Hypertension
Conditions
Keywords
Healthcare disparities, Racial Bias
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.
Interventions
OTHERCONSULT-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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Massachusetts, Worcester
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
To maintain clinical staff services in the hospital, we were not able to maintain the cluster randomization of trainees. We aimed to enroll cohorts of trainees over a 3-year period, with each academic year constituting an intervention cycle, with 3 cycles of implementation corresponding to 3 sequential academic years. Due to COVID, we extended enrollment to a 4-year period. Please note - only trainee participants were considered enrolled. Patient participants were not considered 'enrolled'.
Participants by arm
| Arm | Count |
|---|---|
| Healthcare Trainees Healthcare trainee clusters assigned to 1 of 5 start dates training times for Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period. | 118 |
| Patients - Control Arm Patients treated by healthcare trainees within the control period | 944 |
| Patients - Intervention Arm Patients treated by healthcare trainees within the intervention period | 1,651 |
| Total | 2,713 |
Baseline characteristics
| Characteristic | Healthcare Trainees | Total | Patients - Intervention Arm | Patients - Control Arm |
|---|---|---|---|---|
| Age, Continuous | 30.7 years STANDARD_DEVIATION 2.75 | 54.8 years STANDARD_DEVIATION 13 | 54.8 years STANDARD_DEVIATION 13.2 | 54.8 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 361 Participants | 217 Participants | 135 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 2278 Participants | 1425 Participants | 800 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 56 Participants | 74 Participants | 9 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 22 Participants | 220 Participants | 117 Participants | 81 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 582 Participants | 364 Participants | 214 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1204 Participants | 778 Participants | 425 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 52 Participants | 70 Participants | 9 Participants | 9 Participants |
| Race (NIH/OMB) White | 39 Participants | 637 Participants | 383 Participants | 215 Participants |
| Region of Enrollment United States | 118 Participants | 2713 Participants | 1651 Participants | 944 Participants |
| Sex: Female, Male Female | 58 Participants | 1438 Participants | 894 Participants | 486 Participants |
| Sex: Female, Male Male | 60 Participants | 1275 Participants | 757 Participants | 458 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 944 | 0 / 1,651 |
| other Total, other adverse events | 0 / 118 | 0 / 944 | 0 / 1,651 |
| serious Total, serious adverse events | 0 / 118 | 0 / 944 | 0 / 1,651 |
Outcome results
Primary
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
Population: Blood pressure data was obtained from electronic medical records of 944 patients during the control period and 1,651 period patients during the intervention period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients - Pre CONSULT-BP Intervention | Blood Pressure | Systolic Blood Pressure | 137.6 mm Hg | Standard Deviation 18.6 |
| Patients - Pre CONSULT-BP Intervention | Blood Pressure | Diastolic BloodPressure | 82.1 mm Hg | Standard Deviation 11.1 |
| Patients - Post-Intervention | Blood Pressure | Diastolic BloodPressure | 81.8 mm Hg | Standard Deviation 10.8 |
| Patients - Post-Intervention | Blood Pressure | Systolic Blood Pressure | 136.4 mm Hg | Standard Deviation 18.6 |
Secondary
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)
Population: RELATE scores were obtained from standardized patients (or mock patients) during interaction with the Clinician Trainees.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients - Pre CONSULT-BP Intervention | RELATE Checklist, a Standardized Patient Rating Scale for Bias-Mitigating and Patient-Centered Communication | 32.7 score on a scale | Standard Deviation 5 |