- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03375918
COmmuNity-engaged SimULation Training for Blood Pressure Control (CONSULT-BP)
August 29, 2025 updated by: Jennifer Tjia, University of Massachusetts, Worcester
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
CONSULT-BP is an intervention to test a theory-based, 'awareness, exposure and skill-building' approach applied in the safety of a simulation-based learning center, to improve providers' interaction skills with minority and poor patients.
The study included community-based participatory research input to develop and implement CONSULT-BP in an academic medical center with a large, safety-net health system which serves minority and poor population.
Study Type
Interventional
Enrollment (Actual)
118
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Barre, Massachusetts, United States, 01005
- Barre Family Health Center
-
Uxbridge, Massachusetts, United States, 01569
- Tri River Family Health Center
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Worcester, Massachusetts, United States, 01605
- UMass Memorial Hahnemann Family Health Center
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Worcester, Massachusetts, United States, 01605
- UMass Memorial Medical Center -- Benedict Building
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
For Healthcare Trainees -
Inclusion Criteria:
- Practice at a clinical site supported by an EMR to allow clinical data collection for outcome measurement
- 15-week clinical look-back period
- No prior completion of the CONSULT-BP intervention
Exclusion Criteria: 1. All 1st year trainees
For Patient Participants -
Inclusion Criteria:
- English-speaking
- Non-White racial/ethnic minority or Medicaid recipient (regardless of race/ethnicity)
- Hypertension identified in the EMR
Exclusion Criteria:
- Enrolled in hospice.
- Pregnancy, dementia, schizophrenia, bipolar illness, or other serious medical co-morbidity that would interfere with hypertension self-control
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthcare Trainees
Trainees were assigned to receive Other: CONSULT-BP Educational Intervention.
Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure
Time Frame: Control period is 6 months before the intervention and intervention period is up to 6 months after the intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RELATE Checklist, a Standardized Patient Rating Scale for Bias-Mitigating and Patient-Centered Communication
Time Frame: During CONSULT-BP session 2 clinician training intervention (simulated standardized patient encounter)
|
The RELATE (Respect, Empathize, Listen, Ask, Talk, Engage) is a 19-item checklist completed by an informant group of "standardized" patients during a simulated standardized patient encounter to evaluate interaction with the participating clinicians.
The RELATE checklist contains 4 factors: Respect (4 items), Empathetic Listening (5 items); Ask and Talk (Inquiry, 6 items), and Engagement in Partnership (4 items).
The checklist scores are from 0 to 38, with higher scores reflecting better communication from the perspective of the "standardized" patient.
|
During CONSULT-BP session 2 clinician training intervention (simulated standardized patient encounter)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer Tjia, MD, MSCE, UMass Medical School
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 13, 2018
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
January 31, 2024
Study Registration Dates
First Submitted
December 12, 2017
First Submitted That Met QC Criteria
December 14, 2017
First Posted (Actual)
December 18, 2017
Study Record Updates
Last Update Posted (Estimated)
September 19, 2025
Last Update Submitted That Met QC Criteria
August 29, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H00012160
- 1R01MD011532 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual level participant data includes protected health information.
There is no plan to share these data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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