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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03576495
Recruitment Status : Active, not recruiting
First Posted : July 3, 2018
Last Update Posted : March 19, 2021
Sponsor:
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

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

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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

Resource links provided by the National Library of Medicine


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.





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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576495


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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