HypertensionECHOESNCT03545763
Evaluating Control of Hypertension - Effect of Social Determinants
An observational study of Hypertension, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Medicaid Expansion
- How many people
- 1,939,783 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 15 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- Patients in intervention and control states aged 19-64
Who cannot join
- Patients outside of age range 19-64
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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.
Read the 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
- Being tested
- Medicaid Expansion
- Keywords
- Hypertension, Social Determinants of Health, Health Insurance, Medicaid, Affordable Care Act
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicaid ExpansionOther
There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not
| Study group | Role | What they receive |
|---|---|---|
| Medicaid Expansion States | Patients receiving care in community health centers in states that expanded Medicaid (intervention group) Receives: Other: Medicaid Expansion | |
| Non Medicaid Expansion States | Patients receiving care in community health centers in states that did not expand Medicaid (control group) Receives: Other: Medicaid Expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months prior to Medicaid expansion vs 24 months post
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).
Measured: 24 months prior to Medicaid expansion vs 24 months post
Hypertension screening
rate of blood pressure screening marked in EHR
Measured: 24 months prior to Medicaid expansion vs 24 months post
Hypertension treatment
the number of anti-hypertensive medications prescribed in EHR
Measured: 24 months prior to Medicaid expansion vs 24 months post
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
Measured: 24 months prior to Medicaid expansion vs 24 months post
Secondary outcomes (4)
Insurance status and rates of coverage
Health insurance status derived from EHR data and is primarily based on information collected at each visit
Measured: 24 months prior to Medicaid expansion vs 24 months post
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
Measured: 24 months prior to Medicaid expansion vs 24 months post
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
Measured: 24 months prior to Medicaid expansion vs 24 months post
Hypertension related complications
incidence of related complications and diseases derived from EHR data
Measured: 24 months prior to Medicaid expansion vs 24 months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,939,783 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- OCHIN, Inc., National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Health Choice Network, Fenway Community Health
- Responsible party
- Principal investigator, Jennifer E DeVoe, MD DPhil, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545763
- Sponsor's protocol ID
- R01HL136575
- Other IDs
- R01HL136575
- Acronym
- ECHOES
- Status last verified
- Apr 2024
- First submitted
- 22 May 2018
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33929496Angier 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.
PubMed 30878987
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Control of Hypertension - Effect of Social Determinants
- ClinicalTrials.gov ID
- NCT03545763
- Acronym / sponsor ID
- ECHOES / R01HL136575
- Conditions
- Hypertension
- Keywords
- Hypertension, Social Determinants of Health, Health Insurance, Medicaid, Affordable Care Act
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,939,783 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- OCHIN, Inc., National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Health Choice Network, Fenway Community Health
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicaid Expansion States | – | Other: Medicaid ExpansionPatients receiving care in community health centers in states that expanded Medicaid (intervention group) |
| Non Medicaid Expansion States | – | Other: Medicaid ExpansionPatients receiving care in community health centers in states that did not expand Medicaid (control group) |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Patients in intervention and control states aged 19-64
Key exclusion criteria (1 listed)
- Patients outside of age range 19-64
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicaid ExpansionThere will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not | Other | Medicaid Expansion States, Non Medicaid Expansion States |
Primary outcome
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.
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).
Hypertension screening
Time frame: 24 months prior to Medicaid expansion vs 24 months post
rate of blood pressure screening marked in EHR
Hypertension treatment
Time frame: 24 months prior to Medicaid expansion vs 24 months post
the number of anti-hypertensive medications prescribed in EHR
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
4 secondary outcomes
Insurance status and rates of coverage
Time frame: 24 months prior to Medicaid expansion vs 24 months post
Service Utilization
Time frame: 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
Hypertension related complications
Time frame: 24 months prior to Medicaid expansion vs 24 months post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 33929496Huguet 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.
- Derived from this study: PubMed 30878987Angier 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.
- Individual participant dataSharing planned: Undecided
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension incidence (time frame: 24 months prior to Medicaid expansion vs 24 months post). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545763, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.