Evaluating Control of Hypertension - Effect of Social Determinants

NCT ID: NCT03545763

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1939783 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2023-05-15

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.

Conditions

Hypertension

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Medicaid Expansion States

Patients receiving care in community health centers in states that expanded Medicaid (intervention group)

Medicaid Expansion

Intervention Type: OTHER

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)

Medicaid Expansion

Intervention Type: OTHER

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

Interventions

Medicaid Expansion

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients in intervention and control states aged 19-64

Exclusion Criteria

• Patients outside of age range 19-64

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OCHIN, Inc.

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Health Choice Network

OTHER

Sponsor Role: collaborator

Fenway Community Health

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer E DeVoe, MD DPhil

Chair of the Department of Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33929496 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30878987 (View on PubMed)

Other Identifiers

R01HL136575

Identifier Type: NIH

Identifier Source: secondary_id

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R01HL136575

Identifier Type: NIH

Identifier Source: org_study_id

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