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Clinical Trials/NCT01739166
NCT01739166CompletedNot Applicable

Child Healthcare Excellence Center - A University-Practice-Public Partnership (CHEC-UPPP)

University Hospitals Cleveland Medical Center1 site in 1 country30 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Application of dental fluoride varnish for 12-36 month olds

Study Overview

Brief Summary

Funded by the Ohio Department of Job and Family Services - Medicaid Technical Assistance and Policy Program (MEDTAPP), the "Child Health Excellence Center - a University-Practice-Public Partnership" (CHEC-UPPP) focuses on improving the health of Ohio's children in 3 target areas: 1) prevention of dental decay; 2) detection and management of overweight and obesity; and 3) lead screening. These topics represent critical public health issues for Ohio's children.

The study is based on strong evidence that interventions are needed to improve practice in the target areas and that achieving these goals represents fundamental improvements in child health care that would reduce morbidity and costs. The approach for the study involves a trained Practice Facilitator (PF) working with multiple pediatric and family medicine practices to create change tailored to individual practice preferences and methods of operation.

Our overall hypothesis is that a university-community consortium, utilizing evidence-based methods (involving education plus a facilitated, practice-tailored approach) will increase the rates of targeted services in primary care practices.

Detailed Description

The research design involves a sample of 30 primary care practices (a combination of pediatric and family medicine) from across Northeast Ohio who have at least a 20% Medicaid patient population. We are using a cross-over study design. After the run-in period during which baseline data is collected via chart review and all practices receive basic education in the 3 focal areas of lead, dental and obesity screening, the practices will be randomly assigned to one of two groups.

The Phase 1 group will receive the practice-tailored intervention with the Practice Facilitator (PF) starting immediately after randomization and continuing for 6 months. The Phase 2 group will start their practice-tailored intervention with the PF 4 months post-randomization and continue through post-randomization month 10.

This design gives us a natural 'control' group (Phase 2 group) for the first four months post-randomization. The Phase 2 group will have had the same Run-in Phase education as the Phase 1 group, but will not be starting the practice-tailored intervention with the study facilitator for 4 months, at which time they will cross-over to their Intervention Phase.

Both Phase 1 and Phase 2 groups will have a 2 month Follow-up Phase after the completion of their 6 month Intervention Phase. During the Follow-up Phase they will strive to continue reaching the outcome measures on their own without the support of the PF. This will give us an opportunity to assess short-term sustainability of the rates of delivery of services achieved during the Intervention Phase.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Practice site has 20% or more Medicaid patient population
  • •Practice is located in Northeast Ohio

Exclusion Criteria

  • •Practice has less than 20% Medicaid patient population
  • •Practice is out of the targeted area

Arms & Interventions

Practice-tailored intervention - Early/Phase 1

Experimental

During the 6 month Intervention Phase the Practice Facilitator works with each practice to create changes that are tailored to their individual preferences and methods of operation. Sites randomized to Early/Phase 1 start their 6 month intervention immediately after randomization.

Intervention: Practice-tailored intervention to increase rates of targeted services (Other)

Practice-tailored intervention - Late/Phase 2

Experimental

The Phase 2 group will start the practice-tailored intervention with the study facilitator 4 months post-randomization and continue through post-randomization month 10.

Intervention: Practice-tailored intervention to increase rates of targeted services (Other)

Outcomes

Primary Outcomes

Application of dental fluoride varnish for 12-36 month olds

Time Frame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase

Assessing the rate of dental fluoride varnish application for eligible children 12-36 months of age is our primary outcome. This is assessed by chart review in the medical record for the index visit or within the preceding 6 months.

Lead screening for at-risk 12 and 24 month olds

Time Frame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase

Assessing the rate of lead screening for eligible (i.e., at risk) 12 and 24 month old children is our primary outcome. This is assessed by chart review in the medical record for the index visit.

Identification of BMI percentile and weight diagnosis catergory in 2-17 year olds

Time Frame: At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase

Assessing the rate of recorded BMI and 2) and rate of accurate recorded weight diagnosis category (underweight \< 5th percentile; healthy weight 5th percentile -\<85th percentile; overweight 85th percentile - \<95th percentile; or obese \> 95th percentile) for children 2-17 years of age is our primary outcome. This is assessed by chart review in the medical record for the index visit.

Secondary Outcomes

  • Rates of elevated lead levels and appropriate follow-up for 12 and 24 months lead screenings(At baseline, every 2 months during the 6 month Intervention and after the 2 month Follow-up Phase)
  • Rates of appropriate counseling for nutrition & activity and appropriate screening for co-morbidities(At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase)
  • Rates of oral screening and referral to a dentist for 12-36 month olds(At baseline, every 2 months during the 6 month Intervention Phase, and after the 2 month Follow-up Phase)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sharon Meropol, MD, PhD

Principal Investigator

University Hospitals Cleveland Medical Center

Study Sites (1)

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