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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05278806
Other study ID # 2022P000354
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 24, 2022
Est. completion date April 30, 2023

Study information

Verified date June 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

A clinical program will be implemented to utilize the equity dashboard in routine clinical practice augmented by clinical support to address current disparities in hypertension control among MGH primary care patients who are Black, Indigenous and People of Color (BIPOC) as well as patients with limited English proficiency (LEP). The clinical support will be provided by population health coordinators (PHCs) and/or community health workers (CHWs). To evaluate the program, the investigators propose a stepped wedge design that will randomize the primary care providers to the provision of the equity dashboard and additional clinical support at different intervals. The primary reason to randomize the primary care providers is because the PHCs and CHWs have limited capacity to contact and assist the patients in our primary care practices with poorly controlled hypertension and can only engage a limited number of patients at a time. The stepped wedge cluster-randomized study design will randomize providers in all 15 MGH primary care practices to receiving the intervention (i.e. equity dashboard with additional clinical support) in twelve groups. Each step will be a one-month period. Providers randomized to Group 1 will receive the equity dashboard data as well as additional clinical support starting in Step 1 while providers randomized to Group 12 will receive the same intervention at the beginning of Step 12 but receive usual care in Steps 0-11. We will match Providers in the opposite steps (e.g. Group 1 vs. Group 12, Group 2 vs. Group 11, etc.) by practice, baseline hypertension control rate, and the number of patients in their panel who are eligible for the intervention to ensure balance between data collected from the intervention periods and control periods. The stepped wedge design will allow for an open cohort (i.e. new patients of the providers allocated to the intervention can enter in subsequent steps) and a repeated measures data analysis with the same patients experiencing both control and intervention conditions.


Recruitment information / eligibility

Status Completed
Enrollment 10766
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility <Provider Eligibility> Inclusion Criteria: • Massachusetts General Hospital primary care physician Exclusion Criteria: • Practice leaders and equity steering committee members as they will all get access to the equity dashboard data. <Patient Eligibility> Inclusion Criteria: • Uncontrolled Hypertension AND Black, Indigenous and People of Color (BIPOC) patients or Limited English proficiency (LEP). Exclusion Criteria: • Not deemed appropriate for intervention by their primary care provider due to terminal illness, advanced dementia, etc.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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. 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 and Population Health Coordinator 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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Hemoglobin A1c control Most recent HbA1C in the last 12 months was <7.0% OR
Most recent HbA1C within the last 6 months was = 9.0%
1 year
Secondary Breast cancer screening rates Completed a mammogram in the past 2 years 1 year
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