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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 : Unknown
Verified May 2015 by Glenn Flores, University of Texas Southwestern Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : December 22, 2010
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

9.6 million US Children (13%) have no health insurance, Latino and African-American children account for 57% of uninsured children, although comprising only 37% of all US Children. Studies show that being uninsured has a negative impact on children's health, healthcare, and mortality, however, insuring children results in improved health and healthcare. About 70% of uninsured US children (6 million) are eligible for but not enrolled in Medicaid or the Children's Health Insurance Program (CHIP), innovative strategies are needed to insure more children and eliminate disparities. This is the first randomized controlled trial comparing the effectiveness of parent mentors (PMs) to traditional Medicaid/CHIP outreach and enrollment in insuring uninsured minority children. The primary study aims are to evaluate whether PMs are more effective and more cost-effective than traditional Medicaid/CHIP outreach and enrollment in uninsured children. The secondary aim is to determine whether children who obtain health insurance experience improvements in healthcare access, health status, use of services, and other health outcomes.

Subjects will be 300 Dallas County uninsured and Medicaid/CHIP eligible Latino and African-American children (90% of insured children) and their parent/guardian. Subjects will be randomized to PMs or a control group receiving traditional Medicaid/CHIP outreach. PMs are experienced parents who have a child currently covered by Medicaid/CHIP. PMs will undergo intensive training, and will be paired with intervention subjects and their families, for whom they will provide information on Medicaid/CHIP eligibility, help complete/submit insurance applications, act as a liaison, and assist in maintaining coverage. Primary outcomes will include obtaining health insurance, coverage continuity, time interval to obtain coverage, parental satisfaction with the process of obtaining insurance and costs; secondary outcomes will include access to care, health status, use of services, quality of life, Parental satisfaction, financial burden, and missed school/parental work days. Subjects will be contacted monthly for 1 year to monitor outcomes by a blinded assessor. Achievement of study aims has the potential to contribute to reducing racial/ethnic disparities, and advancing knowledge and practice of child health policy. This intervention could serve as a national model for insuring uninsured children and reducing racial/ethnic disparities in insurance coverage.


Condition or disease Intervention/treatment
Uninsured Children Eligible for Medicaid or CHIP Behavioral: Effects of Parent Mentors on Insuring Minority Children

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children
Study Start Date : December 2010
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicaid
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control
After random assignment to the control group, minority low-income parents of a Medicaid/CHIP eligible child will receive only the traditional outreach regarding enrolling in Medicaid/CHIP.
Behavioral: Effects of Parent Mentors on Insuring Minority Children
After random assignment to the Parent Mentor group,the minority low-income parent of a Medicaid/CHIP eligible child will meet with a Parent Mentor to receive instruction and help on completing, submitting, and maintaining Medicaid/CHIP insurance for their child.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264718


Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
UT Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Glenn Flores, M.D. University of Texas Southwestern Medical Center
More Information

Responsible Party: Glenn Flores, Director, Division of General Pediatrics Professor of Pediatrics, Clinical Sciences, and Public Health The Judith and Charles Ginsburg Chair in Pediatrics Director, Academic General Pediatrics Fellowship, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01264718     History of Changes
Other Study ID Numbers: 082010-138
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Glenn Flores, University of Texas Southwestern Medical Center:
minority health
child
Medicaid