Insurance Status/StabilityIMPACCTNCT02298361
IMPACCT for Kids' Care
An observational study of Insurance Status/Stability, run by OCHIN, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Insurance Status/Stability
- What is being tested?
- Health insurance outreach IT tools
- How many people
- 27,251 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Feb 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- age 0-19
- established patient (>=1 clinical visit at a study clinic in the assessment period)
Who cannot join
- age > 19
- not an established patient
About this study
Official title: Innovative Methods for Parents And Clinics to Create Tools (IMPACCT) for Kids' Care
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.
Read the detailed description
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.
- Conditions
- Insurance Status/Stability
- Being tested
- Health insurance outreach IT tools
- 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
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health insurance outreach IT toolsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention patients | Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used Receives: Other: Health insurance outreach IT tools | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Study Period Covered by Medicaid
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).
Measured: 6 months pre- through 16 months post-tool implementation
Proportion of Patients Who Gained Medicaid Coverage
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).
Measured: 6 months pre- through 16 months post-tool implementation
Proportion of Patients Who Lost Medicaid Coverage
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).
Measured: 6 months pre- through 16 months post-tool implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startMar 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Insurance Status/StabilityStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 27,251 participants (actual)
Sponsor and investigators
- Lead sponsor
- OCHIN, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Jennifer DeVoe, MD, DPhil, Principal investigator, OCHIN, OHSUChristine Nelson, RN, PhD, Study director, OCHIN, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298361
- Sponsor's protocol ID
- PCORI Award (308)
- Acronym
- IMPACCT
- Status last verified
- Apr 2016
- First submitted
- 5 Nov 2014
- Last updated
- 2 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24019280Angier 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.
PubMed 24562505DeVoe 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.
PubMed 24594562DeVoe 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.
PubMed 25070735Hatch 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.
PubMed 24249814Angier 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.
PubMed 25381078DeVoe 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.
PubMed 25384821Angier 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.
PubMed 25583886Heintzman 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.
PubMed 25888586DeVoe 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.
PubMed 25874876Gold 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.
PubMed 26355818DeVoe 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.
PubMed 26297668Angier 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.
PubMed 26291916Arkind 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.
PubMed 26355135Likumahuwa-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.
PubMed 26274796
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Methods for Parents And Clinics to Create Tools (IMPACCT) for Kids' Care
- ClinicalTrials.gov ID
- NCT02298361
- Acronym / sponsor ID
- IMPACCT / PCORI Award (308)
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,251 participants (actual)
- Lead sponsor
- OCHIN, Inc.University, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- Mar 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Posted 2 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention patients | – | Other: Health insurance outreach IT toolsCommunity Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used |
| 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 |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- age 0-19
- established patient (>=1 clinical visit at a study clinic in the assessment period)
Key exclusion criteria (2 listed)
- age > 19
- not an established patient
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 |
|---|---|---|
| Health insurance outreach IT toolsIT 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. | Other | Intervention patients |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24019280Devoe 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.
- Background: PubMed 24562505Angier 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.
- Background: PubMed 24594562DeVoe 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.
- Background: PubMed 25070735DeVoe 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.
- Background: PubMed 24249814Hatch 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.
- Background: PubMed 25381078Angier 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.
- Background: PubMed 25384821DeVoe 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.
- Background: PubMed 25583886Angier 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.
- Background: PubMed 25888586Heintzman 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.
- Background: PubMed 25874876DeVoe 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.
- Background: PubMed 26355818Gold 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.
- Background: PubMed 26297668DeVoe 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.
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.
Jennifer DeVoe, MD, DPhil principal investigator
OCHIN, OHSU
Christine Nelson, RN, PhD study director
OCHIN, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Insurance Status/Stability, run by OCHIN, Inc..
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 2 inclusion and 2 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 2 Jun 2016. 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?
Yes. Results are posted in the registry (first posted 2 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Study Period Covered by Medicaid (time frame: 6 months pre- through 16 months post-tool implementation). The study lists 3 primary outcomes in all. 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 NCT02298361, which also lists 18 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 2 Jun 2016.