Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MD011532 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthcare Trainees | Other | Trainees were assigned to receive Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONSULT-BP Educational Intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Systolic and diastolic blood pressure of patients treated by the participating clinician trainees as reported in the Electronic Medical Record. | Control period is 6 months before the intervention and intervention period is up to 6 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
For Healthcare Trainees -
Inclusion Criteria:
Exclusion Criteria: 1. All 1st year trainees
For Patient Participants -
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Tjia, MD, MSCE | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barre Family Health Center | Barre | Massachusetts | 01005 | United States | ||
| Tri River Family Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37324051 | Background | Tjia J, Pugnaire M, Calista J, Eisdorfer E, Hale J, Terrien J, Valdman O, Potts S, Garcia M, Yazdani M, Puerto G, Okero M, Duodu V, Sabin J. Using Simulation-Based Learning with Standardized Patients (SP) in an Implicit Bias Mitigation Clinician Training Program. J Med Educ Curric Dev. 2023 Jun 5;10:23821205231175033. doi: 10.1177/23821205231175033. eCollection 2023 Jan-Dec. | |
| 33592827 | Background | Tjia J, Pugnaire M, Calista J, Esparza N, Valdman O, Garcia M, Yazdani M, Hale J, Terrien J, Eisdorfer E, Zolezzi-Wyndham V, Chiriboga G, Rappaport L, Puerto G, Dykhouse E, Potts S, Sifuentes AF, Stanhope S, Allison J, Duodo V, Sabin J. COmmuNity-engaged SimULation Training for Blood Pressure Control (CONSULT-BP): A study protocol. Medicine (Baltimore). 2021 Feb 5;100(5):e23680. doi: 10.1097/MD.0000000000023680. |
Not provided
Not provided
Individual level participant data includes protected health information. There is no plan to share these data with other researchers.
Not provided
Not provided
Not provided
Not provided
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'.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Year 1: Start Time 1 | 1 of 5 trainee groups to start the intervention at time point 1. |
| FG001 | Year 1: Start Time 2 | 1 of 5 trainee groups to start the intervention at time point 2. |
| FG002 | Year 1: Start Time 3 | 1 of 5 trainee groups to start the intervention at time point 3. |
| FG003 | Year 1: Start Time 4 | 1 of 5 trainee groups to start the intervention at time point 4. |
| FG004 | Year 1: Start Time 5 | 1 of 5 trainee groups to start the intervention at time point 5. |
| FG005 | 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 |
| FG006 | 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 |
| FG007 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline information on Healthcare Trainees, Patients--Control Arm and Patients--Intervention Arm are aggregated from all cohorts within each population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Patients - Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure | Systolic and diastolic blood pressure of patients treated by the participating clinician trainees as reported in the Electronic Medical Record. | 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. | Posted | Mean | Standard Deviation | mm Hg | Control period is 6 months before the intervention and intervention period is up to 6 months after the intervention |
|
6 months after the intervention
No adverse events (defined as "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research") were expected or noted among the participating healthcare trainees who received this educational intervention Patients did not have adverse events collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthcare Trainees | Within each academic year, trainee clusters are assigned1 of 5 start date training times for Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period. CONSULT-BP Educational Intervention: Our intervention comprised two sessions 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 proposed by Cooper (Cooper L. Why Are Health Disparities Everyone's Problem? . Baltimore: Johns Hopkins University Press; 2021.) and (2) skill practice using 2 standardized patient simulated clinical encounters focusing on hypertension management challenges. The second session lasted 4 hours. Between the two sessions, trainees were asked to complete a race/ethnicity-compliance implicit association test and were provided the results to build self-awareness of potential implicit bias. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Tjia | UMass Chan Medical School | 774-455-3538 | jennifer.tjia@umassmed.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2024 | May 10, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D063505 | Racism |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011287 | Prejudice |
| D012919 | Social Behavior |
Not provided
Not provided
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.
Not provided
Not provided
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.
Not provided
|
| During CONSULT-BP session 2 clinician training intervention (simulated standardized patient encounter) |
| Uxbridge |
| Massachusetts |
| 01569 |
| United States |
| UMass Memorial Hahnemann Family Health Center | Worcester | Massachusetts | 01605 | United States |
| UMass Memorial Medical Center -- Benedict Building | Worcester | Massachusetts | 01605 | United States |
| 37462563 | Background | Calista J, Esparza N, Fernandez J, Beltran A, Bradshaw J, Casseres A, Duodu S, Duodu V, Fordjour C, Kuffour B, Mensah L, Negron-Cruz L, Pietri C, Pridgen C, Puerto G, Tessler LA, Tucci S, Wood K, Wright S, Zinkus P, Tjia J. Perspectives of Community Partners Involved in an Academic Training to Address Clinicians' Implicit Bias. Prog Community Health Partnersh. 2023;17(2):347-351. doi: 10.1353/cpr.2023.a900215. |
Patients treated by healthcare trainees within the control period |
| BG002 | Patients - Intervention Arm | Patients treated by healthcare trainees within the intervention period |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Patient BPs from after the CONSULT-BP Intervention taken from the Electronic Medical Record.
|
|
| 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. | RELATE scores were obtained from "standardized patients" (or mock patients) during interaction with the Clinician Trainees. | Posted | Mean | Standard Deviation | score on a scale | During CONSULT-BP session 2 clinician training intervention (simulated standardized patient encounter) |
|
|
|
| 0 |
| 118 |
| 0 |
| 118 |
| 0 |
| 118 |
| EG001 | Patients - Control Arm | Patients clustered within trainees in pre-training control period | 0 | 944 | 0 | 944 | 0 | 944 |
| EG002 | Patients - Intervention Arm | Patients clustered within trainees in post-training intervention period | 0 | 1,651 | 0 | 1,651 | 0 | 1,651 |
Not provided
Not provided
| D001519 |
| Behavior |
| D063508 | Social Discrimination |