A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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||Phase|
|Uninsured Children Eligible for Medicaid or CHIP||Behavioral: Effects of Parent Mentors on Insuring Minority Children||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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|
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.
- 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.
- 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.
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
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75235|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Glenn Flores, M.D.||University of Texas Southwestern Medical Center|