The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial (PACTS)

• ClinicalTrials.gov Identifier: NCT03576495
• Recruitment Status: Active, not recruiting
• First Posted: July 3, 2018
• Last Update Posted: March 19, 2021
• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Massachusetts General Hospital; Beth Israel Deaconess Medical Center; Howard University; Johns Hopkins University; Brown University; Eastern Virginia Medical School; Washington University School of Medicine
• Information provided by (Responsible Party): Adil Haider, Brigham and Women's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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	Other: PACTS curriculum	Not Applicable

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 to evaluate 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, team-based learning. It consists of e-learning modules, interactive sessions in which residents will apply concepts from the e-learning modules to roleplay 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

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 Pain Treatment Satisfaction Scale (PTSS).

Clinical surgical outcomes obtained from the NSQIP database will be assessed for each patient participant before and after the PACTS curriculum is implemented to measure individual outcomes such as length of stay, postoperative complications, unplanned reoperations, and 30-day morbidity/mortality.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2800 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.
• Masking: None (Open Label)
• Masking Description: Resident program directors and research staff will not be blinded to the implementation of curriculum
• Primary Purpose: Health Services Research
• Official Title: The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial
• Actual Study Start Date: July 1, 2019
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: June 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Early Intervention / Retention Group; The investigators will assess the residents' knowledge, attitudes, and skills prior to and after the PACTS curriculum administration at half the sites (Early Intervention/Retention Group). Follow-up testing will be conducted after one year to evaluate learner retention. Further, the investigators will test post-exposure effect retention in the Early Intervention Group at the end of year 2.	Other: 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.
Active Comparator: Delayed Intervention Group; The investigators will conduct baseline testing prior to the standard residency curriculum, and administer 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.	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in residents' questionnaire scores from pre- to post-PACTS curriculum [ Time Frame: Year 2 and Year 3 ]
   The effect of PACTS curriculum on surgical residents' questionnaire scores measuring knowledge and attitudes about caring for culturally diverse patients
2. Objective Structured Clinical Examination scores [ Time Frame: Year 2 and year 3 ]
   Standardized Patient observers will evaluate surgical residents on multiple dimensions of cultural dexterity and communication skills using Likert-type scales.

Secondary Outcome Measures :

1. Patients' self-reported satisfaction scores [ Time Frame: Year 2 and Year 3 ]
   An adapted version of the CAHPS Pain Treatment Satisfaction Scale will be used to assess patients' (1) satisfaction with pain management, (2) satisfaction with communication including specific measures for LEP, (3) trust, and (4) comprehension of informed consent.
2. Patients' clinical outcomes: length of stay [ Time Frame: Year 2 and 3 ]
   NSQIP metrics for each patient participant capturing length of stay in days
3. Patients' clinical outcomes: surgical complications [ Time Frame: Year 2 and 3 ]
   NSQIP metrics for each patient participant capturing complications experienced as a result of surgical procedure
4. Patients' clinical outcomes: 30-day morbidity, mortality, and complications [ Time Frame: Year 2 and 3 ]
   NSQIP metrics for each patient participant capturing 30-day quality measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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, and 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, and 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.

Contacts and Locations

Locations

United States, District of Columbia

Howard University Hospital

Washington, District of Columbia, United States, 20059

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

United States, Missouri

Washington University in St. Louis

Saint Louis, Missouri, United States, 63130

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02905

United States, Virginia

Eastern Virginia Medical School

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Brigham and Women's Hospital

National Institute on Minority Health and Health Disparities (NIMHD)

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Howard University

Johns Hopkins University

Brown University

Eastern Virginia Medical School

Washington University School of Medicine

Investigators

• Principal Investigator: Adil Haider, MD, MPH; Brigham and Women's Hospital
• Principal Investigator: Douglas Smink, MD, MPH; Brigham and Women's Hospital

More Information

Publications:

Haider AH, Weygandt PL, Bentley JM, Monn MF, Rehman KA, Zarzaur BL, Crandall ML, Cornwell EE, Cooper LA. Disparities in trauma care and outcomes in the United States: a systematic review and meta-analysis. J Trauma Acute Care Surg. 2013 May;74(5):1195-205. doi: 10.1097/TA.0b013e31828c331d. Review.

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. Review.

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. Review.

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.

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.

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.

Horvat L, Horey D, Romios P, Kis-Rigo J. Cultural competence education for health professionals. Cochrane Database Syst Rev. 2014 May 5;(5):CD009405. doi: 10.1002/14651858.CD009405.pub2. Review.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Adil Haider, Kessler Director, Center for Surgery and Public Health, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT03576495
• Other Study ID Numbers: 2018P001237; 1R01MD011685-01A1 ( U.S. NIH Grant/Contract )
• First Posted: July 3, 2018
• Last Update Posted: March 19, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adil Haider, Brigham and Women's Hospital:

Medical education; Patient-reported Satisfaction; Patient-reported outcomes; Cultural dexterity; Cross cultural care; Resident physician education