Clinical trial NCT03576495: The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial
Official title: The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resident Knowledge and Attitudes Regarding Cross-cultural Care
Interpersonal and Communication Skills in Patient-clinician Encounters
Patient-reported Satisfaction With Resident Physicians Involved in Their Care
Patients' Clinical Health Outcomes After Surgery
Keywords: Medical education
Patient-reported satisfaction
Patient-reported outcomes
Cultural dexterity
Cross cultural care
Resident physician education
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
name: Howard University
name: Johns Hopkins University
name: Brown University
name: Eastern Virginia Medical School
name: Washington University School of Medicine
First posted: 2018-07-03
Enrollment: 2901
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Exclusion Criteria:

* Admitted to Intensive Care;
* Mentally impaired and/or not oriented to person/time/ place.

Primary outcomes:
measure: Change in Residents' Questionnaire Scores Measuring Knowledge From Pre- to Post-PACTS Curriculum
timeFrame: Period 2 (18 months)
measure: Change in Residents' Cross Cultural Care Survey Scores From Pre- to Post-PACTS Curriculum
timeFrame: Period 2 (18 months)
measure: Change in Residents' Questionnaire Scores Regarding Self-Assessed Skills From Pre- to Post-PACTS Curriculum
timeFrame: Period 2 (18 months)
measure: Change in Residents' Questionnaire Scores Regarding Their Beliefs From Pre- to Post-PACTS Curriculum
timeFrame: Period 2 (18 months)
measure: Objective Structured Clinical Examination Scores
timeFrame: Period 2 (18 months)
Secondary outcomes:
measure: Patients' Self-reported Satisfaction Scores
timeFrame: Period 2 (18 months)
measure: Median Hospital Length of Stay for Patient Participants
timeFrame: Period 2 (18 months)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Brigham and Women's Hospital
name: Adil Haider, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Douglas Smink, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.