COmmuNity-engaged SimULation Training for Blood Pressure Control

NCT03375918 | Completed Results

• 2 other identifiers: H000121601R01MD011532
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of CONSULT-BP is to train early-stage healthcare providers, including residents and nurse practitioner (NP) students, to mitigate providers' bias, improve communication skills, and enhance providers' ability to develop authentic and meaningful therapeutic alliances with patients. The study setting is an academic safety net hospital that serves a large non-White and poor population. The Investigators hypothesize that patients' outcomes (blood pressure levels) will be lower after the training intervention compared with before training (control) periods.

Conditions

Hypertension

Keywords

Healthcare disparities; Racial Bias

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Systolic and diastolic blood pressure of patients treated by the participating clinician trainees as reported in the Electronic Medical Record.

  Control period is 6 months before the intervention and intervention period is up to 6 months after the intervention

Secondary Outcomes (1)

• RELATE Checklist, a Standardized Patient Rating Scale for Bias-Mitigating and Patient-Centered Communication

  During CONSULT-BP session 2 clinician training intervention (simulated standardized patient encounter)

Study Arms (1)

Healthcare Trainees

OTHER

Trainees were assigned to receive Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.

Other: CONSULT-BP Educational Intervention

Interventions

CONSULT-BP Educational Intervention OTHER

CONSULT-BP is a two sessions training provided to healthcare trainees over a 5-week period. The first session focused on (1) didactic overview of healthcare disparities, social drivers of health, implicit bias and systemic racism and (2) interactive discussions and patient storytelling videos to raise awareness of the bi-directional role of racial and ethnic identity among clinicians and patients. The second session focused on skill building and included (1) bias mitigation strategies based on the RELATE bias mitigation tool and (2) skill practice using 2 standardized patient simulated clinical encounters focusing on hypertension management challenges.

Healthcare Trainees

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Practice at a clinical site supported by an EMR to allow clinical data collection for outcome measurement
• week clinical look-back period
• No prior completion of the CONSULT-BP intervention

You may not qualify if:

• For Patient Participants -
• English-speaking
• Non-White racial/ethnic minority or Medicaid recipient (regardless of race/ethnicity)
• Hypertension identified in the EMR
• Enrolled in hospice.
• Pregnancy, dementia, schizophrenia, bipolar illness, or other serious medical co-morbidity that would interfere with hypertension self-control

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (4)

Barre Family Health Center

Barre, Massachusetts, 01005, United States

Location

Tri River Family Health Center

Uxbridge, Massachusetts, 01569, United States

Location

UMass Memorial Hahnemann Family Health Center

Worcester, Massachusetts, 01605, United States

Location

UMass Memorial Medical Center -- Benedict Building

Worcester, Massachusetts, 01605, United States

Location

Related Publications (3)

• Tjia J, Pugnaire M, Calista J, Eisdorfer E, Hale J, Terrien J, Valdman O, Potts S, Garcia M, Yazdani M, Puerto G, Okero M, Duodu V, Sabin J. Using Simulation-Based Learning with Standardized Patients (SP) in an Implicit Bias Mitigation Clinician Training Program. J Med Educ Curric Dev. 2023 Jun 5;10:23821205231175033. doi: 10.1177/23821205231175033. eCollection 2023 Jan-Dec.

  PMID: 37324051 BACKGROUND

• Tjia J, Pugnaire M, Calista J, Esparza N, Valdman O, Garcia M, Yazdani M, Hale J, Terrien J, Eisdorfer E, Zolezzi-Wyndham V, Chiriboga G, Rappaport L, Puerto G, Dykhouse E, Potts S, Sifuentes AF, Stanhope S, Allison J, Duodo V, Sabin J. COmmuNity-engaged SimULation Training for Blood Pressure Control (CONSULT-BP): A study protocol. Medicine (Baltimore). 2021 Feb 5;100(5):e23680. doi: 10.1097/MD.0000000000023680.

  PMID: 33592827 BACKGROUND

• Calista J, Esparza N, Fernandez J, Beltran A, Bradshaw J, Casseres A, Duodu S, Duodu V, Fordjour C, Kuffour B, Mensah L, Negron-Cruz L, Pietri C, Pridgen C, Puerto G, Tessler LA, Tucci S, Wood K, Wright S, Zinkus P, Tjia J. Perspectives of Community Partners Involved in an Academic Training to Address Clinicians' Implicit Bias. Prog Community Health Partnersh. 2023;17(2):347-351. doi: 10.1353/cpr.2023.a900215.

  PMID: 37462563 BACKGROUND

MeSH Terms

Conditions

Hypertension; Racism

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Prejudice; Social Behavior; Behavior; Social Discrimination

Results Point of Contact

• Title: Jennifer Tjia
• Organization: UMass Chan Medical School

jennifer.tjia@umassmed.edu

774-455-3538

Study Officials

• Jennifer Tjia, MD, MSCE

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The primary outcome is blood pressure (BP) change as recorded in the electronic medical record (EMR) of racial/ethnic minority patients and Medicaid recipients of any race/ethnicity with controlled and uncontrolled hypertension. Secondary outcomes are standardized patient assessments of clinical trainee communication skills. Standardized patient participants are masked to the intervention status of their provider trainees.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Population and Quantitative Health Sciences

Model Details: Enrolled 4 sequential cohorts of clinical trainees \[stratified by specialty (internal medicine (IM), family medicine (FM)\] were to be assigned to 1 of 5 start dates within each cohort year. During the global pandemic, randomized assignment within each year was not possible due to clinical needs of the hospitals, which means that the intervention was a pre-post intervention study. Clinical outcomes will be assessed at the patient level.

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: August 13, 2018
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2024
• Last Updated: September 19, 2025
• Results First Posted: September 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)