NCT05278806

Brief Summary

In this project, the impact of providing a practice-level equity dashboard that displays ambulatory quality outcome metrics stratified by race and language to primary care providers at Massachusetts General Hospital (MGH) will be evaluated. Provision of the dashboard data will be paired with additional clinical support focused on hypertension control among Black, Indigenous and People of Color (BIPOC) and patients with limited English proficiency (LEP). The investigators hypothesize that there will be a improvement in hypertension control (primary outcome), diabetes control and breast cancer screening (secondary outcomes) among Black, Indigenous and People of Color (BIPOC) and patients with limited English proficiency (LEP) in the intervention period compared to the control period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,766

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

March 24, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

November 9, 2021

Last Update Submit

June 23, 2023

Conditions

Keywords

EquityHealth Disparities

Outcome Measures

Primary Outcomes (1)

  • Hypertension control

    * Blood pressure (BP) measured in the last 12 months AND last BP or average of last three BP readings (in the last 18 months) \<130/80 or * BP measured within past 6 months AND either the last or average of last three BP readings (in the last 18 months) meet one of the following criteria: * Age \< 60, BP ≤ 140/90 * Age ≥ 60 with Diabetes, BP ≤ 140/90; without Diabetes, BP ≤ 150/90 * Age ≥ 60, Diastolic BP \< 70, regardless of Systolic * On three or more anti-hypertensive medications from three different classes

    1 year

Secondary Outcomes (2)

  • Hemoglobin A1c control

    1 year

  • Breast cancer screening rates

    1 year

Study Arms (4)

Equity Dashboard, Population Health Coordinator and Community Health Worker Support

EXPERIMENTAL

After the step in which the primary care providers are randomized to receiving intervention, one group of providers will receive the equity dashboard data and complete an equity huddle where they will review their list of eligible patients (Black, Indigenous and People of Color \[BIPOC\] patients and patients with limited English proficiency \[LEP\]) with a population health coordinator (PHC). The goal of the equity huddle will be to develop a plan to improve eligible patients' hypertension control. One of the options will be to refer patients to a community health worker (CHW) program focused specifically on addressing hypertension.

Other: Equity Dashboard, Population Health Coordinator and Community Health Worker Support

Equity Dashboard and Population Health Coordinator Support

EXPERIMENTAL

After the step in which the primary care providers are randomized to receiving intervention, a second group of providers will receive the equity dashboard data and complete an equity huddle where they will review their list of eligible patients (Black, Indigenous and People of Color \[BIPOC\] patients and patients with limited English proficiency \[LEP\]) with a population health coordinator (PHC). The goal of the equity huddle will be to develop a plan to improve eligible patients' hypertension control.

Other: Equity Dashboard and Population Health Coordinator Support

Delayed intervention

NO INTERVENTION

Black, Indigenous and People of Color (BIPOC) patients and patients with limited English proficiency (LEP) before their primary care providers are randomized to receiving the intervention. (By the end of the 12 steps, all BIPOC/LEP patients will be assigned to an experimental group)

Usual Care

NO INTERVENTION

Patients who are not eligible for additional clinical support (i.e. White and English speaking patients).

Interventions

Providers will be given access to an equity dashboard that displays their practice's performance on ambulatory quality metrics stratified by race and language. Population health coordinators (PHCs) will lead equity huddles with providers to review list of patients who are not at goal for their hypertension control and meet the inclusion criteria. Providers will formulate a follow up plan for each patient that the PHCs will help implement. For example, PHCs may contact patient via the online patient portal or phone to obtain recent home blood pressure readings, facilitate scheduling of follow up visits, etc. In addition, patients may be referred to the community health worker (CHW) hypertension management program. Patients will work with the CHW for 3-6 months. During this time the CHW will focus their efforts on patient education/coaching, remote blood pressure monitoring, addressing psychosocial and socioeconomic barriers to care and care coordination.

Equity Dashboard, Population Health Coordinator and Community Health Worker Support

Providers will be given access to an equity dashboard that displays their practice's performance on ambulatory quality metrics stratified by race and language. In addition, population health coordinators (PHCs) will lead disparities focused huddles with providers. During the huddle, they will review list of patients who are not at goal for their hypertension control and meet the inclusion criteria. Providers will then formulate a follow up plan for each patient that the Population Health Coordinators will help implement. For example, PHCs may contact patient via the online patient portal or phone to obtain recent home blood pressure readings, facilitate scheduling of follow up visits, etc.

Equity Dashboard and Population Health Coordinator Support

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Massachusetts General Hospital primary care physician

You may not qualify if:

  • Practice leaders and equity steering committee members as they will all get access to the equity dashboard data.
  • \<Patient Eligibility\>
  • Uncontrolled Hypertension AND Black, Indigenous and People of Color (BIPOC) patients or Limited English proficiency (LEP).
  • Not deemed appropriate for intervention by their primary care provider due to terminal illness, advanced dementia, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Hwang AS, Chang Y, Matathia S, Brodney S, Barry MJ, Horn DM. Effectiveness of a Population Health Intervention on Disparities in Hypertension Control: A Stepped Wedge Cluster Randomized Clinical Trial. J Gen Intern Med. 2024 Nov;39(15):3028-3034. doi: 10.1007/s11606-024-08839-y. Epub 2024 Jun 12.

MeSH Terms

Conditions

HypertensionDiabetes MellitusBreast Neoplasms

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Andrew S Hwang, MD/MPH

    MGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Physician

Study Record Dates

First Submitted

November 9, 2021

First Posted

March 14, 2022

Study Start

March 24, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations