COmmuNity-engaged SimULation Training for Blood Pressure Control

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT03375918
• Lead Sponsor: University of Massachusetts, Worcester

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.

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 Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-18
• Study Start: 2018-08-13
• Primary Completion: 2022-12-31
• Results First Submitted: 2024-01-18
• Study Completion: 2024-01-31
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Results First Posted: 2025-09-19
• Last Update Posted: 2025-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Blood Pressure	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.

Secondary Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

Locations (4)

Barre Family Health Center; 🇺🇸 Barre, Massachusetts, United States

Tri River Family Health Center; 🇺🇸 Uxbridge, Massachusetts, United States

UMass Memorial Hahnemann Family Health Center; 🇺🇸 Worcester, Massachusetts, United States

UMass Memorial Medical Center -- Benedict Building; 🇺🇸 Worcester, Massachusetts, United States