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The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial

The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03576495
Acronym
PACTS
Enrollment
2901
Registered
2018-07-03
Start date
2019-07-01
Completion date
2022-06-30
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interpersonal and Communication Skills in Patient-clinician Encounters, Patient-reported Satisfaction With Resident Physicians Involved in Their Care, Patients' Clinical Health Outcomes After Surgery, Resident Knowledge and Attitudes Regarding Cross-cultural Care

Keywords

Medical education, Patient-reported satisfaction, Patient-reported outcomes, Cultural dexterity, Cross cultural care, Resident physician education

Brief 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 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.

Interventions

OTHERPACTS 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.

OTHERStandard Residency Curriculum

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.

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Massachusetts General Hospital
CollaboratorOTHER
Beth Israel Deaconess Medical Center
CollaboratorOTHER
Howard University
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
Brown University
CollaboratorOTHER
Eastern Virginia Medical School
CollaboratorOTHER
Washington University School of Medicine
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

Resident program directors and research staff will not be blinded to the implementation of curriculum

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\*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: * 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Residents' Cross Cultural Care Survey Scores From Pre- to Post-PACTS CurriculumPeriod 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 Their Beliefs From Pre- to Post-PACTS CurriculumPeriod 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 ScoresPeriod 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.
Change in Residents' Questionnaire Scores Measuring Knowledge From Pre- to Post-PACTS CurriculumPeriod 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' Questionnaire Scores Regarding Self-Assessed Skills From Pre- to Post-PACTS CurriculumPeriod 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.

Secondary

MeasureTime frameDescription
Median Hospital Length of Stay for Patient ParticipantsPeriod 2 (18 months)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.
Patients' Self-reported Satisfaction ScoresPeriod 2 (18 months)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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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

Participants by arm

ArmCount
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.
1,438
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.
4
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.
1,372
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.
4
Total2,818

Withdrawals & dropouts

PeriodReasonFG000FG001
Period 1 (0 Months)Lost to Follow-up5140

Baseline characteristics

CharacteristicEarly Intervention GroupDelayed Intervention GroupTotal
Age, Continuous
Patients
55.24 years
STANDARD_DEVIATION 17
56.07 years
STANDARD_DEVIATION 17.3
55.64 years
STANDARD_DEVIATION 17.17
Age, Continuous
Residents
30.1 years
STANDARD_DEVIATION 3.8
30.1 years
STANDARD_DEVIATION 3.8
30.1 years
STANDARD_DEVIATION 3.79
Education
Patients
Associates & Bachelors
350 Participants304 Participants654 Participants
Education
Patients
Master, Professional, and Doctorate
206 Participants148 Participants354 Participants
Education
Patients
No schooling, or completed to 1 or more years
700 Participants634 Participants1334 Participants
Education
Patients
Not disclosed
41 Participants112 Participants153 Participants
Education
Residents
Associates & Bachelors
0 Participants0 Participants0 Participants
Education
Residents
Master, Professional, and Doctorate
141 Participants174 Participants315 Participants
Education
Residents
No schooling, or completed to 1 or more years
0 Participants0 Participants0 Participants
Education
Residents
Not disclosed
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Patients
Hispanic or Latino
146 Participants53 Participants199 Participants
Ethnicity (NIH/OMB)
Patients
Not Hispanic or Latino
944 Participants1020 Participants1964 Participants
Ethnicity (NIH/OMB)
Patients
Unknown or Not Reported
207 Participants125 Participants332 Participants
Ethnicity (NIH/OMB)
Residents
Hispanic or Latino
15 Participants10 Participants25 Participants
Ethnicity (NIH/OMB)
Residents
Not Hispanic or Latino
123 Participants119 Participants242 Participants
Ethnicity (NIH/OMB)
Residents
Unknown or Not Reported
3 Participants45 Participants48 Participants
Race/Ethnicity, Customized
Patients
Asian
32 Participants30 Participants62 Participants
Race/Ethnicity, Customized
Patients
Black
269 Participants320 Participants589 Participants
Race/Ethnicity, Customized
Patients
Multiracial/other
172 Participants61 Participants233 Participants
Race/Ethnicity, Customized
Patients
Not disclosed
27 Participants8 Participants35 Participants
Race/Ethnicity, Customized
Patients
White
797 Participants779 Participants1576 Participants
Race/Ethnicity, Customized
Residents
Asian
28 Participants20 Participants48 Participants
Race/Ethnicity, Customized
Residents
Black
23 Participants11 Participants34 Participants
Race/Ethnicity, Customized
Residents
Multiracial/other
17 Participants14 Participants31 Participants
Race/Ethnicity, Customized
Residents
Not disclosed
0 Participants39 Participants39 Participants
Race/Ethnicity, Customized
Residents
White
73 Participants90 Participants163 Participants
Sex/Gender, Customized
Patient Sex/Gender
Female
601 Participants588 Participants1189 Participants
Sex/Gender, Customized
Patient Sex/Gender
Male
670 Participants605 Participants1275 Participants
Sex/Gender, Customized
Patient Sex/Gender
Non-Binary, Self-Describe, Not disclosed
26 Participants5 Participants31 Participants
Sex/Gender, Customized
Resident Sex/Gender
Female
69 Participants66 Participants135 Participants
Sex/Gender, Customized
Resident Sex/Gender
Male
72 Participants86 Participants158 Participants
Sex/Gender, Customized
Resident Sex/Gender
Non-Binary, Self-Describe, Not disclosed
0 Participants22 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 1920 / 2140 / 1,2970 / 1,198
other
Total, other adverse events
0 / 1920 / 2140 / 1,2970 / 1,198
serious
Total, serious adverse events
0 / 1920 / 2140 / 1,2970 / 1,198

Outcome results

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.

Time frame: Period 2 (18 months)

Population: 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.

ArmMeasureValue (NUMBER)
Early Intervention GroupChange in Residents' Cross Cultural Care Survey Scores From Pre- to Post-PACTS Curriculum88.2 percentage of participants
Delayed Intervention GroupChange in Residents' Cross Cultural Care Survey Scores From Pre- to Post-PACTS Curriculum88.2 percentage of participants
Comparison: We conducted a superiority statistical test to assess if residents' preparation for caring for culturally diverse patients improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident preparedness assessed by the Cross-Cultural Care Survey, resident preparedness was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups.p-value: 1Chi-squared
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.

Time frame: Period 2 (18 months)

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Early Intervention GroupChange in Residents' Questionnaire Scores Measuring Knowledge From Pre- to Post-PACTS Curriculum74.3 score on a scaleStandard Deviation 8.96
Delayed Intervention GroupChange in Residents' Questionnaire Scores Measuring Knowledge From Pre- to Post-PACTS Curriculum71.7 score on a scaleStandard Deviation 13.39
p-value: 0.2422t-test, 2 sided
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.

Time frame: Period 2 (18 months)

Population: 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.

ArmMeasureValue (NUMBER)
Early Intervention GroupChange in Residents' Questionnaire Scores Regarding Self-Assessed Skills From Pre- to Post-PACTS Curriculum85.0 percentage of skillful participants
Delayed Intervention GroupChange in Residents' Questionnaire Scores Regarding Self-Assessed Skills From Pre- to Post-PACTS Curriculum84.1 percentage of skillful participants
Comparison: We conducted a superiority statistical test to assess if residents' self-assessed skills improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident skills, resident skills were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups.p-value: 0.6295Chi-squared
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.

Time frame: Period 2 (18 months)

Population: 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.

ArmMeasureValue (NUMBER)
Early Intervention GroupChange in Residents' Questionnaire Scores Regarding Their Beliefs From Pre- to Post-PACTS Curriculum92.4 percentage of participants
Delayed Intervention GroupChange in Residents' Questionnaire Scores Regarding Their Beliefs From Pre- to Post-PACTS Curriculum89.9 percentage of participants
Comparison: We conducted a superiority statistical test to assess if residents' beliefs improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident beliefs, beliefs were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups.p-value: 0.0199Fisher Exact
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.

Time frame: Period 2 (18 months)

Population: 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

ArmMeasureGroupValue (NUMBER)
Early Intervention GroupObjective Structured Clinical Examination ScoresLimited English Proficiency/Informed Consent Period 260.9 difference in the percentage
Early Intervention GroupObjective Structured Clinical Examination ScoresTrust/Pain Period 258.6 difference in the percentage
Delayed Intervention GroupObjective Structured Clinical Examination ScoresLimited English Proficiency/Informed Consent Period 263.1 difference in the percentage
Delayed Intervention GroupObjective Structured Clinical Examination ScoresTrust/Pain Period 264.8 difference in the percentage
Comparison: We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Limited English Proficiency and Informed Consent OSCE.p-value: 0.2665Chi-squared
Comparison: We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Trust and Pain.p-value: 0.0001Chi-squared
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.

Time frame: Period 2 (18 months)

Population: 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.

ArmMeasureValue (MEDIAN)
Early Intervention GroupMedian Hospital Length of Stay for Patient Participants8.85 Days
Delayed Intervention GroupMedian Hospital Length of Stay for Patient Participants14.16 Days
Comparison: We conducted a superiority statistical test to assess if patients length of stay improved after resident exposure to the PACTS curriculum. Patient length of stay was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups to measure an effect of the PACTS intervention.p-value: 0.0028Wilcoxon (Mann-Whitney)
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.

Time frame: Period 2 (18 months)

Population: 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.

ArmMeasureGroupValue (NUMBER)
Early Intervention GroupPatients' Self-reported Satisfaction ScoresConsent Period 277.94 percentage of participants
Early Intervention GroupPatients' Self-reported Satisfaction ScoresTrust Period 272.06 percentage of participants
Early Intervention GroupPatients' Self-reported Satisfaction ScoresPain Period 281.0 percentage of participants
Early Intervention GroupPatients' Self-reported Satisfaction ScoresLimited English Proficiency Period 253.48 percentage of participants
Delayed Intervention GroupPatients' Self-reported Satisfaction ScoresPain Period 281.19 percentage of participants
Delayed Intervention GroupPatients' Self-reported Satisfaction ScoresLimited English Proficiency Period 251.56 percentage of participants
Delayed Intervention GroupPatients' Self-reported Satisfaction ScoresConsent Period 282.7 percentage of participants
Delayed Intervention GroupPatients' Self-reported Satisfaction ScoresTrust Period 275.25 percentage of participants
Comparison: We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to trust at time period 2.p-value: 0.5079Chi-squared
Comparison: We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the curriculum, patient satisfaction was compared at Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to limited English proficiency at period 2.p-value: 0.1571Chi-squared
Comparison: We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to consent at time period 2.p-value: 0.0001Chi-squared
Comparison: We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to pain at time period 2.p-value: 0.2956Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026