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

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ClinicalTrials.gov Identifier: NCT03545763
Recruitment Status : Active, not recruiting
First Posted : June 4, 2018
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
Ochin, Inc.
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Health Choice Network
Fenway Community Health
Information provided by (Responsible Party):
Jennifer E DeVoe, MD DPhil, Oregon Health and Science University

Brief Summary:
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.

Condition or disease Intervention/treatment
Hypertension Other: Medicaid Expansion

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.

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Study Type : Observational
Estimated Enrollment : 1400000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluating Control of Hypertension - Effect of Social Determinants
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicaid

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • Patients in intervention and control states aged 19-64

Exclusion Criteria:

  • Patients outside of age range 19-64

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545763


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Ochin, Inc.
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Health Choice Network
Fenway Community Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer E DeVoe, MD DPhil, Chair of the Department of Family Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03545763     History of Changes
Other Study ID Numbers: R01HL136575 ( U.S. NIH Grant/Contract )
R01HL136575 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer E DeVoe, MD DPhil, Oregon Health and Science University:
Hypertension
Social Determinants of Health
Health Insurance
Medicaid
Affordable Care Act
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases