Uninsured Children Eligible for Medicaid or CHIPNCT01264718
A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children
A study testing Parent Mentors in people with Uninsured Children Eligible for Medicaid or CHIP, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Uninsured Children Eligible for Medicaid or CHIP
- What is being tested?
- Parent Mentors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2010to 31 May 2016
- Phase
- Interventional
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The parent/guardian is a primary caretaker of a least one child 0-18 years old who currently has no health insurance
- The parent/guardian self-identifies the uninsured child as Hispanic/Latino, African-American/Black, or both
- The uninsured child is eligible for either Medicaid or CHIP
- 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).
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT Southwestern
Dallas, Texas, 75390
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
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.
Read the 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.
- Being tested
- Parent Mentors
- Keywords
- minority health, child, Medicaid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent MentorsBehavioural
Also called Kids' HELP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Parent Mentors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year after enrollment
Secondary outcomes (3)
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.
Measured: One year after enrollment
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
Measured: One year after enrollment
Intervention Cost-Effectiveness Ratio (ICER)
The difference in total costs between the intervention group and controls
Measured: One year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startDec 2010
- Primary completion31 May 2016
- Study completion31 May 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 (5)Papers the sponsor has linked to this study.
- Other trials for Uninsured Children Eligible for Medicaid or CHIPStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn Flores, MD, Connecticut Children's Medical Center
- Investigators
- Glenn Flores, M.D., Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264718
- Sponsor's protocol ID
- 082010-138
- Status last verified
- Jan 2019
- First submitted
- 20 Dec 2010
- Last updated
- 19 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25476583Flores 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.
PubMed 25447369Flores 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.
PubMed 27244706Flores 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.
PubMed 27000795Flores 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.
PubMed 28378019
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children
- ClinicalTrials.gov ID
- NCT01264718
- Acronym / sponsor ID
- 082010-138
- Keywords
- minority health, child, Medicaid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Posted 19 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Parent MentorsAfter 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The parent/guardian is a primary caretaker of a least one child 0-18 years old who currently has no health insurance
- The parent/guardian self-identifies the uninsured child as Hispanic/Latino, African-American/Black, or both
- The uninsured child is eligible for either Medicaid or CHIP
- 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).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Parent MentorsAlso: Kids' HELPAfter 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. | Behavioural | Parent Mentors |
Primary outcome
Number of Children With Health Insurance
Time frame: One year after enrollment
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.
3 secondary outcomes
Number of Days From Study Enrollment to Obtaining Coverage
Time frame: One year after enrollment
Parental Satisfaction With the Process of Obtaining Coverage for Child
Time frame: One year after enrollment
Intervention Cost-Effectiveness Ratio (ICER)
Time frame: One year after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25476583Flores 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.
- Background: PubMed 25447369Flores 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.
- Background: PubMed 27244706Flores 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.
- Background: PubMed 27000795Flores 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.
- Background: PubMed 28378019Flores 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: 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 childrenLink provided by the sponsor.
- Manuscript: A successful program for training parent mentors to provide assistance with obtaining health insurance for uninsured childrenLink provided by the sponsor.
- 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 needsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Glenn Flores, M.D. principal investigator
Connecticut Children's Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Mentors in people with Uninsured Children Eligible for Medicaid or CHIP, run by University of Texas Southwestern Medical Center at 2 sites in United States.
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 4 inclusion and 0 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 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 19 Apr 2019). 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?
Number of Children With Health Insurance (time frame: One year after enrollment). 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 NCT01264718, which also lists 5 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 19 Apr 2019.