001/jama.294.9.1058.
PubMed 16145026Shah SS, Sapigao FB 3rd, Chun MBJ. An Overview of Cultural Competency Curricula in ACGME-accredited General Surgery Residency Programs. J Surg Educ. 2017 Jan-Feb;74(1):16-22. doi: 10.1016/j.jsurg.2016.06.017. Epub 2016 Sep 20.
PubMed 27663082Haider AH, Dankwa-Mullan I, Maragh-Bass AC, Torain M, Zogg CK, Lilley EJ, Kodadek LM, Changoor NR, Najjar P, Rose JA Jr, Ford HR, Salim A, Stain SC, Shafi S, Sutton B, Hoyt D, Maddox YT, Britt LD. Setting a National Agenda for Surgical Disparities Research: Recommendations From the National Institutes of Health and American College of Surgeons Summit. JAMA Surg. 2016 Jun 1;151(6):554-63. doi: 10.1001/jamasurg.2016.0014.
PubMed 26982380Allar BG, Ortega G, Chun MBJ, Rodriguez JGZ, Mullen JT, Lynch KA Jr, Harrington DT, Green AR, Lipsett PA, Britt LD, Haider AH, Smink DS, Kent TS; PACTS Trial Group. Changing Surgical Culture Through Surgical Education: Introduction to the PACTS Trial. J Surg Educ. 2024 Mar;81(3):330-334. doi: 10.1016/j.jsurg.2023.11.018. Epub 2023 Dec 23.
PubMed 38142149Khubchandani JA, Atkinson RB, Ortega G, Reidy E, Mullen JT, Smink DS; PACTS Trial Group. Perceived Discrimination Among Surgical Residents at Academic Medical Centers. J Surg Res. 2022 Apr;272:79-87. doi: 10.1016/j.jss.2021.10.029. Epub 2021 Dec 20.
PubMed 34942508
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial
- ClinicalTrials.gov ID
- NCT03576495
- Acronym / sponsor ID
- PACTS / 2018P001237
- 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
- Keywords
- Medical education, Patient-reported satisfaction, Patient-reported outcomes, Cultural dexterity, Cross cultural care, Resident physician education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,901 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Howard University, Johns Hopkins University, Brown University, Eastern Virginia Medical School, Washington University School of Medicine
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the impact of a new curriculum, called Provider Awareness Cultural Dexterity Toolkit for Surgeons (PACTS), on surgical residents' cross-cultural knowledge, attitudes, and skills surrounding the care of patients from diverse cultural backgrounds, as well as clinical and patient-reported health outcomes for patients treated by surgical residents undergoing this training.
Detailed description
In order to improve overall health outcomes of minority patients undergoing surgical care, the National Institute on Minority Health and Health Disparities (NIMHD) collaborated with the American College of Surgeons (ACS) and prioritized the evaluation and the the effect of improvement in culturally dexterous care on surgical outcomes for patients from disparity populations.
Poor outcomes in patients are attributed to poor patient-provider communication which may lead to treatment errors, inadequate pain management, less patient-centered care, decreased adherence to treatment plans, and worse overall clinical outcomes. Additionally, studies have shown that some surgeons have pro-White implicit biases, which are unconscious, automated preferences that individuals may not even be aware of.
Historically, formal training in cultural competency is generally integrated into medical education at the undergraduate level but it rarely continues up to the post-graduate level. Few surgical programs have attempted to incorporate cross-cultural communication skills into their educational paradigms, and the approaches to doing so have been inconsistent.
In order to add the surgical context in post-graduate level medical education, the investigators adopted 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 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.
Study design:
Cross-over, cluster-randomized trial
Study Procedures:
Curriculum Administration
The PACTS curriculum incorporates contemporary learning practices such as the "flipped classroom" model and team-based learning. It consists of e-learning modules and interactive sessions in which residents will apply concepts from the e-learning modules to role-play scenarios constructed in a team-based learning format. Residents will be given detailed, scripted prompts for the role-play sessions followed by structured feedback from peers and facilitators.
Outcome Measurement:
Residents
To evaluate the impact of PACTS on surgical residents' knowledge and attitudes about caring for diverse patients, the investigators 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.
Resident skills will also be objectively assessed through an Objective Structured Clinical Examination (OSCE) that will be created by the study staff and administered immediately before the intervention and 3 months after the intervention has been completed. The OSCE uses 5-point Likert scale questions to evaluate resident performance across multiple domains. These may be administered virtually or in-person.
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.
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, the investigators will 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 Patient Satisfactions Survey.
We plan to collect clinical surgical outcomes obtained from the National Surgical Quality Improvement Program (NSQIP) database 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. A post hoc analysis of clinical outcomes will be performed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sites will be assigned to an early intervention/retention assessment group or a delayed intervention group (control) for examination of the effectiveness of the intervention as well as learner retention.
| Arm | Type | Receives |
|---|---|---|
| Early Intervention Group | Experimental | Other: PACTS curriculumThe investigators will assess the residents' knowledge, attitudes, and skills prior to and after the PACTS curriculum administration at half the sites (Early Intervention Group). Evaluation results in the Early Intervention Group will be compared to the Delayed Intervention (Active Comparator) group at time Period 2. |
| Delayed Intervention Group | Active comparator | Other: Standard Residency CurriculumThe investigators will conduct baseline testing prior to the standard residency curriculum. These results will be compared to the Early Intervention Group (Experimental Group) at time period 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All residents in the general surgery program at Johns Hopkins University, Brigham and Women's Hospital, Brown University, Eastern Virginia Medical School, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Howard University, and Washington University in St. Louis.
- Admitted to surgical service under the care of a participating resident;
- Able to recognize resident as the main care provider from a photo;
- Able to consent as determined by a cognitive screen for capacity to give informed consent
- Fluent in English or Spanish.
Key exclusion criteria (4 listed)
- Non-surgical residents at Johns Hopkins University, Brigham and Women's Hospital, Brown University, Eastern Virginia Medical School, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Howard University, and Washington University in St. Louis.
- Admitted to Intensive Care;
- Mentally impaired and/or not oriented to person/time/ place.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACTS curriculumThe 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. 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. | Other | Early Intervention Group |
| Standard Residency CurriculumThe standard residency curriculum consists of previously scheduled resident didactic sessions at all academic medical centers that may or may not include topics on cultural competency or cross-cultural care. | Other | Delayed Intervention Group |
Primary outcome
Change in Residents' Questionnaire Scores Measuring Knowledge From Pre- to Post-PACTS Curriculum
Time frame: Period 2 (18 months)
The effect of PACTS curriculum on surgical residents' questionnaire scores measuring knowledge about caring for culturally diverse patients at time Period 2 (18 months). At this time, the Early Intervention Group had already received the PACTS curriculum. The Delayed Intervention Group had not received the PACTS curriculum, serving as the control group at this time period. Resident knowledge: Percent score out of 100, with range 0-100%. Higher values represent a better outcome, with 100% as the highest score possible. This is the average score for the Early Intervention and Delayed Intervention groups at Period 2.
Change in Residents' Cross Cultural Care Survey Scores From Pre- to Post-PACTS Curriculum
Time frame: Period 2 (18 months)
The effect of PACTS curriculum on surgical residents' cross cultural care survey about caring for culturally diverse patients at time Period 2 (18 months). At this time period, the Early Intervention group received the PACTS curriculum, while the Delayed Intervention Group had not received the PACTS curriculum, serving as the control group. The cross cultural care survey was evaluated using a modified Likert type scale (with scale ranging from lowest to highest: very unprepared, somewhat unprepared, somewhat prepared, very well prepared). Resident scores were dichotomized into two groups, those reporting "very unprepared" and "somewhat unprepared", and those reporting "somewhat prepared" and "very well prepared." Here reported values are representative of the percentage of participants who reported "somewhat prepared" and "very well prepared" at time Period 2.
Change in Residents' Questionnaire Scores Regarding Self-Assessed Skills From Pre- to Post-PACTS Curriculum
Time frame: Period 2 (18 months)
The effect of PACTS curriculum on surgical residents' self-assessed skills for caring for culturally diverse patients at time Period 2 (18 months). Self-assessed skills ranged from levels 1 to levels 4, with level 1 indicated less skilled, and level 4 indicating skillful. For purposes of comparison, resident scores were dichotomized into two groups: less skilled (referring to skill levels 1 and 2), and skillful (levels 3 and 4). Here reported values are representative of the percentage of participants who reported skill levels 3 or 4, indicating skillful. Results here demonstrate the proportion of residents in the Early Intervention (Intervention) group and Delayed Intervention (control group) who self-evaluated their skills as skillful at Period 2.
Change in Residents' Questionnaire Scores Regarding Their Beliefs From Pre- to Post-PACTS Curriculum
Time frame: Period 2 (18 months)
The effect of PACTS curriculum on surgical residents' beliefs regarding caring for culturally diverse patients at time Period 2 (18 months). At this time, the Early Intervention Group had already received the PACTS curriculum. The Delayed Intervention Group had not received the PACTS curriculum, serving as the control group at this time period. The questionnaire was scored using a modified Likert type scale with a range from lowest to highest: strongly disagree, moderately disagree, mildly disagree, strongly agree, moderately agree, mildly agree. Answers were dichotomized into two groups: strongly disagree, moderately disagree, and mildly disagree; and strongly agree, moderately agree, and mildly agree. Here reported values are representative of the proportion of participants who answered "strongly agree, moderately agree, and mildly agree."
Objective Structured Clinical Examination Scores
Time frame: Period 2 (18 months)
Standardized Patient observers evaluated surgical residents on multiple dimensions of cultural dexterity and communication skills using Likert-type scales. The scale range, from lowest to highest was: "Not at all; a little bit; somewhat; mostly; a great deal." Scores were put into two groups: 1) not at all, a little bit, and somewhat; 2) mostly and a great deal. The percentage of residents who received scores of "mostly" and "a great deal" in categories of trust, limited english proficiency, consent, and pain were reported.
2 secondary outcomes
Patients' Self-reported Satisfaction Scores
Time frame: Period 2 (18 months)
Median Hospital Length of Stay for Patient Participants
Time frame: Period 2 (18 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23609267Haider AH, Weygandt PL, Bentley JM, Monn MF, Rehman KA, Zarzaur BL, Crandall ML, Cornwell EE, Cooper LA. Disparities in trauma care and outcomes in the United States: a systematic review and meta-analysis. J Trauma Acute Care Surg. 2013 May;74(5):1195-205. doi: 10.1097/TA.0b013e31828c331d.
- Background: PubMed 23318117Haider AH, Scott VK, Rehman KA, Velopulos C, Bentley JM, Cornwell EE 3rd, Al-Refaie W. Racial disparities in surgical care and outcomes in the United States: a comprehensive review of patient, provider, and systemic factors. J Am Coll Surg. 2013 Mar;216(3):482-92.e12. doi: 10.1016/j.jamcollsurg.2012.11.014. Epub 2013 Jan 11.
- Background: PubMed 27296524Torain MJ, Maragh-Bass AC, Dankwa-Mullen I, Hisam B, Kodadek LM, Lilley EJ, Najjar P, Changoor NR, Rose JA Jr, Zogg CK, Maddox YT, Britt LD, Haider AH. Surgical Disparities: A Comprehensive Review and New Conceptual Framework. J Am Coll Surg. 2016 Aug;223(2):408-18. doi: 10.1016/j.jamcollsurg.2016.04.047. Epub 2016 Jun 10. No abstract available.
- Background: PubMed 22420787Cooper LA, Roter DL, Carson KA, Beach MC, Sabin JA, Greenwald AG, Inui TS. The associations of clinicians' implicit attitudes about race with medical visit communication and patient ratings of interpersonal care. Am J Public Health. 2012 May;102(5):979-87. doi: 10.2105/AJPH.2011.300558. Epub 2012 Mar 15.
- Background: PubMed 12815076Betancourt JR, Green AR, Carrillo JE, Ananeh-Firempong O 2nd. Defining cultural competence: a practical framework for addressing racial/ethnic disparities in health and health care. Public Health Rep. 2003 Jul-Aug;118(4):293-302. doi: 10.1093/phr/118.4.293.
- Background: PubMed 15757936Betancourt JR, Green AR, Carrillo JE, Park ER. Cultural competence and health care disparities: key perspectives and trends. Health Aff (Millwood). 2005 Mar-Apr;24(2):499-505. doi: 10.1377/hlthaff.24.2.499.
- Background: PubMed 24793445Horvat L, Horey D, Romios P, Kis-Rigo J. Cultural competence education for health professionals. Cochrane Database Syst Rev. 2014 May 5;2014(5):CD009405. doi: 10.1002/14651858.CD009405.pub2.
- Background: PubMed 16145026Weissman JS, Betancourt J, Campbell EG, Park ER, Kim M, Clarridge B, Blumenthal D, Lee KC, Maina AW. Resident physicians' preparedness to provide cross-cultural care. JAMA. 2005 Sep 7;294(9):1058-67. doi: 10.1001/jama.294.9.1058.
- Background: PubMed 27663082Shah SS, Sapigao FB 3rd, Chun MBJ. An Overview of Cultural Competency Curricula in ACGME-accredited General Surgery Residency Programs. J Surg Educ. 2017 Jan-Feb;74(1):16-22. doi: 10.1016/j.jsurg.2016.06.017. Epub 2016 Sep 20.
- Background: PubMed 26982380Haider AH, Dankwa-Mullan I, Maragh-Bass AC, Torain M, Zogg CK, Lilley EJ, Kodadek LM, Changoor NR, Najjar P, Rose JA Jr, Ford HR, Salim A, Stain SC, Shafi S, Sutton B, Hoyt D, Maddox YT, Britt LD. Setting a National Agenda for Surgical Disparities Research: Recommendations From the National Institutes of Health and American College of Surgeons Summit. JAMA Surg. 2016 Jun 1;151(6):554-63. doi: 10.1001/jamasurg.2016.0014.
- Derived from this study: PubMed 38142149Allar BG, Ortega G, Chun MBJ, Rodriguez JGZ, Mullen JT, Lynch KA Jr, Harrington DT, Green AR, Lipsett PA, Britt LD, Haider AH, Smink DS, Kent TS; PACTS Trial Group. Changing Surgical Culture Through Surgical Education: Introduction to the PACTS Trial. J Surg Educ. 2024 Mar;81(3):330-334. doi: 10.1016/j.jsurg.2023.11.018. Epub 2023 Dec 23.
- Derived from this study: PubMed 34942508Khubchandani JA, Atkinson RB, Ortega G, Reidy E, Mullen JT, Smink DS; PACTS Trial Group. Perceived Discrimination Among Surgical Residents at Academic Medical Centers. J Surg Res. 2022 Apr;272:79-87. doi: 10.1016/j.jss.2021.10.029. Epub 2021 Dec 20.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adil Haider, MD, MPH principal investigator
Brigham and Women's Hospital
Douglas Smink, MD, MPH principal investigator
Brigham and Women's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACTS curriculum and Standard Residency Curriculum in people with Resident Knowledge and Attitudes Regarding Cross-cultural Care and Interpersonal and Communication Skills in Patient-clinician Encounters, run by Brigham and Women's Hospital at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Residents' Questionnaire Scores Measuring Knowledge From Pre- to Post-PACTS Curriculum (time frame: Period 2 (18 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03576495, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.