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

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ClinicalTrials.gov Identifier: NCT01264718
Recruitment Status : Completed
First Posted : December 22, 2010
Results First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Glenn Flores, MD, Connecticut Children's Medical Center

Tracking Information
First Submitted Date  ICMJE December 20, 2010
First Posted Date  ICMJE December 22, 2010
Results First Submitted Date  ICMJE March 14, 2017
Results First Posted Date  ICMJE April 19, 2019
Last Update Posted Date April 19, 2019
Study Start Date  ICMJE December 2010
Actual Primary Completion Date May 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2010)
Randomized Trial Questionnaire [ Time Frame: Baseline and Monthly for one year ]
Orally administered questionnaire for demographics and on-going record of obtaining and maintaining insurance for child-subject as reported by parent. This is to include number of days to obtain insurance and episodic coverage (loss and reinstatement of coverage). Additionally, monitoring and assessing direct healthcare costs, insurance enrollment fees and intervention costs. Outcomes will be monitored by a Research Technician who will be blinded to the subject group assignment.
Change History Complete list of historical versions of study NCT01264718 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • Number of Days From Study Enrollment to Obtaining Coverage [ Time Frame: One year after enrollment ]
    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.
  • Parental Satisfaction With the Process of Obtaining Coverage for Child [ Time Frame: One year after enrollment ]
    Parental satisfaction is assessed both using a five-point Likert-scale and open-ended questions
  • Intervention Cost-Effectiveness Ratio (ICER) [ Time Frame: One year after enrollment ]
    The difference in total costs between the intervention group and controls
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2010)
Health status and parental satisfaction [ Time Frame: Monthly for one year ]
Review of health status, quality of life for the child, access to healthcare, unmet healthcare needs, use of health services, and quality of pediatric care conducted orally via telephone or home visit. Parental satisfaction will be measured separately according to group assignment. Overall satisfaction will be be determined for each maneuver. On a five-point Likert scale & open-ended questions regarding satisfaction with obtaining health insurance.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children
Official Title  ICMJE A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Uninsured Children Eligible for Medicaid or CHIP
Intervention  ICMJE Behavioral: Parent 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.
Other Name: Kids' HELP
Study Arms  ICMJE
  • No Intervention: Control
    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.
  • Experimental: Parent Mentors
    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.
    Intervention: Behavioral: Parent Mentors
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2019)
329
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2010)
300
Actual Study Completion Date  ICMJE May 31, 2016
Actual Primary Completion Date May 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01264718
Other Study ID Numbers  ICMJE 082010-138
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Glenn Flores, MD, Connecticut Children's Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Glenn Flores, M.D. Connecticut Children's Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP