NCT02936609

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).

Trial Health

100
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 2016

Longer than P75 for all trials

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, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

4.9 years

First QC Date

October 14, 2016

Last Update Submit

April 20, 2022

Conditions

Keywords

healthcare accesshealthcare utilizationpreventive servicescancer survivors

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    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

    Less than or equal to 24 months prior to Medicaid expansion vs greater than or equal to 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

Medicaid Non-Expansion States

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

Other: Medicaid Expansion

Interventions

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

Medicaid Expansion StatesMedicaid Non-Expansion States

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Study eligible patients within electronic health record data from the ADVANCE CDRN of PCORnet

You may qualify if:

  • Patients in intervention and control states aged 19-64

You may not qualify if:

  • Patients at intervention and control clinics outside of the age range 19-64

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
9 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 18, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share