NCT03545763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,939,783

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

May 22, 2018

Last Update Submit

April 16, 2024

Conditions

Hypertension

Keywords

HypertensionSocial Determinants of HealthHealth InsuranceMedicaidAffordable Care Act

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • Hypertension screening

    rate of blood pressure screening marked in EHR

    24 months prior to Medicaid expansion vs 24 months post

  • Hypertension treatment

    the number of anti-hypertensive medications prescribed in EHR

    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

    24 months prior to Medicaid expansion vs 24 months post

Secondary Outcomes (4)

  • Insurance status and rates of coverage

    24 months prior to Medicaid expansion vs 24 months post

  • Service Utilization

    24 months prior to Medicaid expansion vs 24 months post

  • Preventive service receipt

    24 months prior to Medicaid expansion vs 24 months post

  • Hypertension related complications

    24 months prior to Medicaid expansion vs 24 months post

Study Arms (2)

Medicaid Expansion States

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

Other: Medicaid Expansion

Non Medicaid Expansion States

Patients receiving care in community health centers in states that did not expand Medicaid (control group)

Other: Medicaid Expansion

Interventions

Medicaid ExpansionOTHER

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

Medicaid Expansion StatesNon Medicaid Expansion States

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Patients in intervention and control states aged 19-64

You may not qualify if:

  • Patients outside of age range 19-64

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

  • 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.

    PMID: 33929496DERIVED

  • 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.

    PMID: 30878987DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of the Department of Family Medicine

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 4, 2018

Study Start

April 1, 2018

Primary Completion

April 1, 2023

Study Completion

May 15, 2023

Last Updated

April 18, 2024

Record last verified: 2024-04

Locations

US(1)