Clinical trial NCT03545763: Evaluating Control of Hypertension - Effect of Social Determinants
Official title: Evaluating Control of Hypertension - Effect of Social Determinants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Social Determinants of Health
Health Insurance
Medicaid
Affordable Care Act
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: OCHIN, Inc.
name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Health Choice Network
name: Fenway Community Health
First posted: 2018-06-04
Enrollment: 1939783
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients in intervention and control states aged 19-64

Exclusion Criteria:

* Patients outside of age range 19-64

Primary outcomes:
measure: Hypertension incidence
timeFrame: 24 months prior to Medicaid expansion vs 24 months post
measure: Undiagnosed hypertension
timeFrame: 24 months prior to Medicaid expansion vs 24 months post
measure: Hypertension screening
timeFrame: 24 months prior to Medicaid expansion vs 24 months post
measure: Hypertension treatment
timeFrame: 24 months prior to Medicaid expansion vs 24 months post
measure: Hypertension management
timeFrame: 24 months prior to Medicaid expansion vs 24 months post
Secondary outcomes:
measure: Insurance status and rates of coverage
timeFrame: 24 months prior to Medicaid expansion vs 24 months post
measure: Service Utilization
timeFrame: 24 months prior to Medicaid expansion vs 24 months post
measure: Preventive service receipt
timeFrame: 24 months prior to Medicaid expansion vs 24 months post
measure: Hypertension related complications
timeFrame: 24 months prior to Medicaid expansion vs 24 months post
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
citation: Huguet N, Larson A, Angier H, Marino M, Green BB, Moreno L, DeVoe JE. Rates of Undiagnosed Hypertension and Diagnosed Hypertension Without Anti-hypertensive Medication Following the Affordable Care Act. Am J Hypertens. 2021 Sep 22;34(9):989-998. doi: 10.1093/ajh/hpab069.
citation: Angier H, Huguet N, Marino M, Green B, Holderness H, Gold R, Hoopes M, DeVoe J. Observational study protocol for evaluating control of hypertension and the effects of social determinants. BMJ Open. 2019 Mar 15;9(3):e025975. doi: 10.1136/bmjopen-2018-025975.