Clinical trial NCT02936609: Assessing Community Cancer Care After Insurance ExpanSionS
Official title: Assessing Community Cancer Care After Insurance ExpanSionS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: healthcare access
healthcare utilization
preventive services
cancer survivors
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: OCHIN, Inc.
name: Health Choice Network
name: Fenway Community Health
name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2016-10-18
Enrollment: 1939783
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study eligible patients within electronic health record data from the ADVANCE CDRN of PCORnet

Brief summary: This innovative and timely study will measure the impact of Affordable Care Act (ACA) Medicaid expansions on cancer screenings and preventive services. To assess this natural policy experiment, the investigators will use electronic health record data from the Accelerating Data Value Across a National Community Health Center Network (ADVANCE) clinical data research network (CDRN) of the National Patient-Centered Clinical Research Network (PCORnet).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in number of preventive services received
timeFrame: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
Secondary outcomes:
measure: Change in type of preventive services received
timeFrame: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
measure: Change of health insurance status
timeFrame: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
measure: Change in number of primary care visits
timeFrame: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
measure: Change in type of primary care visits
timeFrame: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.