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

U

University of Massachusetts, Worcester

Status

Active, not recruiting

Conditions

Hypertension

Treatments

Other: CONSULT-BP Educational Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03375918
H00012160
1R01MD011532 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

205 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

205 participants in 5 patient groups

Healthcare Trainees - Cluster 1
Other group
Description:
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.
Treatment:
Other: CONSULT-BP Educational Intervention
Healthcare Trainees - Cluster 2
Other group
Description:
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.
Treatment:
Other: CONSULT-BP Educational Intervention
Healthcare Trainees - Cluster 3
Other group
Description:
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.
Treatment:
Other: CONSULT-BP Educational Intervention
Healthcare Trainees - Cluster 4
Other group
Description:
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.
Treatment:
Other: CONSULT-BP Educational Intervention
Healthcare Trainees - Cluster 5
Other group
Description:
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.
Treatment:
Other: CONSULT-BP Educational Intervention

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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