Clinical trial NCT02298361: IMPACCT for Kids' Care
Official title: Innovative Methods for Parents And Clinics to Create Tools (IMPACCT) for Kids' Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insurance Status/Stability
Keywords: Adolescent
Child
Child Health Services/organization & administration*
Child, Preschool
Cohort Studies
Community Health Centers/organization & administration
Community Health Centers/standards
Electronic Health Records
Feasibility Studies
Female
Health Services Accessibility/economics
Humans
Infant
Infant, Newborn
Insurance Coverage
Insurance Coverage/statistics & numerical data
Insurance Coverage/trends
Insurance, Health
Insurance, Health/legislation & jurisprudence
Insurance, Health/statistics & numerical data
Insurance, Health/trends
Logistic Models
Longitudinal Studies
Male
Medicaid
Medicaid/statistics & numerical data
Medicaid/trends
Medicaid/utilization
Medically Uninsured
Medicare/statistics & numerical data
Medicare/trends
Medicare/utilization
Multivariate Analysis
Oregon
Patient Protection and Affordable Care Act
Patient-Centered Care
Pediatrics/legislation & jurisprudence
Pediatrics/standards
Population Surveillance/methods
Primary Health Care/economics
Quality Assurance, Health Care/legislation & jurisprudence
Quality Assurance, Health Care/methods
Quality Indicators, Health Care
Retrospective Studies
Socioeconomic Factors
United States
Young Adult
Lead sponsor: OCHIN, Inc.
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2014-11-21
Enrollment: 27251
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the analysis of the primary study outcome, our study population will include all children who are "established" patients at an intervention or control clinic. Children will be considered "established" patients if they had \>=1 clinical visit at a study clinic during the 18-month study period.

Brief summary: Health insurance is important for children. Public insurance programs are available to many children, but some families report being confused about how to get and keep this insurance. Community Health Centers (CHCs) can help families get and keep health insurance for their children.

The investigators will work with families, policy makers, and community health care providers and staff to develop and test new computer health information technology (IT) tools to help health care clinics find pediatric patients in need of insurance and communicate with their families about public insurance programs. These tools will be based on technologies currently used to help patients and clinics manage chronic diseases. The investigators will test the tools by comparing four clinics using the tools and four clinics not using the tools. The investigators will look to see if children in the clinics using the tools are more likely to have health insurance and also more likely to receive certain health care services, compared to children in the clinics without such tools. The investigators will also look at health insurance rates and health care services for a larger population of Oregon children.

Detailed description: Summary of protocol changes made:

1. Changes to eligibility criteria. We changed patient eligibility to include all pediatric patients through age 19 with \>=1 clinical visit in the study period. These decisions were based on: 1) at age 20, individuals are no longer eligible for children's Medicaid or CHIP in Oregon; 2) identification of PCP assignment was difficult in the EHR.
2. Added second comparison group/study arm. In the intervention clinics, the tools were used on a smaller number of pediatric patients than anticipated, and there were significant demographic differences between intervention and control site patients, despite the clinics being matched. Thus we added a second comparison group, "within-clinic comparison patients" as pediatric patients with \>=1 visit at an intervention clinic in the study period but on whom the tools were NOT used. This provided a comparison group that accounted for clinic-level effects and was more demographically similar to the "intervention patients" on whom tools were used.
3. Revision of Aim 3 - CHIPRA recommended care assessment. We did not pursue assessment of CHIPRA quality care measures due to 1) limited follow-up time due to the need to implement iterative modifications to the study HIT tools, and 2) the tools were used on a smaller set of pediatric patients than anticipated, thus we had a very limited denominator for these analyses.

Eligibility criteria: Inclusion Criteria:

* age 0-19
* established patient (\>=1 clinical visit at a study clinic in the assessment period)

Exclusion Criteria:

* age \> 19
* not an established patient

Primary outcomes:
measure: Percent of Study Period Covered by Medicaid
timeFrame: 6 months pre- through 16 months post-tool implementation
measure: Proportion of Patients Who Gained Medicaid Coverage
timeFrame: 6 months pre- through 16 months post-tool implementation
measure: Proportion of Patients Who Lost Medicaid Coverage
timeFrame: 6 months pre- through 16 months post-tool implementation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: OCHIN, OHSU
name: Jennifer DeVoe, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: OCHIN, Inc.
name: Christine Nelson, RN, PhD
role: STUDY_DIRECTOR
References:
citation: Devoe JE. Being uninsured is bad for your health: can medical homes play a role in treating the uninsurance ailment? Ann Fam Med. 2013 Sep-Oct;11(5):473-6. doi: 10.1370/afm.1541.
citation: Angier H, Gold R, Crawford C, P O'Malley J, J Tillotson C, Marino M, DeVoe JE. Linkage methods for connecting children with parents in electronic health record and state public health insurance data. Matern Child Health J. 2014 Nov;18(9):2025-33. doi: 10.1007/s10995-014-1453-8.
citation: DeVoe J, Angier H, Likumahuwa S, Hall J, Nelson C, Dickerson K, Keller S, Burdick T, Cohen D. Use of qualitative methods and user-centered design to develop customized health information technology tools within federally qualified health centers to keep children insured. J Ambul Care Manage. 2014 Apr-Jun;37(2):148-54. doi: 10.1097/JAC.0000000000000016.
citation: DeVoe JE, Tillotson CJ, Angier H, Wallace LS. Predictors of children's health insurance coverage discontinuity in 1998 versus 2009: parental coverage continuity plays a major role. Matern Child Health J. 2015 Apr;19(4):889-96. doi: 10.1007/s10995-014-1590-0.
citation: Hatch B, Angier H, Marino M, Heintzman J, Nelson C, Gold R, Vakarcs T, Devoe J. Using electronic health records to conduct children's health insurance surveillance. Pediatrics. 2013 Dec;132(6):e1584-91. doi: 10.1542/peds.2013-1470. Epub 2013 Nov 18.
citation: Angier H, Likumahuwa S, Finnegan S, Vakarcs T, Nelson C, Bazemore A, Carrozza M, DeVoe JE. Using geographic information systems (GIS) to identify communities in need of health insurance outreach: An OCHIN practice-based research network (PBRN) report. J Am Board Fam Med. 2014 Nov-Dec;27(6):804-10. doi: 10.3122/jabfm.2014.06.140029.
citation: DeVoe JE, Angier H, Burdick T, Gold R. Health information technology: an untapped resource to help keep patients insured. Ann Fam Med. 2014 Nov-Dec;12(6):568-72. doi: 10.1370/afm.1721.
citation: Angier H, Hoopes M, Gold R, Bailey SR, Cottrell EK, Heintzman J, Marino M, DeVoe JE. An early look at rates of uninsured safety net clinic visits after the Affordable Care Act. Ann Fam Med. 2015 Jan-Feb;13(1):10-6. doi: 10.1370/afm.1741.
citation: Heintzman J, Marino M, Hoopes M, Bailey SR, Gold R, O'Malley J, Angier H, Nelson C, Cottrell E, Devoe J. Supporting health insurance expansion: do electronic health records have valid insurance verification and enrollment data? J Am Med Inform Assoc. 2015 Jul;22(4):909-13. doi: 10.1093/jamia/ocv033. Epub 2015 Apr 17.
citation: DeVoe JE, Crawford C, Angier H, O'Malley J, Gallia C, Marino M, Gold R. The Association Between Medicaid Coverage for Children and Parents Persists: 2002-2010. Matern Child Health J. 2015 Aug;19(8):1766-74. doi: 10.1007/s10995-015-1690-5.
citation: Gold R, Burdick T, Angier H, Wallace L, Nelson C, Likumahuwa-Ackman S, Sumic A, DeVoe JE. Improve Synergy Between Health Information Exchange and Electronic Health Records to Increase Rates of Continuously Insured Patients. EGEMS (Wash DC). 2015 Aug 6;3(1):1158. doi: 10.13063/2327-9214.1158. eCollection 2015.
citation: DeVoe JE, Tillotson CJ, Marino M, O'Malley J, Angier H, Wallace LS, Gold R. Trends in Type of Health Insurance Coverage for US Children and Their Parents, 1998-2011. Acad Pediatr. 2016 Mar;16(2):192-9. doi: 10.1016/j.acap.2015.06.009. Epub 2015 Aug 18.
citation: Angier H, Marino M, Sumic A, O'Malley J, Likumahuwa-Ackman S, Hoopes M, Nelson C, Gold R, Cohen D, Dickerson K, DeVoe JE. Innovative methods for parents and clinics to create tools for kids' care (IMPACCT Kids' Care) study protocol. Contemp Clin Trials. 2015 Sep;44:159-163. doi: 10.1016/j.cct.2015.08.010. Epub 2015 Aug 18.
citation: Arkind J, Likumahuwa-Ackman S, Warren N, Dickerson K, Robbins L, Norman K, DeVoe JE. Lessons Learned from Developing a Patient Engagement Panel: An OCHIN Report. J Am Board Fam Med. 2015 Sep-Oct;28(5):632-8. doi: 10.3122/jabfm.2015.05.150009.
citation: Likumahuwa-Ackman S, Angier H, Sumic A, Harding RL, Cottrell EK, Cohen DJ, Nelson CA, Burdick TE, Wallace LS, Gallia C, DeVoe JE. IMPACCT Kids' Care: a real-world example of stakeholder involvement in comparative effectiveness research. J Comp Eff Res. 2015 Aug;4(4):351-7. doi: 10.2217/cer.15.24.
citation: Hoopes MJ, Angier H, Gold R, Bailey SR, Huguet N, Marino M, DeVoe JE. Utilization of Community Health Centers in Medicaid Expansion and Nonexpansion States, 2013-2014. J Ambul Care Manage. 2016 Oct-Dec;39(4):290-8. doi: 10.1097/JAC.0000000000000123.
citation: Hatch B, Tillotson C, Angier H, Marino M, Hoopes M, Huguet N, DeVoe J. Using the electronic health record for assessment of health insurance in community health centers. J Am Med Inform Assoc. 2016 Sep;23(5):984-90. doi: 10.1093/jamia/ocv179. Epub 2016 Jan 23.
citation: DeVoe JE, Hoopes M, Nelson CA, Cohen DJ, Sumic A, Hall J, Angier H, Marino M, O'Malley JP, Gold R. Electronic health record tools to assist with children's insurance coverage: a mixed methods study. BMC Health Serv Res. 2018 May 10;18(1):354. doi: 10.1186/s12913-018-3159-x.