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OpenTrials
Completed

NCT Number: NCT03545763

Evaluating Control of Hypertension - Effect of Social Determinants

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients in intervention and control states aged 19-64

Exclusion criteria

  • Patients outside of age range 19-64

Treatment and study plan

Medicaid Expansion

Other

There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not

Primary outcomes

  1. 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.

  2. 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).

  3. Hypertension screening

    Time frame: 24 months prior to Medicaid expansion vs 24 months post

    rate of blood pressure screening marked in EHR

  4. Hypertension treatment

    Time frame: 24 months prior to Medicaid expansion vs 24 months post

    the number of anti-hypertensive medications prescribed in EHR

  5. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Fenway Community Health
  • Health Choice Network
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)
  • OCHIN, Inc.

Registry information

Acronym: ECHOES

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2018
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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