An interventional study of CONSULT-BP Educational Intervention in Hypertension, sponsored by University of Massachusetts, Worcester. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Health services research
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.
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.
For Healthcare Trainees -
Inclusion Criteria:
Exclusion Criteria: 1. All 1st year trainees
For Patient Participants -
Inclusion Criteria:
Exclusion Criteria:
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
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.
Blood Pressure
Systolic and diastolic blood pressure of patients treated by the participating clinician trainees as reported in the Electronic Medical Record.
Time frame: Control period is 6 months before the intervention and intervention period is up to 6 months after the intervention
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.
Time frame: During CONSULT-BP session 2 clinician training intervention (simulated standardized patient encounter)
Within each academic year, we aimed to randomize training times to 1 of 5 start dates using a stepped wedge design. However, this design was not feasible beyond the first year of our study because of the COVID emergency.
| Milestone | Year 1: Start Time 1 | Year 1: Start Time 2 | Year 1: Start Time 3 | Year 1: Start Time 4 | Year 1: Start Time 5 | Year 2: Cohort 1 | Year 3: Cohort 2 | Year 4: Cohort 3 |
|---|---|---|---|---|---|---|---|---|
| Started | 600 | 106 | 527 | 215 | 264 | 336 | 256 | 409 |
| Control patients | 54 | 40 | 201 | 104 | 125 | 150 | 80 | 190 |
| Intervention patients | 534 | 60 | 314 | 98 | 135 | 159 | 155 | 196 |
| Trainees | 12 | 6 | 12 | 13 | 4 | 27 | 21 | 23 |
| Completed | 600 | 106 | 527 | 215 | 264 | 336 | 256 | 409 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Systolic and diastolic blood pressure of patients treated by the participating clinician trainees as reported in the Electronic Medical Record.
| mm Hg | Patients - Pre CONSULT-BP Intervention | Patients - Post-Intervention |
|---|---|---|
| Systolic Blood Pressure | 137.6 ± 18.6 | 136.4 ± 18.6 |
| Diastolic BloodPressure | 82.1 ± 11.1 | 81.8 ± 10.8 |
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.
| score on a scale | Healthcare Trainees |
|---|---|
| RELATE Checklist, a Standardized Patient Rating Scale for Bias-Mitigating and Patient-Centered Communication | 32.7 ± 5.0 |
Collected over 6 months after the intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthcare Trainees | 0/118 (0%) | 0/118 (0%) | 0/118 (0%) |
| Patients - Control Arm | 0/944 (0%) | 0/944 (0%) | 0/944 (0%) |
| Patients - Intervention Arm | 0/1,651 (0%) | 0/1,651 (0%) | 0/1,651 (0%) |
Baseline information on Healthcare Trainees, Patients--Control Arm and Patients--Intervention Arm are aggregated from all cohorts within each population.
| Age, Continuous(years) | Healthcare Trainees | Patients - Control Arm | Patients - Intervention Arm | Total |
|---|---|---|---|---|
| Mean | 30.7 ± 2.75 | 54.8 ± 13.6 | 54.8 ± 13.2 | 54.8 ± 13 |
| Sex: Female, Male(Participants) | Healthcare Trainees | Patients - Control Arm | Patients - Intervention Arm | Total |
|---|---|---|---|---|
| Female | 58 | 486 | 894 | 1438 |
| Male | 60 | 458 | 757 | 1275 |
| Ethnicity (NIH/OMB)(Participants) | Healthcare Trainees | Patients - Control Arm | Patients - Intervention Arm | Total |
|---|---|---|---|---|
| Hispanic or Latino | 9 | 135 | 217 | 361 |
| Not Hispanic or Latino | 53 | 800 | 1425 | 2278 |
| Unknown or Not Reported | 56 | 9 | 9 | 74 |
| Race (NIH/OMB)(Participants) | Healthcare Trainees | Patients - Control Arm | Patients - Intervention Arm | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 22 | 81 | 117 | 220 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 214 | 364 | 582 |
| White | 39 | 215 | 383 | 637 |
| More than one race | 1 | 425 | 778 | 1204 |
| Unknown or Not Reported | 52 | 9 | 9 | 70 |
| Region of Enrollment(Participants) | Healthcare Trainees | Patients - Control Arm | Patients - Intervention Arm | Total |
|---|---|---|---|---|
| United States | 118 | 944 | 1651 | 2713 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual level participant data includes protected health information. There is no plan to share these data with other researchers.
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University of Massachusetts, Worcester