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A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children

A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01264718
Enrollment
329
Registered
2010-12-22
Start date
2010-12-31
Completion date
2016-05-31
Last updated
2019-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uninsured Children Eligible for Medicaid or CHIP

Keywords

minority health, child, Medicaid

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALParent Mentors

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.

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

Inclusion criteria

1. The parent/guardian is a primary caretaker of a least one child 0-18 years old who currently has no health insurance 2. The parent/guardian self-identifies the uninsured child as Hispanic/Latino, African-American/Black, or both 3. The uninsured child is eligible for either Medicaid or CHIP 4. The parent/guardian is willing to be contacted monthly by telephone, or in the form of a home visit (if no functioning telephone is present in the household).

Design outcomes

Primary

MeasureTime frameDescription
Number of Children With Health InsuranceOne year after enrollmentA 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.

Secondary

MeasureTime frameDescription
Number of Days From Study Enrollment to Obtaining CoverageOne year after enrollmentZero 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.
Parental Satisfaction With the Process of Obtaining Coverage for ChildOne year after enrollmentParental satisfaction is assessed both using a five-point Likert-scale and open-ended questions
Intervention Cost-Effectiveness Ratio (ICER)One year after enrollmentThe difference in total costs between the intervention group and controls

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
123
Control: No Intervention
Families received traditional Medicaid/CHIP outreach
114
Total237

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLoss of Medicaid/CHIP eligibility3726
Overall StudyLost to Follow-up32
Overall StudyWithdrawal by Subject915

Baseline characteristics

CharacteristicIntervention: Parent MentorsControl: No InterventionTotal
Age, Categorical
<=18 years
123 Participants114 Participants237 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous7 years7 years7 years
Number of months child had been uninsured6 participants8 participants7 participants
Race/Ethnicity, Customized
African-American/Black
43 Participants39 Participants82 Participants
Race/Ethnicity, Customized
Latino
80 Participants75 Participants155 Participants
Region of Enrollment
United States
123 participants114 participants237 participants
Sex: Female, Male
Female
72 Participants47 Participants119 Participants
Sex: Female, Male
Male
51 Participants67 Participants118 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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.

Time frame: One year after enrollment

Population: 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)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention: Parent MentorsNumber of Children With Health InsuranceChild obtained health insurance117 Participants
Intervention: Parent MentorsNumber of Children With Health InsuranceChild did not obtain health insurance6 Participants
Control: No InterventionNumber of Children With Health InsuranceChild obtained health insurance78 Participants
Control: No InterventionNumber of Children With Health InsuranceChild did not obtain health insurance36 Participants
Secondary

Intervention Cost-Effectiveness Ratio (ICER)

The difference in total costs between the intervention group and controls

Time frame: One year after enrollment

Population: 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)

ArmMeasureGroupValue (NUMBER)
Intervention: Parent MentorsIntervention Cost-Effectiveness Ratio (ICER)ICU stays- total cost74,742 Dollars
Intervention: Parent MentorsIntervention Cost-Effectiveness Ratio (ICER)ED visits- total cost60,885 Dollars
Intervention: Parent MentorsIntervention Cost-Effectiveness Ratio (ICER)Hospitalizations- total cost58,431 Dollars
Intervention: Parent MentorsIntervention Cost-Effectiveness Ratio (ICER)PM stipends- total cost53,838 Dollars
Intervention: Parent MentorsIntervention Cost-Effectiveness Ratio (ICER)PM travel and supplies- total cost5,195 Dollars
Intervention: Parent MentorsIntervention Cost-Effectiveness Ratio (ICER)PM training sessions and meetings- total cost1411.61 Dollars
Intervention: Parent MentorsIntervention Cost-Effectiveness Ratio (ICER)Program coordinator salary- total cost25,350 Dollars
Intervention: Parent MentorsIntervention Cost-Effectiveness Ratio (ICER)Wage loss/other costs of caring for sick child12,985 Dollars
Intervention: Parent MentorsIntervention Cost-Effectiveness Ratio (ICER)Total for all costs291,426 Dollars
Control: No InterventionIntervention Cost-Effectiveness Ratio (ICER)Total for all costs454,647 Dollars
Control: No InterventionIntervention Cost-Effectiveness Ratio (ICER)PM training sessions and meetings- total cost0 Dollars
Control: No InterventionIntervention Cost-Effectiveness Ratio (ICER)ED visits- total cost62,730 Dollars
Control: No InterventionIntervention Cost-Effectiveness Ratio (ICER)Wage loss/other costs of caring for sick child33,589 Dollars
Control: No InterventionIntervention Cost-Effectiveness Ratio (ICER)Hospitalizations- total cost81,537 Dollars
Control: No InterventionIntervention Cost-Effectiveness Ratio (ICER)Program coordinator salary- total cost0 Dollars
Control: No InterventionIntervention Cost-Effectiveness Ratio (ICER)PM stipends- total cost0 Dollars
Control: No InterventionIntervention Cost-Effectiveness Ratio (ICER)ICU stays- total cost277,094 Dollars
Control: No InterventionIntervention Cost-Effectiveness Ratio (ICER)PM travel and supplies- total cost0 Dollars
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.

Time frame: One year after enrollment

Population: 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)

ArmMeasureValue (MEDIAN)
Intervention: Parent MentorsNumber of Days From Study Enrollment to Obtaining Coverage62 Days
Control: No InterventionNumber of Days From Study Enrollment to Obtaining Coverage140 Days
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

Time frame: One year after enrollment

Population: 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).

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention: Parent MentorsParental Satisfaction With the Process of Obtaining Coverage for Child2- Parent unsatisfied with process5 Participants
Intervention: Parent MentorsParental Satisfaction With the Process of Obtaining Coverage for Child4- Parent satisfied with process33 Participants
Intervention: Parent MentorsParental Satisfaction With the Process of Obtaining Coverage for Child3- Parent uncertain about process12 Participants
Intervention: Parent MentorsParental Satisfaction With the Process of Obtaining Coverage for Child5- Parent very satisfied with process69 Participants
Intervention: Parent MentorsParental Satisfaction With the Process of Obtaining Coverage for Child1- Parent very unsatisfied with process2 Participants
Control: No InterventionParental Satisfaction With the Process of Obtaining Coverage for Child5- Parent very satisfied with process28 Participants
Control: No InterventionParental Satisfaction With the Process of Obtaining Coverage for Child1- Parent very unsatisfied with process13 Participants
Control: No InterventionParental Satisfaction With the Process of Obtaining Coverage for Child2- Parent unsatisfied with process10 Participants
Control: No InterventionParental Satisfaction With the Process of Obtaining Coverage for Child3- Parent uncertain about process17 Participants
Control: No InterventionParental Satisfaction With the Process of Obtaining Coverage for Child4- Parent satisfied with process45 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026