Trial Outcomes & Findings for COmmuNity-engaged SimULation Training for Blood Pressure Control (NCT NCT03375918)
NCT ID: NCT03375918
Last Updated: 2025-09-19
Results Overview
Systolic and diastolic blood pressure of patients treated by the participating clinician trainees as reported in the Electronic Medical Record.
COMPLETED
NA
118 participants
Control period is 6 months before the intervention and intervention period is up to 6 months after the intervention
2025-09-19
Participant Flow
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.
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'.
Participant milestones
| Measure |
Year 1: Start Time 1
1 of 5 trainee groups to start the intervention at time point 1.
|
Year 1: Start Time 2
1 of 5 trainee groups to start the intervention at time point 2.
|
Year 1: Start Time 3
1 of 5 trainee groups to start the intervention at time point 3.
|
Year 1: Start Time 4
1 of 5 trainee groups to start the intervention at time point 4.
|
Year 1: Start Time 5
1 of 5 trainee groups to start the intervention at time point 5.
|
Year 2: Cohort 1
Trainees in year 2
Outcomes measured at level of patients nested within trainee Control period patient BP measures are pre-intervention Intervention period patient BP measures are post-intervention
|
Year 3: Cohort 2
Trainees in year 3
Outcomes measured at level of patients nested within trainee Control period patient BP measures are pre-intervention Intervention period patient BP measures are post-intervention
|
Year 4: Cohort 3
Trainees in year 4
Outcomes measured at level of patients nested within trainee Control period patient BP measures are pre-intervention Intervention period patient BP measures are post-intervention
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
600
|
106
|
527
|
215
|
264
|
336
|
256
|
409
|
|
Overall Study
Control Patients
|
54
|
40
|
201
|
104
|
125
|
150
|
80
|
190
|
|
Overall Study
Intervention Patients
|
534
|
60
|
314
|
98
|
135
|
159
|
155
|
196
|
|
Overall Study
Trainees
|
12
|
6
|
12
|
13
|
4
|
27
|
21
|
23
|
|
Overall Study
COMPLETED
|
600
|
106
|
527
|
215
|
264
|
336
|
256
|
409
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COmmuNity-engaged SimULation Training for Blood Pressure Control
Baseline characteristics by cohort
| Measure |
Healthcare Trainees
n=118 Participants
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.
|
Patients - Control Arm
n=944 Participants
Patients treated by healthcare trainees within the control period
|
Patients - Intervention Arm
n=1651 Participants
Patients treated by healthcare trainees within the intervention period
|
Total
n=2713 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 2.75 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
486 Participants
n=7 Participants
|
894 Participants
n=5 Participants
|
1438 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
458 Participants
n=7 Participants
|
757 Participants
n=5 Participants
|
1275 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
361 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
800 Participants
n=7 Participants
|
1425 Participants
n=5 Participants
|
2278 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
56 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
582 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
637 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
425 Participants
n=7 Participants
|
778 Participants
n=5 Participants
|
1204 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
52 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
118 Participants
n=5 Participants
|
944 Participants
n=7 Participants
|
1651 Participants
n=5 Participants
|
2713 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Control period is 6 months before the intervention and intervention period is up to 6 months after the interventionPopulation: 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.
Systolic and diastolic blood pressure of patients treated by the participating clinician trainees as reported in the Electronic Medical Record.
Outcome measures
| Measure |
Patients - Pre CONSULT-BP Intervention
n=944 Participants
Patient BPs from prior to the CONSULT-BP Intervention taken from the Electronic Medical Record.
|
Patients - Post-Intervention
n=1651 Participants
Patient BPs from after the CONSULT-BP Intervention taken from the Electronic Medical Record.
|
|---|---|---|
|
Blood Pressure
Systolic Blood Pressure
|
137.6 mm Hg
Standard Deviation 18.6
|
136.4 mm Hg
Standard Deviation 18.6
|
|
Blood Pressure
Diastolic BloodPressure
|
82.1 mm Hg
Standard Deviation 11.1
|
81.8 mm Hg
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Patients - Pre CONSULT-BP Intervention
n=118 Participants
Patient BPs from prior to the CONSULT-BP Intervention taken from the Electronic Medical Record.
|
Patients - Post-Intervention
Patient BPs from after the CONSULT-BP Intervention taken from the Electronic Medical Record.
|
|---|---|---|
|
RELATE Checklist, a Standardized Patient Rating Scale for Bias-Mitigating and Patient-Centered Communication
|
32.7 score on a scale
Standard Deviation 5.0
|
—
|
Adverse Events
Healthcare Trainees
Patients - Control Arm
Patients - Intervention Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place