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

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
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Hahnemann Family Health Center
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center -- Benedict Building

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:

  1. Practice at a clinical site supported by an EMR to allow clinical data collection for outcome measurement
  2. 15-week clinical look-back period
  3. No prior completion of the CONSULT-BP intervention

Exclusion Criteria: 1. All 1st year trainees

For Patient Participants -

Inclusion Criteria:

  1. English-speaking
  2. Non-White racial/ethnic minority or Medicaid recipient (regardless of race/ethnicity)
  3. Hypertension identified in the EMR

Exclusion Criteria:

  1. Enrolled in hospice.
  2. 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.

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

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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