PACTS: The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03576495

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH), Massachusetts General Hospital (Other), Beth Israel Deaconess Medical Center (Other), Howard University (Other), Johns Hopkins University (Other), Brown University (Other), Eastern Virginia Medical School (Other), Washington University School of Medicine (Other)

2,800

Enrollment

Locations

Arms

Anticipated Duration (Months)

350

Patients Per Site

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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.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 :

Jul 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jun 1, 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.

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

Outcome Measures

Primary Outcome Measures

Change in residents' questionnaire scores from pre- to post-PACTS curriculum [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
Objective Structured Clinical Examination scores [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

Patients' self-reported satisfaction scores [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.
Patients' clinical outcomes: length of stay [Year 2 and 3]
NSQIP metrics for each patient participant capturing length of stay in days
Patients' clinical outcomes: surgical complications [Year 2 and 3]
NSQIP metrics for each patient participant capturing complications experienced as a result of surgical procedure
Patients' clinical outcomes: 30-day morbidity, mortality, and complications [Year 2 and 3]
NSQIP metrics for each patient participant capturing 30-day quality measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

*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

	Site	City	State	Country	Postal Code
1	Howard University Hospital	Washington	District of Columbia	United States	20059
2	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
5	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
6	Washington University in St. Louis	Saint Louis	Missouri	United States	63130
7	Rhode Island Hospital	Providence	Rhode Island	United States	02905
8	Eastern Virginia Medical School	Norfolk	Virginia	United States	23507