Trial Outcomes & Findings for A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children (NCT NCT01264718)
NCT ID: NCT01264718
Last Updated: 2019-04-19
Results Overview
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.
COMPLETED
NA
329 participants
One year after enrollment
2019-04-19
Participant Flow
Participant milestones
| Measure |
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.
|
Control: No Intervention
Families received traditional Medicaid/CHIP outreach
|
|---|---|---|
|
Overall Study
STARTED
|
172
|
157
|
|
Overall Study
COMPLETED
|
123
|
114
|
|
Overall Study
NOT COMPLETED
|
49
|
43
|
Reasons for withdrawal
| Measure |
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.
|
Control: No Intervention
Families received traditional Medicaid/CHIP outreach
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
9
|
15
|
|
Overall Study
Loss of Medicaid/CHIP eligibility
|
37
|
26
|
Baseline Characteristics
A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children
Baseline characteristics by cohort
| Measure |
Intervention: Parent Mentors
n=123 Participants
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.
|
Control: No Intervention
n=114 Participants
Families received traditional Medicaid/CHIP outreach
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
123 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7 years
n=5 Participants
|
7 years
n=7 Participants
|
7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
80 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American/Black
|
43 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
123 participants
n=5 Participants
|
114 participants
n=7 Participants
|
237 participants
n=5 Participants
|
|
Number of months child had been uninsured
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One year after enrollmentPopulation: 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)
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.
Outcome measures
| Measure |
Intervention: Parent Mentors
n=123 Participants
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.
|
Control: No Intervention
n=114 Participants
Families received traditional Medicaid/CHIP outreach
|
|---|---|---|
|
Number of Children With Health Insurance
Child obtained health insurance
|
117 Participants
|
78 Participants
|
|
Number of Children With Health Insurance
Child did not obtain health insurance
|
6 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: One year after enrollmentPopulation: 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)
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.
Outcome measures
| Measure |
Intervention: Parent Mentors
n=123 Participants
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.
|
Control: No Intervention
n=114 Participants
Families received traditional Medicaid/CHIP outreach
|
|---|---|---|
|
Number of Days From Study Enrollment to Obtaining Coverage
|
62 Days
Interval 33.0 to 112.0
|
140 Days
Interval 61.0 to 236.0
|
SECONDARY outcome
Timeframe: One year after enrollmentPopulation: 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).
Parental satisfaction is assessed both using a five-point Likert-scale and open-ended questions
Outcome measures
| Measure |
Intervention: Parent Mentors
n=121 Participants
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.
|
Control: No Intervention
n=113 Participants
Families received traditional Medicaid/CHIP outreach
|
|---|---|---|
|
Parental Satisfaction With the Process of Obtaining Coverage for Child
1- Parent very unsatisfied with process
|
2 Participants
|
13 Participants
|
|
Parental Satisfaction With the Process of Obtaining Coverage for Child
2- Parent unsatisfied with process
|
5 Participants
|
10 Participants
|
|
Parental Satisfaction With the Process of Obtaining Coverage for Child
3- Parent uncertain about process
|
12 Participants
|
17 Participants
|
|
Parental Satisfaction With the Process of Obtaining Coverage for Child
4- Parent satisfied with process
|
33 Participants
|
45 Participants
|
|
Parental Satisfaction With the Process of Obtaining Coverage for Child
5- Parent very satisfied with process
|
69 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: One year after enrollmentPopulation: 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)
The difference in total costs between the intervention group and controls
Outcome measures
| Measure |
Intervention: Parent Mentors
n=123 Participants
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.
|
Control: No Intervention
n=114 Participants
Families received traditional Medicaid/CHIP outreach
|
|---|---|---|
|
Intervention Cost-Effectiveness Ratio (ICER)
PM stipends- total cost
|
53,838 Dollars
|
0 Dollars
|
|
Intervention Cost-Effectiveness Ratio (ICER)
PM travel and supplies- total cost
|
5,195 Dollars
|
0 Dollars
|
|
Intervention Cost-Effectiveness Ratio (ICER)
PM training sessions and meetings- total cost
|
1411.61 Dollars
|
0 Dollars
|
|
Intervention Cost-Effectiveness Ratio (ICER)
Program coordinator salary- total cost
|
25,350 Dollars
|
0 Dollars
|
|
Intervention Cost-Effectiveness Ratio (ICER)
ED visits- total cost
|
60,885 Dollars
|
62,730 Dollars
|
|
Intervention Cost-Effectiveness Ratio (ICER)
Hospitalizations- total cost
|
58,431 Dollars
|
81,537 Dollars
|
|
Intervention Cost-Effectiveness Ratio (ICER)
ICU stays- total cost
|
74,742 Dollars
|
277,094 Dollars
|
|
Intervention Cost-Effectiveness Ratio (ICER)
Wage loss/other costs of caring for sick child
|
12,985 Dollars
|
33,589 Dollars
|
|
Intervention Cost-Effectiveness Ratio (ICER)
Total for all costs
|
291,426 Dollars
|
454,647 Dollars
|
Adverse Events
Intervention: Parent Mentors
Control: No Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Glenn Flores, Distinguished Chair of Health Policy Research
Medica Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place