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The Kids' HELP trial rigorously documented that a Parent Mentor intervention results in multiple benefits: more children are insured faster, children's access to healthcare and parental satisfaction improve, quality of well-child care is enhanced, thousands of dollars are saved per child, jobs are created, disparities are eliminated, and the intervention potentially could save our nation billions of dollars.
Background: Six million US children are uninsured, despite two-thirds being eligible for Medicaid/Children's Health Insurance Program (CHIP), and minority children are at especially high risk. The most effective way to insure uninsured children, however, is unclear.
Methods: We conducted a randomized trial of the effects of parent mentors (PMs) on insuring uninsured minority children. PMs were experienced parents with >=1 Medicaid/CHIP-covered child who received 2 days of training, then assisted families for 1 year with insurance applications, retaining coverage, medical homes, and social needs; controls received traditional Medicaid/CHIP outreach. The primary outcome was obtaining insurance 1 year post-enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | After randomization to the control group, minority low-income parents of uninsured, Medicaid/CHIP-eligible children received only traditional Medicaid/Children's Health Insurance Program (CHIP) outreach and enrollment. | |
| Parent Mentors | Experimental | After randomization to the Parent Mentor group, minority low-income parents of uninsured Medicaid/CHIP-eligible children received face-to-face instruction and guidance from Parent Mentors on obtaining and keeping Medicaid/CHIP for their child; getting a doctor, dentist, and pharmacist; and addressing social determinants of health. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent Mentors | Behavioral | After random assignment to the Parent Mentor group, minority low-income parents of Medicaid/CHIP eligible children met with Parent Mentors to receive instruction and help on completing, submitting applications for, and maintaining Medicaid/CHIP coverage for their child. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Children With Health Insurance | A study child is considered insured once official written notification of insurance is confirmed, either through an electronic or hard copy of the state coverage letter, or via verification from the Texas Health and Human Services Center. | One year after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days From Study Enrollment to Obtaining Coverage | Zero time (the point at which the maneuver is imposed) is the data and time of study enrollment. Occurrence of the main outcome event is the date and time of official notification that the child is insured. | One year after enrollment |
| Parental Satisfaction With the Process of Obtaining Coverage for Child |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Flores, M.D. | Connecticut Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States | ||
| UT Southwestern |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25476583 | Background | Flores G, Walker C, Lin H, Lee M, Fierro M, Henry M, Massey K, Portillo A. Design, methods, and baseline characteristics of the Kids' Health Insurance by Educating Lots of Parents (Kids' HELP) trial: a randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children. Contemp Clin Trials. 2015 Jan;40:124-37. doi: 10.1016/j.cct.2014.11.015. Epub 2014 Dec 2. | |
| 25447369 |
| Label | URL |
|---|---|
| Manuscript: Design, methods, and baseline characteristics of the Kids' Health Insurance by Educating Lots of Parents (Kids' HELP) trial: A randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention: Parent Mentors | Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training. |
| FG001 | Control: No Intervention | Families received traditional Medicaid/CHIP outreach |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
237 included in primary analysis: 123 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, and 9 withdrew prior to one-year follow-up); and 114 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, and 15 withdrew prior to one-year follow-up)
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention: Parent Mentors | Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training. |
| BG001 | Control: No Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Children With Health Insurance | A study child is considered insured once official written notification of insurance is confirmed, either through an electronic or hard copy of the state coverage letter, or via verification from the Texas Health and Human Services Center. | 237 included in primary analysis: 123 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, and 9 withdrew prior to one-year follow-up); and 114 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, and 15 withdrew prior to one-year follow-up) | Posted | Count of Participants | Participants | One year after enrollment |
|
This project involved a behavioral intervention (not a drug- or device-based intervention), so no participants were at risk of adverse events and no adverse event assessment process was instituted.
This project involved a behavioral intervention (not a drug- or device-based intervention), so no participants were at risk of adverse events and no adverse event assessment process was instituted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention: Parent Mentors | Families assisted for one year with insurance applications, retaining coverage, medical homes, and social needs by experienced parents (Parent Mentors) with at least one Medicaid/CHIP-covered child who received two days of training. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Glenn Flores, Distinguished Chair of Health Policy Research | Medica Research Institute | 952-992-3367 | Glenn.Flores@medica.com |
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Parental satisfaction is assessed both using a five-point Likert-scale and open-ended questions |
| One year after enrollment |
| Intervention Cost-Effectiveness Ratio (ICER) | The difference in total costs between the intervention group and controls | One year after enrollment |
| Dallas |
| Texas |
| 75390 |
| United States |
| Background |
| Flores G, Walker C, Lin H, Lee M, Fierro M, Henry M, Massey K, Portillo A. A successful program for training parent mentors to provide assistance with obtaining health insurance for uninsured children. Acad Pediatr. 2015 May-Jun;15(3):275-81. doi: 10.1016/j.acap.2014.09.011. Epub 2014 Dec 1. |
| 27244706 | Background | Flores G, Lin H, Walker C, Lee M, Currie JM, Allgeyer R, Fierro M, Henry M, Portillo A, Massey K. Parent Mentors and Insuring Uninsured Children: A Randomized Controlled Trial. Pediatrics. 2016 Apr;137(4):e20153519. doi: 10.1542/peds.2015-3519. Epub 2016 Mar 17. |
| 27000795 | Background | Flores G, Lin H, Walker C, Lee M, Portillo A, Henry M, Fierro M, Massey K. A cross-sectional study of parental awareness of and reasons for lack of health insurance among minority children, and the impact on health, access to care, and unmet needs. Int J Equity Health. 2016 Mar 22;15:44. doi: 10.1186/s12939-016-0331-y. |
| 28378019 | Background | Flores G, Portillo A, Lin H, Walker C, Fierro M, Henry M, Massey K. A successful approach to minimizing attrition in racial/ethnic minority, low-income populations. Contemp Clin Trials Commun. 2017 Mar;5:168-174. doi: 10.1016/j.conctc.2017.01.009. Epub 2017 Feb 14. |
| Manuscript: A successful program for training parent mentors to provide assistance with obtaining health insurance for uninsured children | View source |
| Manuscript: A cross-sectional study of parental awareness of and reasons for lack of health insurance among minority children, and the impact on health, access to care, and unmet needs | View source |
| Loss of Medicaid/CHIP eligibility |
|
Families received traditional Medicaid/CHIP outreach |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of months child had been uninsured | Median | Inter-Quartile Range | participants |
|
| OG001 | Control: No Intervention | Families received traditional Medicaid/CHIP outreach |
|
|
| Secondary | Number of Days From Study Enrollment to Obtaining Coverage | Zero time (the point at which the maneuver is imposed) is the data and time of study enrollment. Occurrence of the main outcome event is the date and time of official notification that the child is insured. | 237 included in primary analysis: 123 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, and 9 withdrew prior to one-year follow-up); and 114 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, and 15 withdrew prior to one-year follow-up) | Posted | Median | Inter-Quartile Range | Days | One year after enrollment |
|
|
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| Secondary | Parental Satisfaction With the Process of Obtaining Coverage for Child | Parental satisfaction is assessed both using a five-point Likert-scale and open-ended questions | 121 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, 9 withdrew prior to one-year follow-up, 2 did not answer); and 113 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, 15 withdrew prior to one-year follow-up, and 1 did not answer). | Posted | Count of Participants | Participants | One year after enrollment |
|
|
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| Secondary | Intervention Cost-Effectiveness Ratio (ICER) | The difference in total costs between the intervention group and controls | 237 included in primary analysis: 123 from the intervention group (37 excluded due to loss of Medicaid/CHIP eligibility, 3 were lost to follow-up, and 9 withdrew prior to one-year follow-up); and 114 from the control group (26 due to loss of Medicaid/CHIP eligibility, 2 were lost to follow-up, and 15 withdrew prior to one-year follow-up) | Posted | Number | Dollars | One year after enrollment |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control: No Intervention | Families received traditional Medicaid/CHIP outreach | 0 | 0 | 0 | 0 | 0 | 0 |
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| 3- Parent uncertain about process |
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| 4- Parent satisfied with process |
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| 5- Parent very satisfied with process |
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| PM training sessions and meetings- total cost |
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| Program coordinator salary- total cost |
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| ED visits- total cost |
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| Hospitalizations- total cost |
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| ICU stays- total cost |
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| Wage loss/other costs of caring for sick child |
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| Total for all costs |
|
| ICER |
| 4,185.15 |
| 2-Sided |
The estimated value is the savings for each percent increase in children obtaining insurance per year. |
| Other |
The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children. |