- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03545763
Evaluating Control of Hypertension - Effect of Social Determinants (ECHOES)
April 20, 2022 updated by: Jennifer E DeVoe, MD DPhil, Oregon Health and Science University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
1400000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Irina Chamine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- Patients in intervention and control states aged 19-64
Exclusion Criteria:
- Patients outside of age range 19-64
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Medicaid Expansion States
Patients receiving care in community health centers in states that expanded Medicaid (intervention group)
|
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)
|
There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months prior to Medicaid expansion vs 24 months post
|
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).
|
24 months prior to Medicaid expansion vs 24 months post
|
Hypertension screening
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
|
rate of blood pressure screening marked in EHR
|
24 months prior to Medicaid expansion vs 24 months post
|
Hypertension treatment
Time Frame: 24 months prior to Medicaid expansion vs 24 months post
|
the number of anti-hypertensive medications prescribed in EHR
|
24 months prior to Medicaid expansion vs 24 months post
|
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
|
24 months prior to Medicaid expansion vs 24 months post
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months prior to Medicaid expansion vs 24 months post
|
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
|
24 months prior to Medicaid expansion vs 24 months post
|
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
|
24 months prior to Medicaid expansion vs 24 months post
|
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
|
24 months prior to Medicaid expansion vs 24 months post
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2018
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
April 1, 2023
Study Registration Dates
First Submitted
May 22, 2018
First Submitted That Met QC Criteria
June 1, 2018
First Posted (Actual)
June 4, 2018
Study Record Updates
Last Update Posted (Actual)
April 22, 2022
Last Update Submitted That Met QC Criteria
April 20, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HL136575 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Recruiting
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
Clinical Trials on Medicaid Expansion
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); National Institutes of Health (NIH); Fenway... and other collaboratorsCompleted
-
Oregon Health and Science UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Centers... and other collaboratorsCompletedDiabetes Mellitus (DM)
-
University of California, Los AngelesUniversity of MichiganActive, not recruitingMedicaid Expansion, High-value Care, Low-value CareUnited States
-
Oregon Health and Science UniversityAgency for Healthcare Research and Quality (AHRQ); OCHIN, Inc.Completed
-
Dartmouth-Hitchcock Medical CenterState of New Hampshire Bureau of Behavioral HealthCompletedObesity | Mental Illness | Tobacco DependenceUnited States
-
Saint Thomas Hospital, PanamaCompletedBlunt Expansion of the Uterine IncisionPanama
-
Shanghai Jiao Tong University School of MedicineCompletedTissue Expander DisorderChina
-
Universidade Federal de GoiasUnknown
-
Michigan State UniversitySpectrum Health HospitalsCompletedStress | Child Development | Perinatal Depression | Prenatal Health Risk BehaviorsUnited States
-
Pontifícia Universidade Católica de Minas GeraisCompletedCleft Lip and Palate | Nasal Septum; Deviation, Congenital | Maxillary Hypoplasia