- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936609
Assessing Community Cancer Care After Insurance ExpanSionS (ACCESS)
Study Overview
Detailed Description
Cancer morbidity and mortality is greatly reduced through screening and prevention, but uninsured patients are much less likely than insured patients to receive these evidence-based services as recommended. In addition, uninsured cancer survivors receive fewer primary and preventive care services than those with health insurance. Thus, it is hypothesized that Affordable Care Act (ACA) Medicaid expansions could substantially improve access to essential cancer preventive and screening services for previously uninsured patients, and facilitate better care for cancer survivors who gain health insurance. In 2012, the United States (US) Supreme Court ruled that states were not legally required to implement ACA Medicaid expansions, creating a unique natural experiment to test this hypothesis. By April 1, 2015, 30 states and the District of Columbia had implemented expansions, and 20 states had not. This led to increased Medicaid enrollment by 26% in expansion states, compared to 8% in non-expansion states. Previous single-state Medicaid expansions led to increased utilization of healthcare services and improved health outcomes post-expansion. For example, in Oregon, cervical cancer screening rates were 18-19% higher among women who gained Medicaid in 2008, compared to those who remained uninsured. However, no previous assessments of state-specific expansions had concurrent control (non-expansion) states for comparison. Further, little is known about how Medicaid expansion impacts the delivery of recommended primary and preventive care services to cancer survivors, termed 'survivor care.'
The investigators propose to use the ACA Medicaid expansion natural experiment to study the effect of state-level Medicaid expansion on rates of cancer screening and preventive services ('cancer prevention') and survivor care. Many patients likely to gain coverage through ACA Medicaid expansions receive primary care in community health centers (CHCs), our nation's healthcare 'safety net;' thus, the proposed analyses will use electronic health record (EHR) data from the ADVANCE clinical data research network (CDRN) of CHCs (ADVANCE is one of 11 CDRNs in the national PCORnet data network). The ADVANCE CDRN has patient-level data from 476 CHCs in 13 Medicaid expansion states (n=576,711 patients) and 242 CHCs in 8 non-expansion states (n=361,421 patients). This nationally unique data resource will allow us to measure outcomes in expansion versus non-expansion states, illuminating the impact of increased Medicaid opportunities on rates of cancer prevention and survivor care within the safety net. The investigators will also assess whether disparities in delivery of this care are reduced. Our specific aims for this study, titled "Assessing Community Cancer care after insurance ExpanSionS (ACCESS)," are to:
Aim 1. Compare pre-post receipt of cancer prevention and screening among vulnerable CHC patients in Medicaid expansion versus non-expansion states.
Hypothesis 1a: Cancer prevention and screening will significantly increase among CHC patients in expansion states, compared to those in non-expansion states.
Hypothesis 1b: Racial/ethnic disparities in cancer prevention and screening will be significantly reduced in expansion states versus no change in non-expansion states.
Aim 2. Compare pre-post insurance status, visits, and receipt of routine, recommended primary and preventive care among cancer survivors seen in CHCs in expansion versus non-expansion states.
Hypothesis 2a: A higher percentage of uninsured cancer survivors will have gained insurance coverage in expansion states, compared to those in non-expansion states.
Hypothesis 2b: Cancer survivors who are CHC patients in expansion states will have a significant increase in visits, visits paid by Medicaid, and survivor care relative to no change among patients in non-expansion states.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients in intervention and control states aged 19-64
Exclusion Criteria:
- Patients at intervention and control clinics outside of the age range 19-64
Study Plan
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
|
Medicaid Non-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 |
---|---|---|
Change in number of preventive services received
Time Frame: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
|
Preventive services and screenings for cervical, colorectal, and breast cancers, HPV vaccinations, smoking screening ad interventions, and obesity screening and interventions.
|
Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in type of preventive services received
Time Frame: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
|
Preventive services and screenings for cervical, colorectal, and breast cancers, HPV vaccinations, smoking screening ad interventions, and obesity screening and interventions
|
Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
|
Change of health insurance status
Time Frame: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
|
Health insurance status derived from EHR data and is primarily based on information collected at each visit
|
Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
|
Change in number of primary care visits
Time Frame: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
|
Number of primary care visits.
|
Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
|
Change in type of primary care visits
Time Frame: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
|
Types of primary care visits.
|
Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Bailey SR, Marino M, Ezekiel-Herrera D, Schmidt T, Angier H, Hoopes MJ, DeVoe JE, Heintzman J, Huguet N. Tobacco Cessation in Affordable Care Act Medicaid Expansion States Versus Non-expansion States. Nicotine Tob Res. 2020 May 26;22(6):1016-1022. doi: 10.1093/ntr/ntz087.
- Hoopes M, Schmidt T, Huguet N, Winters-Stone K, Angier H, Marino M, Shannon J, DeVoe J. Identifying and characterizing cancer survivors in the US primary care safety net. Cancer. 2019 Oct 1;125(19):3448-3456. doi: 10.1002/cncr.32295. Epub 2019 Jun 7.
- Hoopes M, Voss R, Angier H, Marino M, Schmidt T, DeVoe JE, Soule J, Huguet N. Assessing Cancer History Accuracy in Primary Care Electronic Health Records Through Cancer Registry Linkage. J Natl Cancer Inst. 2021 Jul 1;113(7):924-932. doi: 10.1093/jnci/djaa210.
- Huguet N, Angier H, Rdesinski R, Hoopes M, Marino M, Holderness H, DeVoe JE. Cervical and colorectal cancer screening prevalence before and after Affordable Care Act Medicaid expansion. Prev Med. 2019 Jul;124:91-97. doi: 10.1016/j.ypmed.2019.05.003. Epub 2019 May 8.
- Angier HE, Marino M, Springer RJ, Schmidt TD, Huguet N, DeVoe JE. The Affordable Care Act improved health insurance coverage and cardiovascular-related screening rates for cancer survivors seen in community health centers. Cancer. 2020 Jul 15;126(14):3303-3311. doi: 10.1002/cncr.32900. Epub 2020 Apr 15.
- Angier H, Huguet N, Marino M, Mori M, Winters-Stone K, Shannon J, Raynor L, Holderness H, DeVoe JE. Assessing Community Cancer care after insurance ExpanSionS (ACCESS) study protocol. Contemp Clin Trials Commun. 2017 Sep;7:136-140. doi: 10.1016/j.conctc.2017.06.011. Epub 2017 Jun 24.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R01CA204267 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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