IMPACCT for Kids' Care (IMPACCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02298361|
Recruitment Status : Completed
First Posted : November 21, 2014
Results First Posted : June 2, 2016
Last Update Posted : June 2, 2016
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.
|Condition or disease||Intervention/treatment|
|Insurance Status/Stability||Other: Health insurance outreach IT tools|
Summary of protocol changes made:
- 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.
- 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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||27251 participants|
|Official Title:||Innovative Methods for Parents And Clinics to Create Tools (IMPACCT) for Kids' Care|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
Other: Health insurance outreach IT tools
IT tools that support Community Health Centers in children's health insurance outreach efforts ("insurance outreach IT tools"), adapted from tools proven to support chronic disease management.
Within-clinic comparison patients
Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
Control clinic comparison patients
Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
- Percent of Study Period Covered by Medicaid [ Time Frame: 6 months pre- through 16 months post-tool implementation ]Percent of total days in 22-month assessment period that each child was covered by Medicaid insurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources).
- Proportion of Patients Who Gained Medicaid Coverage [ Time Frame: 6 months pre- through 16 months post-tool implementation ]Proportion of participants who gained Medicaid coverage after a period of uninsurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources) and who had partial coverage during the study period (i.e., patients with 100% coverage were not 'eligible' to gain coverage).
- Proportion of Patients Who Lost Medicaid Coverage [ Time Frame: 6 months pre- through 16 months post-tool implementation ]Proportion of participants who lost Medicaid coverage after a period of insurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources) and who had partial coverage during the study period (i.e., patients with 100% coverage were not 'eligible' to lose coverage).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298361
|Principal Investigator:||Jennifer DeVoe, MD, DPhil||OCHIN, OHSU|
|Study Director:||Christine Nelson, RN, PhD||OCHIN, Inc.|