Clinical trial NCT03375918: COmmuNity-engaged SimULation Training for Blood Pressure Control
Official title: COmmuNity-engaged SimULation Training for Blood Pressure Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Healthcare disparities
Racial Bias
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2017-12-18
Enrollment: 205
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Clusters of clinical trainees \[stratified by specialty (internal medicine (IM), family medicine (FM), NP students) and by training block\] will be randomly assigned to 1 of 5 start dates. Clinical outcomes will be assessed at the patient level.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility 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

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

Primary outcomes:
measure: Blood pressure
timeFrame: up to 6 months after the intervention
Secondary outcomes:
measure: Quality of Communication
timeFrame: up to 3 months after the intervention
measure: Patient Reported Trust in Heathcare Provider
timeFrame: up to 3 months after the intervention
measure: Voils Medication Adherence Scale
timeFrame: up to 3 months after the intervention
measure: Blood Pressure Self Care Scale
timeFrame: up to 3 months after the intervention
Other outcomes:
Locations:
city: Barre
country: United States
facility: Barre Family Health Center
state: Massachusetts
city: Uxbridge
country: United States
facility: Tri River Family Health Center
state: Massachusetts
city: Worcester
country: United States
facility: Edward M Kennedy Community Health Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Hahnemann Family Health Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center -- Benedict Building
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Jennifer Tjia, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.