COmmuNity-engaged SimULation Training for Blood Pressure Control

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Blood Pressure (BP) Visit Intensification Study

NCT02164331

Blood Pressure Hypertension

COMPLETED NA

MI-BP: mHealth to Improve Blood Pressure Control

NCT02955537

Hypertension

COMPLETED NA

App-based Remote Blood Pressure Monitoring

NCT05595629

Gestational Hypertension Preeclampsia Chronic Hypertension Complicating Pregnancy

COMPLETED NA

Personalized Physician Learning to Improve Hypertension Care

NCT00903071

Hypertension

COMPLETED NA

Clinician Counseling and Cultural Competency to Improve Hypertension Control and Therapy Adherence

NCT00201149

Cardiovascular Diseases Heart Diseases Hypertension

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

The primary outcome is blood pressure (BP) change as recorded in the electronic medical record (EMR) of racial/ethnic minority patients and Medicaid recipients of any race/ethnicity with controlled and uncontrolled hypertension. Secondary outcomes are standardized patient assessments of clinical trainee communication skills. Standardized patient participants are masked to the intervention status of their provider trainees.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

CONSULT-BP Educational Intervention

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Exclusion Criteria

For Patient Participants -

1. Enrolled in hospice.
2. Pregnancy, dementia, schizophrenia, bipolar illness, or other serious medical co-morbidity that would interfere with hypertension self-control

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes