Evaluating Control of Hypertension - Effect of Social Determinants (ECHOES)

April 20, 2022 updated by: Jennifer E DeVoe, MD DPhil, Oregon Health and Science University
This study evaluates the impact of a large-scale, national expansion of Medicaid on hypertension incidence, screening, treatment, and management. Social Determinants of Health will be assessed as moderators, and comparing states that did versus states that did not expand Medicaid will also be evaluated.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The Affordable Care Act (ACA) enacted several provisions intended to improve healthcare for vulnerable populations,including expanding Medicaid eligibility to those earning ≤138% of the federal poverty level (FPL). Since the expansion was not required, as of March 2018, 32 states (and District of Columbia) implemented the expansion and 18 did not. Simulated models predicted the ACA would improve health outcomes and reduce disparities for patients with hypertension, yet actual changes are not yet available. In addition, there is new interest in tracking and utilizing Social Determinants of Health (SDH) in the primary care setting but there is currently little information on how this information will impact Hypertension (HTN) care, especially related to changes to health insurance availability. This study will build on current understanding of how health insurance impacts HTN incidence, screening, treatment, and management by comparing states that did versus did not expand Medicaid as part of the ACA and seeks to understand the influence of SDH on these changes. the investigators will address the following specific aims: Aim 1: Compare HTN incidence, prevalence of undiagnosed HTN, and rates of HTN screening, in Medicaid expansion versus non-expansion states before and after the ACA. Aim 2: Compare HTN treatment (e.g., medication use), and management (e.g., HTN control, systolic and diastolic blood pressure change, risk factors related to HTN control) in Medicaid expansion versus non-expansion states before and after the ACA. Aim 3: Assess the extent to which rates of HTN incidence, screening, and treatment effectiveness among patients who gained insurance versus those continuously insured or uninsured, pre-post ACA, are moderated by individual-level SDH (e.g., race, ethnicity), in expansion states. Aim 4: Explore the interaction between community-level SDH (e.g., neighborhood racial segregation and deprivation) and HTN incidence, screening, treatment, and management among patients who gained insurance relative to those who were continuously insured or uninsured, in expansion states. The findings from this project will be extremely relevant to policy and practice, informing further improvements in the US healthcare system to ensure access to healthcare for vulnerable populations.

Study Type

Observational

Enrollment (Anticipated)

1400000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97239
        • Irina Chamine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study eligible patients within electronic health record data from the Accelerating Data Value Across a National Community Health Center Network (ADVANCE) community health information network

Description

Inclusion Criteria:

  • Patients in intervention and control states aged 19-64

Exclusion Criteria:

  • Patients outside of age range 19-64

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Medicaid Expansion States
Patients receiving care in community health centers in states that expanded Medicaid (intervention group)
There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not
Non Medicaid Expansion States
Patients receiving care in community health centers in states that did not expand Medicaid (control group)
There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertension incidence
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
Rates of hypertension diagnosis using the following codes in the EHR: ICD-9: 401.00-401.99, 402.00-405.99 or ICD-10: I10-I15.
24 months prior to Medicaid expansion vs 24 months post
Undiagnosed hypertension
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
high blood pressure but no diagnosis or medications can be noted in the EHR diagnostic codes that can be used to document why a diagnosis of hypertension was not made including ICD-10 R03.0 (i.e., white coat syndrome without HTN) and ICD-9 796.2 (i.e., elevated BP without HTN).
24 months prior to Medicaid expansion vs 24 months post
Hypertension screening
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
rate of blood pressure screening marked in EHR
24 months prior to Medicaid expansion vs 24 months post
Hypertension treatment
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
the number of anti-hypertensive medications prescribed in EHR
24 months prior to Medicaid expansion vs 24 months post
Hypertension management
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
blood pressure control: last measure within range of normal for age/risk(s); percent Y/N at last visit, value/date of last measure
24 months prior to Medicaid expansion vs 24 months post

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insurance status and rates of coverage
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
Health insurance status derived from EHR data and is primarily based on information collected at each visit
24 months prior to Medicaid expansion vs 24 months post
Service Utilization
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
Type of internal services utilized including number and ratio of "traditional" face to face visits vs. "nontraditional" encounters and communication via phone, personal health record, and email
24 months prior to Medicaid expansion vs 24 months post
Preventive service receipt
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
number of all billed encounters overall and yearly, as well as number of cancer screening, smoking screening, lipid screening, diabetes screening, obesity screening
24 months prior to Medicaid expansion vs 24 months post
Hypertension related complications
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
incidence of related complications and diseases derived from EHR data
24 months prior to Medicaid expansion vs 24 months post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 1, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HL136575 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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