COmmuNity-engaged SimULation Training for Blood Pressure Control (CONSULT-BP)

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. We hypothesize that patients' outcomes (blood pressure levels) will be lower after the training intervention compared with before training (control) periods.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: CONSULT-BP Educational Intervention

Detailed Description

CONSULT-BP will adapt and test a theory-based, 'awareness, exposure and skill-building' intervention, applied in the safety of a simulation-based learning center, to improve providers' interaction skills with minority and poor patients. We will use our established platform of community-based participatory research to implement CONSULT-BP in an academic medical center with a large, safety-net health system that serves a minority and poor population. The CONSULT-BP project will: 1. recruit and hire Community Advisors (CA) representing diverse underserved populations who will participate in the adaptation of evidence-based hypertension communication tools and the design, development, and implementation of the training curriculum; 2. use online self-assessments of clinicians' implicit bias for race and patient compliance to raise bias self-awareness and to examine the effect of bias on knowledge and skill development; and 3. hire Community SPs to (a) conduct face-to-face, simulated clinical encounters with medical trainees and NP students, and (b) provide evaluation and feedback about communication skills along with trained CA observers and faculty facilitators. The educational intervention is a program of two, 180-minute, sessions, spaced 5 weeks apart that combine online learning with in-person skill practice.

To understand how much training exposure is required to 'move the needle' of clinical skills and patient outcomes, we will assess the effect of CONSULT-BP by conducting two, sequential, randomized trials. Trial 1 will evaluate the effectiveness of one-time CONSULT training on outcomes, and Trial 2 will evaluate the effect of repeat, booster training on outcomes. To support training feasibility in Trial 1, CONSULT-BP will train cohorts of IM, FM, and NP trainees over a 3-year period, and will target advanced (2nd or 3rd-year) trainees within a given academic year for one-time exposure to the training intervention. Within each academic year, we will randomize training times to 1 of 5 start dates using a stepped wedge design to accommodate pre-existing training schedules and to mitigate the effect of temporal trends in clinical skill proficiency. Trial 2 will randomly assign continuing trainee participants from Trial 1 to a second CONSULT-BP booster training exposure versus no booster training. The primary outcome for both trials will be patient BP control. Secondary process outcomes will include trainees' communication skills and patient adherence to medications, visits, and diet changes. We will also examine effect modification by patient characteristics (baseline BP control) and trainee characteristics (implicit bias and awareness of bias). Trainee measures will be from trainee self-report (implicit bias, bias awareness), community SP report (trainee communication skills), and clinic patient surveys (trainee communication quality and patient adherence). Clinical BP outcomes will be from the EMR. We will use analytic mixed effect models accounting for patient and clinician characteristics, patient correlations within randomization clusters and within clinicians, and repeated measures within patient. The CONSULT-BP multi-staged, community-engaged, education model will change how medical educators think about helping providers develop bias-aware, patient-centered, communication skills.

• Study Type: Interventional
• Enrollment (Anticipated): 205
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Tjia, MD, MSCE; Phone Number: 774-455-3538; Email: jennifer.tjia@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Barre, Massachusetts, United States, 01005
      • Barre Family Health Center
    • Uxbridge, Massachusetts, United States, 01569
      • Tri River Family Health Center
    • Worcester, Massachusetts, United States, 01605
      • Edward M Kennedy Community Health Center
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Hahnemann Family Health Center
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center -- Benedict Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthcare Trainees - Cluster 1; Within each academic year, trainee clusters are randomized to 1 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.	Other: CONSULT-BP Educational Intervention; The CONSULT-BP intervention includes two, 180-minute, in-persons sessions 5 weeks apart. Each session has 3 parts: 1. Pre-"Clinical Practice Simulation" Learning; 2. Trainee Self-Assessments of implicit bias; and 3. In-Person "Clinical Practice Simulations" to practice communication skills, trigger reflection, and frame group-based reflections on bias.
Other: Healthcare Trainees - Cluster 2; Within each academic year, trainee clusters are randomized to 1 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.	Other: CONSULT-BP Educational Intervention; The CONSULT-BP intervention includes two, 180-minute, in-persons sessions 5 weeks apart. Each session has 3 parts: 1. Pre-"Clinical Practice Simulation" Learning; 2. Trainee Self-Assessments of implicit bias; and 3. In-Person "Clinical Practice Simulations" to practice communication skills, trigger reflection, and frame group-based reflections on bias.
Other: Healthcare Trainees - Cluster 3; Within each academic year, trainee clusters are randomized to 1 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.	Other: CONSULT-BP Educational Intervention; The CONSULT-BP intervention includes two, 180-minute, in-persons sessions 5 weeks apart. Each session has 3 parts: 1. Pre-"Clinical Practice Simulation" Learning; 2. Trainee Self-Assessments of implicit bias; and 3. In-Person "Clinical Practice Simulations" to practice communication skills, trigger reflection, and frame group-based reflections on bias.
Other: Healthcare Trainees - Cluster 4; Within each academic year, trainee clusters are randomized to 1 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.	Other: CONSULT-BP Educational Intervention; The CONSULT-BP intervention includes two, 180-minute, in-persons sessions 5 weeks apart. Each session has 3 parts: 1. Pre-"Clinical Practice Simulation" Learning; 2. Trainee Self-Assessments of implicit bias; and 3. In-Person "Clinical Practice Simulations" to practice communication skills, trigger reflection, and frame group-based reflections on bias.
Other: Healthcare Trainees - Cluster 5; Within each academic year, trainee clusters are randomized to 1 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.	Other: CONSULT-BP Educational Intervention; The CONSULT-BP intervention includes two, 180-minute, in-persons sessions 5 weeks apart. Each session has 3 parts: 1. Pre-"Clinical Practice Simulation" Learning; 2. Trainee Self-Assessments of implicit bias; and 3. In-Person "Clinical Practice Simulations" to practice communication skills, trigger reflection, and frame group-based reflections on bias.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Systolic and diastolic blood pressure reported in the EMR	up to 6 months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Communication	Health Care Climate Questionnaire Six-item scale assesses beliefs regarding perceived provider support for autonomy and provider communicated care. Each item is evaluated on 7-point Likert scale (1 - 5 strongly agree, neutral, strongly disagree). Scores are calculated by averaging individual item scores. (Williams 1998 (a); Williams 1998(b)) Reference. Williams GC, Rodin GC, Ryan RM, Grolnick WS, Deci EL. Autonomous regulation and long-term medication adherence in adult outpatients. Health Psychol. 1998;17(3):269-276. doi:10.1037/0278-6133.17.3.269. Williams GC, Freedman ZR, Deci EL. Supporting autonomy to motivate patients with diabetes for glucose control. Diabetes Care. 1998;21(10):1644-1651. doi:10.2337/diacare.21.10.1644	up to 3 months after the intervention
Patient Reported Trust in Heathcare Provider	The Primary Care Assessment Survey - Trust sub-scale Eight-item subscale of the the Primary Care Assessment measuring patient trust in their healthcare provider; each item is rated on a 5-point Likert Scale and transformed to a 100 point scale with higher scores indicating greater trust. The reported mean score is 75.68 (SD 16.04). Reference. Safran DG, Kosinski M, Tarlov AR, et al. The Primary Care Assessment Survey: tests of data quality and measurement performance. Med Care. 1998;36(5):728-739.	up to 3 months after the intervention
Voils Medication Adherence Scale	Twenty-four item scale assess extent and reasons for non-adherence to medication. Each item is rated on a 5-point Likert scale. Summary scores are calculated separately for reason and extent of adherence. Reference: Voils CI, Maciejewski ML, Hoyle RH, Reeve BB, Gallagher P, Bryson CL, Yancy WS Jr. Initial validation of a self-report measure of the extent of and reasons for medication nonadherence. Med Care. 2012;50(12):1013-9.	up to 3 months after the intervention
Blood Pressure Self Care Scale	Ten-item scale assesses knowledge and self-care practices on a 7-point Likert scale. Total scores are determined as the average of the scores on each item. Reference: Peters, R. M., & Templin, T. N. Measuring blood pressure knowledge and self-care behaviors of African Americans. Research in Nursing & Health, 2008; 31(6), 543-552.	up to 3 months after the intervention

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Jennifer Tjia, MD, MSCE, UMass Medical School

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Healthcare disparities; Racial Bias
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: H00012160; 1R01MD011532 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No