Evaluating Control of Hypertension - Effect of Social Determinants

Hypertension Clinical Trial

— ECHOES  

Official title:

Evaluating Control of Hypertension - Effect of Social Determinants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545763
• Other study ID #: R01HL136575
• Secondary ID: R01HL136575
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: May 15, 2023

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1939783
• Est. completion date: May 15, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• Patients in intervention and control states aged 19-64

Exclusion Criteria:

• Patients outside of age range 19-64

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (6)

Lead Sponsor	Collaborator
Oregon Health and Science University	Fenway Community Health, Health Choice Network, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), OCHIN, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypertension incidence	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
Primary	Undiagnosed hypertension	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
Primary	Hypertension screening	rate of blood pressure screening marked in EHR	24 months prior to Medicaid expansion vs 24 months post
Primary	Hypertension treatment	the number of anti-hypertensive medications prescribed in EHR	24 months prior to Medicaid expansion vs 24 months post
Primary	Hypertension management	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	Insurance status and rates of coverage	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
Secondary	Service Utilization	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
Secondary	Preventive service receipt	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
Secondary	Hypertension related complications	incidence of related complications and diseases derived from EHR data	24 months prior to Medicaid expansion vs 24 months post