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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD011685-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Massachusetts General Hospital | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PACTS curriculum | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
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*Eligibility Criteria for Residents:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adil Haider, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Douglas Smink, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Howard University Hospital | Washington D.C. | District of Columbia | 20059 | United States | ||
| Johns Hopkins Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23609267 | Background | 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. | |
| 23318117 | Background | Haider 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. |
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Inclusion criteria (Residents): All general surgery residents at all participating sites Exclusion criteria (Residents): All non-surgical residents at all participating sites
Inclusion criteria (Patients): Admitted to a surgical service under the care of a participating resident with the capacity to give informed consent Exclusion criteria (Patients): Mentally impaired, admitted to intensive care
Recruitment of general surgery residents and surgical patients at Johns Hopkins University, Brigham and Women's Hospital, Brown University, and Eastern Virginia Medical School, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Howard University, and Washington University in St. Louis. We randomized at the site level to two groups: Early Intervention and Delayed Intervention. We reported our aggregate results for the residents and surgical patients in each group.
| ID | Title | Description |
|---|---|---|
| FG000 | Early Intervention Group | Residency sites (and in turn its residents) designated to the Early Intervention group will undergo assessment to evaluate residents' knowledge, attitudes, and skills prior to and after the PACTS curriculum administration. Follow-up testing will be conducted after one year to evaluate learner retention. Patients in the Early Intervention Group are patients who are cared for by a resident physician enrolled into the early intervention group, and monitors their patient satisfaction as well as clinical outcomes before and after the PACTS curriculum. PACTS curriculum: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (0 Months) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2020 | Aug 3, 2023 |
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| Howard University |
| OTHER |
| Johns Hopkins University | OTHER |
| Brown University | OTHER |
| Eastern Virginia Medical School | OTHER |
| Washington University School of Medicine | OTHER |
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.
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Resident program directors and research staff will not be blinded to the implementation of curriculum
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|
| Standard Residency Curriculum | Other | 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. |
|
| 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." | 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. | Period 2 (18 months) |
| 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. | Period 2 (18 months) |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02905 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| 27296524 | Background | Torain 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. |
| 22420787 | Background | Cooper 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. |
| 12815076 | Background | Betancourt 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. |
| 15757936 | Background | Betancourt 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. |
| 24793445 | Background | Horvat 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. |
| 16145026 | Background | Weissman 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. |
| 27663082 | Background | Shah 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. |
| 26982380 | Background | Haider 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. |
| 38142149 | Derived | Allar 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. |
| 34942508 | Derived | Khubchandani 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. |
| FG001 | Delayed Intervention Group | Residency sites and its participating residents designated to the delayed intervention group underwent baseline testing prior to the standard residency curriculum, and then received the PACTS curriculum the following year. Both between- and within-group differences will be examined 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. Patients designated to the Delayed Intervention Group are cared for by a resident physician enrolled into the delayed intervention group, and monitors their patient satisfaction as well as clinical outcomes before and after the PACTS curriculum. PACTS curriculum: 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. |
| Residents |
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| Patients |
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| COMPLETED |
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| NOT COMPLETED |
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| Period 2 (18 Months) |
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| Period 3 (36 Months) |
|
A total of 8 residency sites were enrolled: 4 were designated to the Early Intervention group, and 4 were designated to the Delayed Intervention group. The baseline participants includes residents and patients.
| ID | Title | Description |
|---|---|---|
| BG000 | Early Intervention Group | Residency sites and its residents designated to the Early Intervention group will undergo assessment to evaluate residents' knowledge, attitudes, and skills prior to and after the PACTS curriculum administration. Follow-up testing will be conducted after one year to evaluate learner retention. Patients in the Early Intervention Group are patients who are cared for by a resident physician enrolled into the early intervention group, and monitors their patient satisfaction as well as clinical outcomes before and after the PACTS curriculum. PACTS curriculum: 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. |
| BG001 | Delayed Intervention Group | Residency sites and its participating residents designated to the delayed intervention group underwent baseline testing prior to the standard residency curriculum, and then received the PACTS curriculum the following year. Both between- and within-group differences will be examined 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. Patients designated to the Delayed Intervention Group are cared for by a resident physician enrolled into the delayed intervention group, and monitors their patient satisfaction as well as clinical outcomes before and after the PACTS curriculum. PACTS curriculum: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Residency Sites |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The number of participants analyzed differs from the number enrolled due to loss to follow up. | Mean | Standard Deviation | years | Participants |
| ||||||||
| Sex/Gender, Customized | The number of participants enrolled differed from the number analyzed due to loss to follow up. | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | The number of participants analyzed differs from the number enrolled due to loss to follow up | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | The number of participants analyzed differs from the number enrolled due to loss to follow up. | Count of Participants | Participants | Participants |
| |||||||||
| Education | The number of analyzed differs from the number enrolled due to loss to follow up. The participants in the Early and Delayed Resident Groups are all physicians and therefore, are categorized as Master, Professional, and Doctorate degree level for education. | Count of Participants | Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Mean resident knowledge scores (from 0-100%) for surgical residents in both the Early Intervention and Delayed Intervention groups at Period 2 (18 months). Of the residents who completed the trial (141 for Early Intervention Group; 174 for Delayed Intervention Group), only 52 residents in the Early Intervention and 55 residents in the Delayed Intervention Group participated in the resident assessment at Period 2. | Posted | Mean | Standard Deviation | score on a scale | Period 2 (18 months) |
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| Primary | 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. | Percentage of residents who reported "somewhat prepared" and "very well prepared" for the cross cultural survey in both the Early Intervention and Delayed Intervention groups at time period 2. Of the residents who completed the trial (141 for Early Intervention Group; 174 for Delayed Intervention Group), only 52 residents in the Early Intervention and 55 residents in the Delayed Intervention Group completed the Cross Cultural Care Survey at Period 2. | Posted | Number | percentage of participants | Period 2 (18 months) |
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| Primary | 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. | Of the residents who completed the trial (141 for Early Intervention Group; 174 for Delayed Intervention Group), only 52 residents in the Early Intervention and 55 residents in the Delayed Intervention Group participated in the questionnaire regarding self-assessed skills. | Posted | Number | percentage of "skillful" participants | Period 2 (18 months) |
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| Primary | 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." | Of the residents who completed the trial (141 for Early Intervention Group; 174 for Delayed Intervention Group), only 52 residents in the Early Intervention and 55 residents in the Delayed Intervention Group completed the questionnaire on beliefs at time Period 2. | Posted | Number | percentage of participants | Period 2 (18 months) |
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| Primary | 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. | Of the residents who completed the trial (141 for Early Intervention Group; 174 for Delayed Intervention Group), only 59 residents in the Early Intervention and 111 residents in the Delayed Intervention Group completed the the OSCE at Period 2. Only 105 residents performed the OSCE on Limited English Proficiency in the Delayed Group | Posted | Number | difference in the percentage | Period 2 (18 months) |
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| Secondary | 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." | Patient reported satisfaction surveys at Periods 2 (18 months). Of the 1297 patients in the Early Intervention Group, and 1198 patients in the Delayed Intervention Group, only 436 patients and 392 patients, respectively, completed the survey at Period 2. | Posted | Number | percentage of participants | Period 2 (18 months) |
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| Secondary | 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. | Comparison of length of stay for patients admitted to the hospital and cared for by residents in the early versus delayed intervention groups. The analysis population differs from the overall number of patients because not all patients had a recorded length of stay. Of those that we had length of stay data for, there were 255 participants in the Early Intervention group at Period 2, and 386 participants in the Delayed Intervention group at Period 2. | Posted | Median | Inter-Quartile Range | Days | Period 2 (18 months) |
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The entirety of the trial was 36 months, divided into 3 periods: period 1 (0 months), period 2 (18 months), and period 3 (36 months).
Our definition of an adverse event is consistent with that of clinical trials.gov. Our trial did not involve more than a minimal-risk intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Early Intervention / Retention Group, Residents | Residents in the Early Intervention Group undergo baseline assessment at period 1 (0 months) followed by the PACTS curriculum, with subsequent assessment at period 2 (18 months) and period 3 (36 months). PACTS curriculum: 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. | 0 | 192 | 0 | 192 | 0 | 192 |
| EG001 | Delayed Intervention Group, Residents | Residents in the Delayed Intervention Group undergo baseline assessment at period 1 (0 months) followed by the standard curriculum, with subsequent assessment at period 2 (18 months). They then receive the PACTS curriculum with subsequent evaluation at period 3 (36 months). PACTS curriculum: 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. | 0 | 214 | 0 | 214 | 0 | 214 |
| EG002 | Early Intervention Group, Patients | This corresponds to patients who were cared for by residents who were designated to the Early Intervention Group. | 0 | 1,297 | 0 | 1,297 | 0 | 1,297 |
| EG003 | Delayed Intervention Group, Patients | This corresponds to patients who were cared for by residents who were designated to the Delayed Intervention Group. | 0 | 1,198 | 0 | 1,198 | 0 | 1,198 |
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Duration of trial was impacted by the COVID-19 pandemic, leading to prolonged enrollment time (36 months) as opposed to intended 18 month study duration. Educational interventions and assessments were modified to a virtual platform.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Douglas S. Smink | Brigham and Women's Hospital | 617-983-7260 | dsmink@bwh.harvard.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2017 | Aug 3, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 21, 2023 | Aug 3, 2023 | ICF_002.pdf |
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| OG001 | Delayed Intervention Group | At 18 months (Period 2), resident cross cultural care was assessed after the standard residency curriculum. |
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| OG001 | Delayed Intervention Group | At 18 months (Period 2), residents self-assessed skills were assessed after the standard residency curriculum. |
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| OG001 | Delayed Intervention Group | The investigators will evaluate surgical residents' beliefs regarding providing cross cultural care after the standard residency curriculum at 18 months (Period 2). |
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| OG001 | Delayed Intervention Group (Residents) | Residents assigned to the Delayed Intervention group participated in Objective Structure Clinical Examinations where they are assessed by a Standardized Patient on dimensions of cultural dexterity and communication skills using Likert-type scales. Results from Period 2 (18 months) were after residents received the standard curriculum. |
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| OG001 | Delayed Intervention Group | The investigators will evaluate patient reported satisfaction amongst patients who were cared for by residents who had received the standard residency curriculum. Patients designated to the Delayed Intervention Group were cared for by a resident enrolled in the Delayed Intervention group. |
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| OG001 | Delayed Intervention Group (Patients) | The investigators will conduct testing after the standard residency curriculum at time Period 2 (18 months). These data are from patients who are cared for by residents enrolled in the Delayed Intervention Group. |
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| Non-Binary, Self-Describe, Not disclosed |
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| Unknown or Not Reported |
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| Asian |
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| Master, Professional, and Doctorate |
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