HypertensionCONSULT-BPNCT03375918
COmmuNity-engaged SimULation Training for Blood Pressure Control
A study testing CONSULT-BP Educational Intervention in people with Hypertension, run by University of Massachusetts, Worcester at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- CONSULT-BP Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Aug 2018to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- English-speaking
- Non-White racial/ethnic minority or Medicaid recipient (regardless of race/ethnicity)
- Hypertension identified in the EMR
Who cannot join
- For Patient Participants -
- Enrolled in hospice.
- Pregnancy, dementia, schizophrenia, bipolar illness, or other serious medical co-morbidity that would interfere with hypertension self-control
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Barre Family Health Center
Barre, Massachusetts, 01005
Tri River Family Health Center
Uxbridge, Massachusetts, 01569
UMass Memorial Hahnemann Family Health Center
Worcester, Massachusetts, 01605
UMass Memorial Medical Center -- Benedict Building
Worcester, Massachusetts, 01605
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- CONSULT-BP Educational Intervention
- Keywords
- Healthcare disparities, Racial Bias
- Medical subject headings
- Hypertension, Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONSULT-BP Educational InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CONSULT-BP Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Systolic and diastolic blood pressure of patients treated by the participating clinician trainees as reported in the Electronic Medical Record.
Measured: 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
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.
Measured: During CONSULT-BP session 2 clinician training intervention (simulated standardized patient encounter)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start13 Aug 2018
- Primary completion31 Dec 2022
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jennifer Tjia, University of Massachusetts, Worcester
- Investigators
- Jennifer Tjia, MD, MSCE, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375918
- Sponsor's protocol ID
- H00012160
- Other IDs
- 1R01MD011532
- Acronym
- CONSULT-BP
- Status last verified
- Aug 2025
- First submitted
- 12 Dec 2017
- Last updated
- 19 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual level participant data includes protected health information. There is no plan to share these data with other researchers.
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.
PubMed 37324051Tjia 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.
PubMed 33592827Calista 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.
PubMed 37462563
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmmuNity-engaged SimULation Training for Blood Pressure Control
- ClinicalTrials.gov ID
- NCT03375918
- Acronym / sponsor ID
- CONSULT-BP / H00012160
- Conditions
- Hypertension
- Keywords
- Healthcare disparities, Racial Bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Posted 19 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthcare Trainees | Other | Other: CONSULT-BP Educational InterventionTrainees were assigned to receive Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- English-speaking
- Non-White racial/ethnic minority or Medicaid recipient (regardless of race/ethnicity)
Key exclusion criteria (3 listed)
- For Patient Participants -
- Enrolled in hospice.
- Pregnancy, dementia, schizophrenia, bipolar illness, or other serious medical co-morbidity that would interfere with hypertension self-control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONSULT-BP Educational InterventionCONSULT-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. | Other | Healthcare Trainees |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37324051Tjia 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.
- Background: PubMed 33592827Tjia 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.
- Background: PubMed 37462563Calista 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.
- Individual participant dataSharing planned: No. Individual level participant data includes protected health information. There is no plan to share these data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Tjia, MD, MSCE principal investigator
UMass Medical School
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONSULT-BP Educational Intervention in people with Hypertension, run by University of Massachusetts, Worcester at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: Control period is 6 months before the intervention and intervention period is up to 6 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03375918, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.