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NCT03576495: PACTS

The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial

Completed NA Results posted Last updated 7 June 2024
What this trial tests

NA trial testing PACTS curriculum in Resident Knowledge and Attitudes Regarding Cross-cultural Care in 2,901 participants. Completed in 30 June 2022.

Timeline
1 July 2019
Primary endpoint
30 June 2022
30 June 2022

Quick facts

Lead sponsorBrigham and Women's Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposehealth services research
Enrollment2,901
Start date1 July 2019
Primary completion30 June 2022
Estimated completion30 June 2022
Sites8 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brigham and Women's Hospital

Who can join

18 and older, any sex, with Resident Knowledge and Attitudes Regarding Cross-cultural Care or Interpersonal and Communication Skills in Patient-clinician Encounters. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Residents' Questionnaire Scores Measuring Knowledge From Pre- to Post-PACTS Curriculum Primary · Period 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 Interventi

GroupValue95% CI
Early Intervention Group74.3± 8.96
Delayed Intervention Group71.7± 13.39
Change in Residents' Cross Cultural Care Survey Scores From Pre- to Post-PACTS Curriculum Primary · Period 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, thos

GroupValue95% CI
Early Intervention88.2
Delayed Intervention Group88.2
Change in Residents' Questionnaire Scores Regarding Self-Assessed Skills From Pre- to Post-PACTS Curriculum Primary · Period 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 proportio

GroupValue95% CI
Early Intervention Group85.0
Delayed Intervention Group84.1
Change in Residents' Questionnaire Scores Regarding Their Beliefs From Pre- to Post-PACTS Curriculum Primary · Period 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: stro

GroupValue95% CI
Early Intervention / Retention Group92.4
Delayed Intervention Group89.9
Objective Structured Clinical Examination Scores Primary · Period 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.

Limited English Proficiency/Informed Consent Period 2
GroupValue95% CI
Early Intervention Group (Residents)60.9
Delayed Intervention Group (Residents)63.1
Trust/Pain Period 2
GroupValue95% CI
Early Intervention Group (Residents)58.6
Delayed Intervention Group (Residents)64.8
Patients' Self-reported Satisfaction Scores Secondary · Period 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."

Trust Period 2
GroupValue95% CI
Early Intervention Group72.06
Delayed Intervention Group75.25
Limited English Proficiency Period 2
GroupValue95% CI
Early Intervention Group53.48
Delayed Intervention Group51.56
Consent Period 2
GroupValue95% CI
Early Intervention Group77.94
Delayed Intervention Group82.7
Pain Period 2
GroupValue95% CI
Early Intervention Group81.0
Delayed Intervention Group81.19
Median Hospital Length of Stay for Patient Participants Secondary · Period 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 medi

GroupValue95% CI
Early Intervention Group (Patients)8.855.35 – 12.35
Delayed Intervention Group (Patients)14.168.66 – 19.66

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Perceived Discrimination Among Surgical Residents at Academic Medical Centers.
    Khubchandani JA, Atkinson RB, Ortega G, Reidy E, et al · · 2022 · cited 16× · PMID 34942508 · DOI 10.1016/j.jss.2021.10.029
  2. Changing Surgical Culture Through Surgical Education: Introduction to the PACTS Trial.
    Allar BG, Ortega G, Chun MBJ, Rodriguez JGZ, et al · · 2024 · cited 4× · PMID 38142149 · DOI 10.1016/j.jsurg.2023.11.018
  3. A Randomized Crossover Trial Evaluating the Impact of Cultural Dexterity Training on Surgical Residents' Knowledge, Cross-Cultural Care, Skills, and Beliefs: The Provider Awareness and Cultural Dexterity Training for Surgeons (PACTS) Trial.
    Smink DS, Ortega G, Dacier BM, Petrusa ER, et al · · 2024 · cited 2× · PMID 38921829 · DOI 10.1097/sla.0000000000006408

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03576495.

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