CancerACCESSNCT02936609
Assessing Community Cancer Care After Insurance ExpanSionS
An observational study of Cancer, run by OHSU Knight Cancer Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Medicaid Expansion
- How many people
- 1,939,783 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Mar 2021
- How long will I take part?
- 9 Years
- 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
- Healthy volunteers accepted
- Adult
Study population: Study eligible patients within electronic health record data from the ADVANCE CDRN of PCORnet
Who may be able to join
- Patients in intervention and control states aged 19-64
Who cannot join
- Patients at intervention and control clinics outside of the age range 19-64
About this study
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).
Read the 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.
- Conditions
- Cancer
- Being tested
- Medicaid Expansion
- Keywords
- healthcare access, healthcare utilization, preventive services, cancer survivors
- Medical subject headings
- Neoplasms
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 | |
| Medicaid Non-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.
Change in number of preventive services received
Preventive services and screenings for cervical, colorectal, and breast cancers, HPV vaccinations, smoking screening ad interventions, and obesity screening and interventions.
Measured: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 24 months post
Secondary outcomes (4)
Change in type of preventive services received
Preventive services and screenings for cervical, colorectal, and breast cancers, HPV vaccinations, smoking screening ad interventions, and obesity screening and interventions
Measured: 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
Health insurance status derived from EHR data and is primarily based on information collected at each visit
Measured: 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
Number of primary care visits.
Measured: 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
Types of primary care visits.
Measured: Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 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 posted18 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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)
- Target duration
- 9 Years
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- OCHIN, Inc., Health Choice Network, Fenway Community Health, National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Jennifer Devoe, MD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936609
- Sponsor's protocol ID
- 1R01CA204267
- Acronym
- ACCESS
- Status last verified
- Apr 2022
- First submitted
- 14 Oct 2016
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 31123754Hoopes 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.
PubMed 31174231Hoopes 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.
PubMed 33377908Huguet 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.
PubMed 31077723Angier 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.
PubMed 32294251Angier 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.
PubMed 29473059
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Community Cancer Care After Insurance ExpanSionS
- ClinicalTrials.gov ID
- NCT02936609
- Acronym / sponsor ID
- ACCESS / 1R01CA204267
- Conditions
- Cancer
- Keywords
- healthcare access, healthcare utilization, preventive services, cancer survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,939,783 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- OCHIN, Inc., Health Choice Network, Fenway Community Health, National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- Apr 2016
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 18 Oct 2016 (estimated)
- 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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 9 Years
- 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) |
| Medicaid Non-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
- Accepted
- Age groups
- Adult
- Study population
- Study eligible patients within electronic health record data from the ADVANCE CDRN of PCORnet
Key inclusion criteria (1 listed)
- Patients in intervention and control states aged 19-64
Key exclusion criteria (1 listed)
- Patients at intervention and control clinics outside of the 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, Medicaid Non-Expansion States |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
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 28 Apr 2022.
- Results publication: PubMed 31123754Bailey 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.
- Results publication: PubMed 31174231Hoopes 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.
- Results publication: PubMed 33377908Hoopes 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.
- Results publication: PubMed 31077723Huguet 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.
- Results publication: PubMed 32294251Angier 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.
- Derived from this study: PubMed 29473059Angier 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.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by OHSU Knight Cancer Institute.
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 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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). 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 NCT02936609, which also lists 6 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 28 Apr 2022.